13JUL17: Kymanox Expanding, Hiring For Several New Positions
New Full-Time, Permanent Jobs Have Been Created at Kymanox
Research Triangle Park, North Carolina, United States | Thursday, 13 July 2017 | Kymanox management has approved seven new positions to usher in next growth spurt.
Kymanox is working hard to help clients bring modern medicine to patients in need. To support both current and upcoming commercialization programs for new biologics, drugs, devices, and combination products, seven new positions have been defined and budgeted for immediate hiring.
“These latest openings reflect the growth trajectory of Kymanox and the demand for our type of services,” stated CEO and Founder Stephen M. Perry, “and we are grateful to have this opportunity to onboard additional talent to expand the capabilities of our existing, high-performing team.” Six of the positions are located at Kymanox global headquarters in the Research Triangle Park (RTP) of North Carolina; the other position is located in the greater Atlanta, Georgia market. The positions are a blend of both senior, mid-level, and entry-level in all four verticals at Kymanox: Quality + Compliance, Validation, Process Operations, and Project Management.
Kymanox has hired at a pace of greater than one person per month for the last year and plans to continue at that pace for the foreseeable future. As part of recent hiring, the management team at Kymanox gained two high-profile persons in Richard A. Motruk for Director of CGMP Manufacturing and Technical Operations and Ash Patel for Senior Director of Client Services. The company is looking for individuals that want to help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible. With a reputation of providing unparalleled contract services, the existing team of process operations, quality assurance, regulatory compliance, validation, and project management experts provides an outstanding opportunity for learning and career advancement.
15MAR17:Kymanox Growth Continues, Signs Former Biogen Director
Ash Patel Joins Kymanox as New Senior Director of Client Services
RESEARCH TRIANGLE PARK, N.C., March 15, 2017 /PRNewswire/ — Mr. Patel joins Kymanox as an accomplished Operations Director with more than 20 years of experience in Supply Chain, Quality and Manufacturing Operations, Engineering, Capital Projects, Validation, and IT/Automation. He has General Management experience in multi-national biotech companies, such as Biogen and Diosynth Biotechnologies, with a strong record of compliance and value creation. Mr. Patel brings his highly developed communication and leadership skills to help Kymanox clients who are facing a variety of mission-critical challenges. Also valuable is his international experience that encompassed expansion in Europe, Asia Pacific, and South America with successful implementation of relevant EU and US regulatory requirements.
Mr. Patel earned a degree in Electrical Engineering from the University of Sunderland in England, and is a Master of Business Administration (MBA) from Copenhagen Business School in Denmark. He maintains professional certifications in Quality Auditing (ASQ-CQA), Supply Chain (CSCP), and Quality Management / Organizational Excellence (ASQ-CMQ/OE).
Mr. Patel states, “I am very excited to be part of this family. The offerings we provide to Biotech, Pharmaceutical, Medical Device, and Sterile Pharmacy organizations is expansive and inclusive of many disciplines. We are providing world-class service unmatched in quality and net value. I look forward to building on the strong foundations and relationships already here.”
“Ash is a strategic addition to the Kymanox team,” CEO and Founder Stephen M. Perry remarked. “His new role ensures our continuing ability to understand the complex problems facing our clients who are bringing modern medicines to patients in need around the world.”
06MAR17: Kymanox Expands, Signs New Director of Manufacturing Operations
Richard Motruk has over 15 years of combined experience in the biopharmaceutical and medical device industries. He earned a Bachelor of Science in Biochemistry and Molecular Biology from Penn State University. He brings his proven expertise leading both technical and operations-focused teams, small and large, to Kymanox and their client base.
In regards to his new employment at Kymanox, Mr. Motruk expressed his excitement in being able to leverage his diverse Life Science experience to assist clients improve their operational efficiencies while maintaining or exceeding their quality and compliance levels. “Kymanox is highly regarded for its expertise in many facets of CGMP manufacturing, chemistry, and related controls. The idea of joining an industry leader, and being able to parlay my operational leadership experience gained at bioMérieux, Teva, and OraSure, is very exciting,” he said.
Richard is a welcome addition to the Kymanox team, CEO and Founder Stephen M. Perry remarked. “With Richard now directing our established Process Operations and Validation groups, this new leadership position lays a solid foundation for future, sustainable growth,” he said. “This helps make the Kymanox team even more capable to address challenges with bringing modern medicines to patients in need across the globe.”
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22FEB17: Kymanox welcomes Ash Patel
Kymanox is pleased to announce the on-boarding of Ash Patel for the position of Senior Director of Client Services. He will be leading the Business Development team to expand the Kymanox Brand and help new clients.
07OCT16: Kymanox Relationships
R E L A T I O N S H I P S
By Nathan Blazei, MEng, ASQ CQA
Senior Manager, Quality + Compliance
As an engineering and compliance service provider in the life science industry, we are tasked with building and maintaining positive relationships every day. Positive relationships take time, commitment, honesty, trust, and openness to build and maintain. They are mutually beneficial, unassuming, and resilient. When relationships are ignored, taken advantage of, de-prioritized, or otherwise suffer, it can have a devastating effect on a business and ultimately the patient communities we all aim to serve.
This may sound intuitive, however there are few industries that have the complexity of relationships that we experience in the life sciences. We work in a field that has many interconnected parts that are sometimes at conflict with one another. The expectations are so incredibly high, and the margin for error is razor thin. Life science companies have to provide mutual benefit to our employees, our investors, our shareholders, our patient communities, our medical professionals, our insurance providers, our business partners, and our governments at the same time. And the goals of each of these stakeholders are not always aligned, which makes the job at hand all the more challenging.
We have seen a prime example of the challenge to building and maintaining positive relationships recently with the EpiPen from Mylan, which is used for emergency treatment of severe allergic reactions. As a parent of a child with a severe peanut allergy, I am obligated to have EpiPens on hand at all times. My son has them at school, we have them at home, and we take them with us everywhere we go. And right now there are few, if any, reliable alternatives to consider. As the EpiPen’s price continues to rise, Mylan runs the risk of not being able to get EpiPens into the hands of those in our community who need them for survival.
Mylan is facing intense public scrutiny because of what could in many ways be traced back to poor relationship management. While the debate continues and the government mulls its options for how to address this situation, one is left to wonder if Mylan lost sight of the goals of some of their stakeholders in favor of those of others. Right or wrong, they are now under the microscope of an entire nation. Where they go from here will have a profound impact on the many relationships they have built over the years. And some will likely never recover.
At Kymanox, we put tremendous value on building and maintaining positive relationships with our employees, our clients, our business partners, our community, our government, and the various patient populations we serve.
We understand the challenge of working in this industry and we know the expectations are always sky high. We embrace that challenge, and we look forward to building and maintaining a positive relationship with all of you in the years to come in order to continue advancing modern medicine together.
07JUL16: Kymanox welcomes Katie Guay, Cristisan de la Cotera, Michael Zaleski
Kymanox is pleased to announce the on-boarding of Katie Guay, Cristisan de la Cotera, and Michael Zaleski! We are so pleased to be growing so Fast! Good luck to all and Welcome Aboard!
16JUN16: Kymanox welcomes Michelle McMahan
Kymanox is pleased to announce the on-boarding of Michelle McMahan for the position of Process Engineer. In the Validation group, she will be ensuring that deliverables continue to exceed client expectations.
16MAY16: Kymanox welcomes Matt Wheeler
Kymanox is pleased to announce the on-boarding of Mr.Matt Wheeler for the position of Validation Scientist. In the Validation group, he will be ensuring that deliverables continue to exceed client expectations.
09FEB16: Kymanox welcomes Nathan Cox
Kymanox is pleased to announce the on-boarding of Mr. Nathan Cox for the position of Huntsville Branch Manager. In the Management group, he will be expanding the Kymanox Presence into Alabama and surrounding areas.
08FEB16: Kymanox welcomes Oksana Samarski
Kymanox is pleased to announce the on-boarding of Oksana Samarski for the position of Project Specialist. In the Process Operations group, she will be ensuring that deliverables continue to exceed client expectations.
28JAN16: Kymanox welcomes Rachel Leahy
Kymanox is pleased to announce the on-boarding of Rachel Leahy for the position of Senior Compliance Scientist. In the Quality + Compliance group, she will be ensuring that deliverables continue to exceed client expectations.
26JAN16: Kymanox welcomes Terry McDonald
Kymanox is pleased to announce the on-boarding of Mr. Terry McDonald for the position of Chicago Branch Manager. In the Management group, he will be maintaining the Kymanox presence in Chicago and surrounding areas.
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22JAN16: Kymanox welcomes Ayman Tamimi
Kymanox is pleased to announce the on-boarding of Mr. Ayman Tamimi for the position of Associate Project Engineer. In the Technical Project Management group, he will be ensuring that deliverables continue to exceed client expectations. Ayman will soon complete his Bachelor of Science degree in Chemical Engineering at North Carolina State University (www.ncsu.org).
28JAN15: Kymanox CEO to speak at ISPE Conference
Kymanox and partner bioMerieux are teaming up to talk about technology transfer at the upcoming ISPE show on 10MAR14 in Raleigh, NC.
The presentation will be part of the “Process Optimization” session, and is entitled, “A Roadmap from Design to Commercialization: Lifecycle Implementation of the Technology Transfer Package”. Presenters include Brooks Taylor, Staff Process Engineer and Tech Transfer Lead at bioMerieux, and Stephen Perry, President & CEO at Kymanox.
The full agenda can be viewed at the following link: http://www.ispe-casa.org/2015/speakers-schedule.aspx
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24JAN15: Kymanox Wants You to Vaccinate!
The recent measles outbreak in the USA did not need to happen.
From Kymanox President & CEO, Stephen M. Perry: “A presentation (click here to view) was put together by my good colleague Dr. Brad Walters nearly 5 years ago. If you have any doubts about vaccines, you need to educate yourself and those around you. Vaccines are not 100% effective in every individual case, but they do work and there is very good science behind them that goes back a millennium. I vaccinate my four children: one shot at a time and when they are not sick; they get the protection they deserve and we also help protect those around them.”
Please take the time to view this presentation and get educated on vaccines. The world is counting on you!
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24MAR14: Kymanox Acquires Freedoms Labs, Inc. and Signs New Director
MaryBeth Panagos joins Kymanox as Partner and Business Development Director
Research Triangle Park, North Carolina, United States | Monday, 24 March 2014 | Kymanox expands its offerings by acquiring Freedom Labs, Inc., and onboarding its CEO as Director of Business Development.
Founded in San Antonio, Texas in 2010, Freedom Labs, Inc. provides a unique and effective platform for education, content delivery, and advocacy. President and CEO, Stephen M. Perry states, “This acquisition adds to our Ideal Knowledge Transfer (IKT) portfolio and opens a new strategic avenue for Kymanox.”
22NOV13: Inaugural Show-and-Tell Networking Event for North Carolina Nanobiotechnology
Kymanox to co-sponsor new networking series offered by the North Carolina Center of Innovation for Nanobiotechnology (NC COIN)
Research Triangle Park, North Carolina, United States | NC COIN members Kymanox and RJ Lee Group are co-sponsoring the first in a series of show-and-tell networking events at the North Carolina Biotechnology Center (NCBC) in RTP on Tuesday, 10 December 2013. These events bring industry, academia, investors, and government professionals together to discuss hot topics impacting this emerging field. Events like this help maintain and improve RTP’s status as a top five nanotech cluster in the United States. The free event kicks off at 5:00 PM and will feature appetizers, drinks, networking sessions, and six brief technical presentations from industry experts.
RTP is home to several nanotechnology companies with biotechnology products in their pipelines, and there is a need for more collaboration to bring these product ideas to commercial reality. Kymanox President and CEO, Stephen M. Perry, is excited to kick off this new event format with NC COIN. “As the first founding member of the new NC COIN organization, we feel compelled to support these programs and know that similar programs have been successful in other leading markets, such as Boston and San Jose,” said Perry. “The networking opportunities will serve a critical role in accelerating product development and commercialization in nanobiotechnology, which will in turn spark business and job growth in the region.”
Nathan Blazei, MEng of Kymanox and Crystal Morrison Densmore, PhD of RJ Lee Group will both present at this event. Opening remarks will be provided by John Hardin, Ph.D, Board Member, NC COIN and Executive Director, Office of Science and Technology for the North Carolina Department of Commerce.
20NOV13: COIN Members Kymanox and RJ Lee Group Host the First Show-and-Tell
Gather for a great RTP networking opportunity. Drinks and appetizers provided. Discuss several hot topics with leading experts and peers.
5:35-5:45 pm – Opening Remarks by John Hardin, Ph.D, Board Member, COIN and Executive Director, North Carolina Board of Science & Technology
5:45-6:00 pm – Presentation chaired by Lin Wu, PhD, Director of Client Interfacing and Business Development, RJ Lee Group
Anti-Counterfeiting – Incorporating overt, covert, and forensic counterfeit deterrence for biopharmaceuticals and medical devices.
Foreign Particulate Matter Investigations – Using proactive and QbD-aligned approaches to investigate, resolve and prevent contamination issues with highlights from training provided to the FDA.
Materials Lifecycle Management – Keeping the end in mind: using lifecycle management to expedite materials assessment (e.g., plastics, metals, nanomaterials), commercialization, and risk mitigation.
6:00-6:15 pm – Presentation chaired by Stephen M. Perry, ChemE, PMP, President & CEO, Kymanox
Real Risk Management – In all phases of the drug development process, (actually) follow streamlined and compliant practices for risk management and ensure risks are identified, documented, and actively monitored. “Make it real.”
Project Portfolio Management – Define and prioritize your entire operational organization by the project work that it is already performing and control using dashboard concepts. “Projectize your company.”
CGXP Documentation for FDA – Have the discipline and foresight to collect, analyze, and report data at all phases so it can be leveraged for eventual regulatory approval. “Documents are monuments.”
6:15-7:00 pm – Q&A and Additional Networking
For more information and to RSVP for this FREE event on 10DEC2013, contact:
Ms. Heema Sinanan
Business Development Specialist
North Carolina Center of Innovation for Nanobiotechnology (COIN)
Email firstname.lastname@example.org | Work 336-217-5187 | Mobile 516-417-2868
26SEP13: Kymanox Expands Staff, Adapts to Diversifying Client Base
Nathan Blazei joins Kymanox as new Senior Technical Project Manager
Research Triangle Park, North Carolina, United States | Kymanox expands its RTP staff by hiring a highly experienced engineer and project manager.
Blazei is a welcome addition to the Kymanox team, CEO and President Stephen M. Perry remarked. “Nathan comes from the same Notre Dame program that produces well-rounded, big-picture professionals who can relate to people and not just science,” he said. “This perspective will make the Kymanox team even more adaptable and valuable to our expanding client base.”
05SEP13: Kymanox Employees Certified for Project Management
Elizabeth Lutton becomes most recent employee to pass exam
Research Triangle Park, North Carolina, United States | A growing number of employees at Kymanox are certified with professional accreditation in project management.
Kymanox is one of the select companies that encourage seasonal student employees to take project management classes and the CAPM exam as part of its internship and cooperative student programs. These programs are now in their eighth year.
Lutton credits Kymanox for her success. “When I decided I wanted to attempt to take the CAPM exam, I received nothing but support from Kymanox,” she said. “I was provided with every resource I could have ever needed, and everyone was willing to help.”
Lutton joins four others at Kymanox – Jie Shen, CAPM; Daniel Ryan, MEM, CAPM; Jessica Liu, MEM, CAPM; and Kevin Brown, PMP – who have also passed their PMI certification exams in the past year. To support its employees, Kymanox covers all expenses for the extensive training and cost of the exam.
CEO and President Stephen M. Perry emphasized the importance of having a solid foundation in project management. “It’s really a life skill that everyone should have; I got my PMP certification when Kymanox was first founded and I still put those skills to use each and every day,” he said. “We build on the foundation PMI gives us and create our own brand of execution-focused and results-driven project management.”
Kymanox further pays for and requires select operations personnel to take either the CAPM or Project Management Professional (PMP) exams within their first year of employment.
16AUG13: Kymanox Contends at PDA Midwest Chapter 9th Annual Golf Outing
Left to Right: Kymanox team members Bill Giardina (Abbott Alumnus), Kenneth Knox (Abbott Alumnus), Matthew Perry (Abbott/Baxter Alumnus), and Don Freymann (Loras College Alumnus) pose on the first tee.
Kymanox was once again a participant in this year’s PDA Midwest Chapter 9th Annual Golf Outing.
The company was a sponsor for the golf luncheon and an exhibitor at the event. The Kymanox team came in at 5 under par for the day, not far behind the tournament winners. In addition, Bill Giardina won both closest-to-the-pin challenges on the 18-hole, Par 72 course at Chevy Chase Country Club in Wheeling, Illinois.
Kymanox looks forward to defending its previous titles next year, when the 10th annual outing will coincide with the company’s 10th anniversary.
The company would like to thank PDA, the Midwest Chapter and all event coordinators.
24JUL13: Kymanox Continues Expansion in North Carolina
Three new hires join the RTP office
Research Triangle Park, North Carolina, United States | Kymanox has filled three new positions at its offices in the Research Triangle Park.
North Carolina, as detailed in the January 2013 Battelle Report highlighting the impact of bioscience in the state, has the highest bio-based employment growth in the United States. This employment growth is significantly concentrated in the RTP region.
“Kymanox is proud to be an active participant in the RTP economic ecosystem; we are mindful that our role in the community involves adding high-paying jobs that include very specialized training,” Kymanox President and CEO Stephen M. Perry stated.
19JUL13: Kymanox Awards the 2013 James J. Davis Memorial Scholarship to Wendy Cartagena-Gonzalez
Scholarship winner to spend the summer in Brazil to study Afro-Brazilian culture and the problems of racism
“By blogging open-mindedly about the experiences and Brazilian traditions I will encounter, I hope to raise awareness about the cultural diversity that exists in our world,” Ms. Cartagena-Gonzalez wrote in her application essay. “Most importantly I hope my blog motivates more students to take part in immersive cultural programs abroad that will enhance their knowledge about the world we live in and share with others.”
Chairman of the Board and Owner of Kymanox, Sarah J. Perry, noted that it was difficult to choose a single applicant in this year’s talented pool, but that Ms. Cartagena-Gonzalez was ultimately the best fit for the scholarship. “We at Kymanox are so proud to partner with Wendy as she travels to Brazil,” she said. “Study abroad is Ideal Knowledge Transfer at its best and we feel lucky to be involved with it in our small way. We wish every student studying abroad an exciting and educational year!”
The James J. Davis Memorial Scholarship for Students Studying Abroad was established in honor of James J. Davis, a friend and colleague of Kymanox founder Stephen M. Perry. The scholarship awards $1,000 to offset educational expenses and affords recipients to have a more enriched abroad experience.
17JUL13: Kymanox Sustainability Management Earns National Recognition
Kymanox client Highland Park was one of only 12 communities recognized nationwide at the 2013 U.S. Conference of Mayors Annual Meeting
Details of Highland Park’s nomination are available at the U.S. Conference of Mayors website.
For further details on Highland Park’s sustainability initiatives, please visit the City of Highland Park’s official website.
25APR13: Deerfield considers electric car charging stations
Visit the Chicago Tribune website to read the full article.
22APR13: Kymanox and Pharmagen to Present Strategic Vision for Solving Nation’s Parenteral Drug Shortage Crisis at 2013 BIO International Convention
Visit the Wall Street Journal website to read the full article.
21MAR13: Kymanox Collaborates with Duke University to Host Entrepreneurial Contest
Durham, NC, USA | Kymanox launches Entrepreneurial Contest with Duke University to search for talented individuals to lead, manage, and grow one or more Kymanox product lines. The Kymanox products included in this contest are:
KymaSTORE™ – a product that provides “Ideal Knowledge Transfer” in the form of downloadable templates, training packages, and standard operating procedures.
KymaPRO™ – an online database for the compilation and storage of all the important documents associated with a project.
This contest is open to all Duke University graduates or students from the Professional Masters Program. Applicants are required to submit a current resume and a 5 to 10 minute You Tube video link to email@example.com detailing:
- Key and relevant entrepreneurial strengths.
- Identify which products interest them to lead and manage.
- How they plan to grow the product line(s).
- Why the applicant should be selected.
Kymanox will hold a face-toface Q&A session with interested candidates on 05APR13 at 3-4 pm ET on Duke campus. All resume and You Tube videos must be submitted by 22APR13. The contest finalists will be announced on 25APR13. Finalists need to be available for face-to-face interviews with Kymanox’s President and CEO, Stephen Perry, between 26APR13 and 03MAY13. The contest winner(s) will be announced on 06MAY13.
19MAR13: Kymanox Sponsors NC BIO’s Legislative Breakfast
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19JAN13: Kymanox Chairman, Owner, and Operator, Sarah J. Perry, President and CEO, Stephen M. Perry, and Board member, Brad Peganoff attended the 2013 NC Inaugural Ball.
19SEP12: Kymanox Attends NC BIO Bio Manufacturing Forum on Kenan Fellows Program and GEM
Left to Right: Susan Parry (Kenan Institute), Aeona Magliola (Biogen Idec), Julie-Anne Thomasch, Mike McBrierty (Biogen Idec)
Durham, NC, USA | NC BIO hosted a fantastic program addressing important feeder systems for the biotech industry. Ruben Carbonell (NSCU’s BTEC and Kenan Institute) opened the night by introducing the audience to a recent Kenan Fellows award recipient. Julie-Anne, a high school biology teacher, earned a 5-week intensive externship at Biogen Idec and was supervised by the program administrator, Mike McBrierty (Senior Manager, Public Affairs, Biogen Idec) and program mentor, Aeona Magliola (Associated Scientist III, Analytical Development, Biogen Idec). The Kenan Fellows Program finds North Carolina’s top teachers and gives them real-world experience outside of the classroom so that they can enhance their circululums and get students interested and excited about high-tech careers, including biotech. Another program, called GEM, partners companies and universities to find and develop top minority talent that otherwise would not be accessible or affordable. You can learn more at http://kenanfellows.org/ and http://www.gemfellowship.org/.
05SEP12: Kymanox Announces 2012 James J. Davis Memorial Scholarship Winner
Bryan D. Belliard awarded 7th annual James J. Davis Memorial Scholarship.
Durham, NC, USA | Kymanox is pleased to announce the recipient of the 7th annual James J. Davis Memorial Scholarship for Students Studying Abroad. The goal of the scholarship program is to continue the legacy of Jim Davis and help students grow their knowledge of the world to make it a better place. It is open to all full-time undergraduate students at accredited United States institutions who are planning to study abroad. This year’s $1,000.00 award goes to Bryan D. Belliard, a Chemical Engineering major from Worcester Polytechnic Institute (WPI).
To be considered for this scholarship, students were asked to write an original essay presenting what they hope to gain by studying abroad. Selected scholarship finalists were recognized on the Kymanox website and contacted for phone interviews. Numerous applications were received and Kymanox recognizes and congratulates all of the applicants on their academic achievements and ambitions.
Belliard impressed Kymanox with his qualifications and reasons for studying abroad. Belliard will participate in WPI’s Interactive Qualifying Project based in Bangkok, Thailand. Each year, the WPI team is tasked with a new problem to solve. This problem is determined by the most urgent needs of the host site and the strengths of the selected team. It always has a combined engineering and humanitarian focus. Previous projects have included finding ways to protect rice pickers in rural Thailand from insect borne illnesses and finding a sustainable way to maintain elephants’ important role in Thai society. Belliard’s enthusiasm for his upcoming adventure and his drive to make a difference in the lives of everyday people will represent the United States well.
Kymanox Scholarship Administrator, Sarah Perry, says, “It was an honor and pleasure to speak with each and every one of the finalists. I truly enjoyed our conversations and getting to know them each just a little bit. I know they will all have wonderful years abroad and will be great ambassadors to the countries they will be visiting.”
31AUG12: Kymanox to Present at Joint School of Nanoscience and Nanoengineering (JSNN)
Greensboro, NC, USA | Ravi Mulukutla, Senior Manager of Nanotechnology Commercialization at Kymanox, is presenting to staff and students today at the Joint School of Nanoscience and Nanoengineering (JSNN) located in Greensboro, North Carolina. The title of Mr. Mulukutla’s talk is “NanoScience and Technology – Case Studies on Research to Commercialization.” Mr. Mulukutla has coveted experience in taking products from the lab to the marketplace and has worked closely with leading nanotechnology organizations in Japan, United States, Canada, and India.
27AUG12: Kymanox Hires Duke MEM Graduates to Fill Engineering Positions in RTP and Chicago Divisions
Daniel Ryan (ChBE), Mitchel Kevern (ChE), and Jessica Liu (BME) have joined the Kymanox team in North Carolina and Illinois.
Durham, NC, USA | Kymanox is pleased to announce the permanent, full-time placement of Daniel Ryan for the position of RTP Project Engineer, Mitchel Kevern for the position of RTP Process Engineer, and Jessica Liu for the position of Chicago Project Engineer. These highly educated individuals have each earned their Master of Engineering Management (MEM) from Duke University and bring a wealth of talent to Kymanox.
Mr. Ryan has spent time working with supply chains for pharmaceutical companies, quality control in chemical production, and polymer research for the batteries in the automotive industry.
Mr. Kevern has worked with medical device companies to create strategic product development plans and in quality control environments to generate new analytical testing protocols.
Ms. Liu has conducted biomedical research in both university and hospital laboratories and has provided commercialization assessments for both startups and established organizations.
Kymanox President and CEO, Stephen M. Perry, says, “We are excited to make these important additions to our team and to continue our trend this year of hiring one person per month. We are committed to rapidly developing our entry-level resources into senior-type contributors. Duke has been a great partner for us; they are attracting top-notch individuals into their MEM program and have an ideal rubric for ensuring workplace success.”
21AUG12: Kymanox Meets with Maryland Comptroller at MACo
Left: Stephen Perry, President & CEO, Kymanox
Middle: Peter Franchot, Comptroller, State of Maryland
Right: Brad Peganoff, Vice President, Government & Corporate Relations, RTI
Ocean City, MD, USA | Kymanox board members Stephen Perry and Brad Peganoff met with Peter Franchot, the Comptroller of Maryland, at his MACo fundraiser event. Mr. Franchot gave an energizing speech on what the State of Maryland needs to do to excel – including providing more help for businesses that take risks to grow and hire employees. Mr. Franchot, like Kymanox, emphasizes the value of “transparency” to enable the best possible decision making. Mr. Franchot serves on the Maryland Board of Public Works that oversees State-issued contracts and is a likely candidate for 2014 Governor’s race. Visit http://www.marylandtaxes.com/ to learn more about what the Comptroller is actively doing to help the citizens of Maryland.
20AUG12: Kymanox Wins Golf Tournament
Chevy Chase Country Club, Wheeling, IL, USA | Left to right: Matt Perry, Stephen Perry, Stan Walczynksi, and Thom Culkar from the Kymanox Midwest office won the 8th Annual PDA Midwest Golf Outing for recreational players. A big thanks goes out to Sarah Patrick, from Baxter, and all the organizers for this important and entertaining networking event. This year’s sponsors included Maetrics, CVCT, Hach, Aramark Cleanroom Services, Kymanox, Middough, and Ellab Thermal Validation Solutions. Kymanox looks forward to participating and sponsoring again next year.
15AUG12: Kymanox Attending Nanomanufacturing Conference in Greensboro, NC
Durham, NC, USA | The Kymanox NANO COMMERCIALIZATION team – including one of our distinguished Board Members – is at the Nanomanufacturing Conference today in Greensboro, North Carolina. Best wishes everyone!
Left to right: Kymanox’s Mitchel Kevern, Sita Lakkaraju, Joe Magno (board member), and Ravi Mulukutla
20JUL12: Kymanox Sponsors PDA 8th Annual Golf Outing in Wheeling, IL
Durham, NC, USA | On Friday, August 10, 2012, Kymanox is again sponsoring PDA Midwest Chapter’s 8th Annual Golf Outing in the Chicago area. This is a great way to network with other individuals from the industry and have fun at the same time.
Chevy Chase Country Club
1000 N. Milwaukee Avenue
Wheeling, IL 60090
$75 per person for PDA members
$85 per person for non-PDA members
2 Free Drink tickets
Beer, brats, and chips
Prizes, Hors d’oeuvres and raffle after golf
Visit PDA Midwest Chapter’s official website for more details. We look forward to seeing you there!
26APR12: Kymanox Presenting for KU Bioscience Continuing Education
Durham, NC, USA | On May 3-4, 2012, Kymanox is presenting the “Universal Technology Transfer Methodologies For the Bioscience Industry” at the Kansas Bioscience Authority (KBA), 10900 S. Clay Blair Blvd., Olathe, Kansas.
This extensive two day program is designed for professionals in the life science industry who need to transfer knowledge, a process and/or product operation from one location to another.
The course will be presented by Stephen Perry, President & CEO of Kymanox.
For more information on the course, please visit the KU Bioscience Continuing Education page.
14MAR12: Kymanox Sponsors NC BIO Forum in RTP, NC
Left: Stephen Perry, Kymanox, addressing the forum audience.
Middle: Stephen Perry, Kymanox, addressing QA/RA professionals from Targacept.
Right:Kymanox’s Stephen Perry, Jie Shen, Sita Lakkaraju, with Jennifer (Fong) Malloy from NC BIO.
Durham, NC, USA | Kymanox was one of the key sponsors today at a special NC BIO forum at the North Carolina Biotechnology Center. Many of the top quality and regulatory (QA/RA) professionals in the region were in attendance. Mr. Andrew Emmett provided an update on PDUFA V reauthorization which is due for congressional approval prior to PDUFA IV’s expiration later this summer. Several enhancements are slated for PDUFA V which are designed to improve the FDA’s overall performance in reviewing and approving new drug and biologic applications. Currently, priority applications are taking 9 months to review while standard applications take 13 months; overall, only 1 out of every 3 applications is approved in the first review-and-approval cycle. Kymanox works to stay current on all legislative changes related to FDA so that we can provide the very best recommendations to our clients.
05MAR12: Kymanox Sponsoring new RTP Networking Event
Durham, NC, USA | Kymanox will sponsor the first annual “Bio On Tap” event at Serena Restaurant on March 20, 2012 from 5:30 – 7:00. Kymanox is excited to work with COIN once again as they create a new networking event specifically tailored for the Nano/Bio community in the Research Triangle.
17FEB12: Kymanox Expanding in RTP
Durham, NC, USA | Kymanox has three new openings in RTP for permanent, full-time employment. The positions are Executive Assistant to the CEO, Marketing and Communications Specialist, and RTP Operations Manager. Three divisions of Kymanox are now located in RTP including RTP Regional Service Operations, Corporate Operations, and Product Operations. Although Kymanox is still headquartered in Chicagoland, many of the company’s core business operations are moving to North Carolina. The State of North Carolina has been extremely helpful as well as supporting organizations in the RTP ecosystem such as CED, NC BIO, NCBC, and COIN.
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01FEB12: Kymanox Hires Vice President for Chicago Division
Engineering and management professional, Stan Walczynski (P.E./MBA), has joined the Kymanox Team in Chicago.
Gurnee, IL, USA | Kymanox is pleased to announce the hire of Stan Walczynski, P.E., MBA for the position of Vice President of Operations for the Chicago Division. Mr. Walczynski brings twenty-plus years of experience in engineering, regulatory compliance, chemical operations, and large-scale project management. At both large and small companies, he has gained broad experience in a variety of functional areas including management, engineering, process development, plant operations, and commercialization. Mr. Walczynski received a Master’s in Business Administration from the University of Chicago, as well as a Bachelor’s of Science in Engineering from Bradley University. He is also a licensed Professional Engineer in several Midwestern states.
Kymanox President & CEO, Stephen M. Perry, says, “Stan’s in-depth technical and business background – along with his honest character – is a perfect match for both Kymanox and our clientele. We are also fortunate to have Mr. Walczynski as a member of our management team.”
09NOV11: Kymanox Cooperative Student Wins Co-Op Student of the Year at Northwestern University
Kymanox Project Specialist, Megan Dunham (CAPM Certified), has been selected as Northwestern University’s Co-Op Student of the Year.
Gurnee, IL., USA | Kymanox is pleased to announce that Megan Dunham has been selected as the 2011-12 Walter P. Murphy Cooperative Engineering Education Student of the Year winner. Dunham has been a Co-Op for Kymanox since March 2010 and has been a key member of the Kymanox team for the last year and a half. Throughout her time as a Project Specialist at Kymanox, Dunham has served in many roles. She acted as the primary on-site representative for Kymanox’s second largest client in the Midwest region. She was a member of a four person team responsible for a re-validation program at an aseptic, liquid-fill facility. Dunham also led the Kymanox New Employee Task Force and maintained a Sales and Marketing role at the 2010 and 2011 national BIO conferences in Chicago and Washington, D.C.
As Northwestern University’s winner, Dunham will now be nominated for Co-Op Student of the Year in national competitions sponsored by The Cooperative and Experiential Education Division (CEED) of the American Society of Engineering Education (ASEE) and The Cooperative Education and Internship Association, Inc. (CEIA). Dunham is scheduled to graduate in the Spring of 2012 with a Bachelor’s of Science degree in Chemical Engineering.
Supervisor and Kymanox Technical Project Manager, Megan Gladfelter, says, “Megan has far exceeded our expectations for a Co-Op student with her exceptional quality of work, initiative to learn, and ability to adapt to challenging environments. She has reset the bar for future Kymanox Co-Ops and is well deserving of this award.” President and CEO, Stephen M. Perry, states, “It is fitting to have Ms. Dunham be recognized for this award. We are proud that our six-year old program has evolved to the point where it can support and elevate talented individuals such as Ms. Dunham. Furthermore, we hope this recognition will help us to continue attracting top talent each year for the two openings in all of our regional offices.”
22SEP11: Kymanox joins the North Carolina Biosciences Organization (NC BIO)
Durham, NC, USA | Kymanox is pleased to announce its acceptance as a core member of the North Carolina Biosciences Organization.
The North Carolina Biosciences Organization (NCBIO) is the trade association for North Carolina’s life science community. As a statewide nonprofit advocacy organization, NCBIO works with federal, state and local officials to improve North Carolina’s attractiveness as a location for life science discovery, innovation and commercialization.
NCBIO also provides a variety of membership benefits designed to directly support the growth of its member companies and institutions, which are part of the nation’s third largest state biotechnology cluster. NCBIO’s members include companies and institutions from all sectors of North Carolina’s life science industry.
Visit the NC BIO website for more details.
19SEP11: Kymanox sponsors 2011 PDA/FDA Conference
Rockville, MD, USA | Kymanox is pleased to announce its sponsorship of the FDA/PDA conference held from Monday, September 19 through Friday, September 22, 2011.
The PDA/FDA Joint Regulatory Conference & TRI Courses offers the unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.
NCBIO also provides a variety of membership benefits designed to directly support the growth of its member companies and institutions, which are part of the nation’s third largest state biotechnology cluster. NCBIO’s members include companies and institutions from all sectors of North Carolina’s life science industry.
Visit the PDA website for more details.
23AUG11: Kymanox releases Computer System Validation Turnkey Solutions
Gurnee, IL., USA | Kymanox is pleased to announce the release of its Turnkey Computer System Validation Suites on KymaSTORE™ (www.kymastore.com). With solutions for both Pharma/Biotech and Medical Devices, Kymanox has succeeded in creating an industry platform for easily implementing regulatory compliant documentation for computer systems and software.
The new Turnkey Computer System Validation Suites provide a detailed outline of how to validate a computer system in a GxP regulated environment. A roadmap for which documents must be included, as well as topics that need to be addressed in each document, are covered in detail.
“We are especially excited to offer a solution to Medical Device companies who struggle to deal with the fact that the CDRH branch of FDA does not recognize GAMP®” says Stephen M. Perry, President and CEO of Kymanox.
03JUN11: Kymanox joins Illinois Biotechnology Industry Organization (iBIO)
Gurnee, IL, USA | Today Kymanox joined the Illinois Biotechnology Industry Organization (iBIO). iBIO is a life sciences industry association dedicated to advocating for sound public policy, as well as creating a strong sense of community among the public, private, and academic sectors, and promoting development and retention of new companies and corporate expansions in Illinois. As a growing contract service provider in the biotechnology, pharmaceutical, and medical device industries, Kymanox is excited to be a member of iBIO.
02MAY11: Kymanox to attend BIO Legislative Day Fly-In May 3-4, 2011 in Washington, DC.
Durham, NC, USA | Stephen Perry of Kymanox will attend the Legislative Day Fly-In May 3-4, in Washington, DC.
The two day conference provides industry executives with the chance to meet with the Members of the 112th Congress and to advocate for the BIO legislative agenda. Stephen will be meeting with distinguished congressional representatives from North Carolina, Illinois, and Maryland at the event.
28APR11: Stephen Perry of Kymanox, attends NC Legislative Breakfast
Durham, NC, USA | Stephen Perry of Kymanox attended the NCBIO legislative breakfast held today at the legislative building in downtown Raleigh.
Two of Kymanox’s preferred partners, RTI International and NC COIN (Center of Innovation for Nanobiotechnology), were in attendance. RTI was the primary sponsor for the event. Also, Stephen was able to meet with North Carolina congressmen and prestigious biotechnology business leaders from companies like FujiFilm Diosynth Biotechnolgy, Novozymes, Novartis, and GlaxoSmithKline.
29MAR11: Kymanox launches Preferred Partner Network (KPPN)
Durham, NC, USA | Kymanox announced today the creation of the Kymanox Preferred Partner Network (KPPN). Leveraging its process expertise and access to developed clientele, Kymanox is formalizing a network of preferred partners to enhance supplier and vendor success.
The network facilitates access to the very best products and services in the biotech, pharma, and medical device industries, and is a win-win for partners and end-clients.
24MAR11: Kymanox to Sponsor and Judge the UIC 2011 Engineering Expo
Gurnee, IL, USA | Kymanox is pleased to announce that Justin Pawlik, VP of Midwest Operations at Kymanox, was asked to be a judge at the University of Illinois at Chicago’s Engineering Design Expo on April 26, 2011. Kymanox will also be a sponsor of the event.
The expo showcases the design projects for potential 2011 graduates in the College of Engineering and attracts the attention of companies in the Chicagoland area looking to attract and hire top talent, support the community, and network with students and other executives. Kymanox is pleased to be a part of this event. Visit the Expo 2011 page for more information.
22MAR11: Kymanox Hires Vice President for DC Division
Washington, D.C., USA | Kymanox is pleased to announce the hire of Colleen Sico for the position of Vice President of Operations for the Washington, D.C. division. Ms. Sico brings fifteen years of experience in the biotechnology and vaccines industry. At both large and small biopharmaceutical companies, she has gained broad experience in a variety of functional areas including process development, pilot plant operations, and commercial manufacturing. Ms. Sico completed a Master’s in Business Administration at Johns Hopkins University as well as a Bachelor’s of Science in Chemical Engineering at the University of Maryland Baltimore County.
Kymanox President, Stephen M. Perry, says, “Colleen’s technical background, communication skills, and business acumen will be of great service to our clients in the greater DC area. We are very pleased to have her as a member of our management team. Kymanox is committed to providing world-class, local-based services and will leverage Colleen’s previous participation and leadership in this local and thriving biotech community.”
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16FEB11: Kymanox sponsors “Open Innovation Bullpen” at Center of Innovation for Nanobiotechnology (COIN).
Research Triangle Park, NC, USA | Kymanox announced today that it will sponsor the “open innovation bullpen” at the Center of Innovation for Nanobiotechnology (COIN). The bullpen is a place within the center where COIN’s team of interns, contractors, visiting partners and members can congregate to collaborate and work to build the nanobiotechnology hub.
Kymanox will be present at the next COIN event, the COIN Open House, to be held on March 8, 2011, from 5PM-7PM. Visit COIN’s roundtable series page to RSVP to this free event.
Kymanox was also recently mentioned in the Tech Journal South with regard to this sponsorship. It can be seen online here.
22OCT10: Kymanox Announces 6th Annual James J. Davis Memorial Scholarship
Gurnee, IL., USA | Kymanox is pleased to announce its sixth offering of the James J. Davis Memorial Scholarship for Students Studying Abroad. Over the past five years, the scholarship has attracted applications from a large and diverse pool of highly qualified students planning to study abroad. It has continually received growing interest each year.
The 2011/2012 scholarship is open to all US undergraduate students studying abroad through accredited US colleges or universities. The selected recipient will receive $1000.00 (US) for 2011/2012 educational-related expenses. More details and the scholarship application can be found on-line at: www.kymanox.com/scholarship.
“Kymanox is happy to invest in such promising students and proud to honor the memory of James J. Davis in this way,” says Kymanox President, Stephen M. Perry, PMP.
Founded in 2004, Kymanox is focused on facilitating effective and efficient knowledge transfer. The name Kymanox was derived from Greek and means Ideal Knowledge Transfer™. The company specializes in technical project management and engineering services within the Life Sciences industry. Learn more by visiting www.kymanox.com.
13OCT10: Kymanox Hires Project Specialist for RTP Division
Durham, NC, USA | Kymanox is pleased to announce the hire of Jie Shen for the position of Project Specialist in our Research Triangle Park (RTP) office. Ms. Shen completed a degree in Mathematical Decision Science with a concentration in Statistics at the University of North Carolina at Chapel Hill and has studied Operational Research at the graduate level. She is fluent in written and spoken Mandarin Chinese and highly proficient in Japanese.
Kymanox President, Stephen M. Perry, says, “We are all excited to have Ms. Shen on board. In her short time with us, she has shown excellent leadership aptitude and a strong work ethic. Her analytical, organizational, and problem-solving skills have already been put to good use.”
Kymanox will expose Ms. Shen to Industry Standards, Professional Project Management, Biopharmaceutical Manufacturing, Good Manufacturing Practices, Good Documentation Practices, Validation, GMP Statistics, Sales, Customer Service, and Product Management as part of her intensive rotational development program.
06OCT10: Kymanox provides input on new “Corynex” expression system technology
Research Triangle Park, NC, USA | Kymanox’s Vladimir Kostyukovsky, PhD and Senior Technical Manager, was quoted recently in literature on the Drug Discovery and Development website for the new Corynex expression system technology created by Ajinomoto.
24AUG10: Kymanox visits Joint School of Nanoscience and Nanoengineering (JSNN).
Research Triangle Park, NC, USA | On Tuesday, August 24, Stephen Perry and Joe Magno of Kymanox met with James G. Ryan, PhD, Founding Dean of the Joint School of Nanoscience and Nanoengineering (JSNN) in conjunction with senior leadership from the M+W Group. Dr. Ryan gave a tour of JSNN’s existing facility and offered a first-hand look at their current expansion project, which is a state-of-the-art nanotechnology development and manufacturing center. JSNN has a wide array of nano research and testing equipment, including one of only a handful of helium ion microscopes in the world. This microscope is capable of viewing single atoms – as shown on the left screen in the photo below. A nanostructure is visible on the right screen.
Kymanox believes nanoscience is a key enabling technology and will play an increasingly important role in the development and manufacturing of biotech, pharma, and medical device products. JSNN’s facility and faculty provide a unique resource to the community as well as to Kymanox and its clients.
23AUG10: Kymanox exhibits at BioJapan.
Research Triangle Park, NC, USA | Kymanox exhibited at BioJapan from 29SEP10 through 01OCT10 in Yokohama, Japan. According to Joseph Conaty, Business Development Manager at the North Carolina Department of Commerce (NC-DOC), this is one of Japan’s leading life science exhibitions and conferences; though not affiliated with BIO (www.bio.org), it replicates a similar atmosphere as the BIO show as it combines a trade show hall, scientific conference, and business partnering forum into one.
Kymanox was at the North Carolina (USA) booth in coordination with the North Carolina Department of Commerce. “I am very excited to have this opportunity for Kymanox to exhibit in Japan,” says Stephen M. Perry, President of Kymanox. “We have an excellent Japanese customer base and value many of the same things that are important to our Japanese clients.”
15JUN10: Kymanox sponsors “Personalized Medicine in the 21st Century” conference.
Research Triangle Park, NC, USA | Kymanox is proud to have been a sponsor for the conference entitled “Personalized Medicine in the 21st Century.” Speakers included one of the “founding fathers” of modern biotechnology, G. Steven Burrill, and distinguished representatives from FDA and around the world. The conference was presented by RTI International and the North Carolina Biotechnology Center. Stephen M. Perry, President of Kymanox, attended.
24MAY10: Kymanox moves Midwest Office to Gurnee, IL
Gurnee, IL, USA | In order to support our expanding business, Kymanox’s legal headquarters and Midwest office location has moved from Highland Park, Illinois to Gurnee, Illinois. Our new address for all legal matters, accounting, and Midwest office communication is as follows:
Kymanox Midwest Office (Gurnee, IL)
1800 Nations Drive
Gurnee, IL 60031
New Office Phone: 224-538-3810
The new office is located near the Grand Avenue (Route 132) exit on the I-94 Tri-State Tollway in the general vicinity of Gurnee Mills Shopping Center and Six Flags Great America. We are about a 40-minute drive from O’Hare International Airport (ORD).
03MAY10: Kymanox exhibits at BIO as “CMOLocator by Kymanox”
Chicago, IL, USA | Kymanox exhibited at the BIO International Conference in Chicago, IL this week. We had a great turnout at the booth, and we were very happy to meet the hundreds of people who stopped by. Kymanox is proud to introduce CMOLocator, our Biopharma Contract Manufacturing Search Engine, at this conference.
01APR10: Kymanox welcomes 2 new employees to our team
Research Triangle Park, NC, USA | Kymanox is happy to announce the hiring of three new employees in the first quarter of 2010:
- Sarah Perry joins us as our new Customer Service coordinator. Sarah has over 10 years in the customer service and sales, with key roles in both large and small businesses.
- Megan Dunham joins us as a Project Specialist from Northwestern University in Evanston, Illinois.
23MAR10: Kymanox exhibits at ISPE/CASA Event in Raleigh, NC
Research Triangle Park, NC, USA | Kymanox exhibited today at ISPE-CASA in Raleigh, NC, for the third consecutive year. In attendance from Kymanox were Stephen Perry (President), Maria Kostyukovskaya (Process Operations Scientist), Joe Magno (Strategic Business Advisor), and Sarah Perry (Customer Service). To those we met, thank you for stopping by!
18MAR10: Course attendees rate “Universal Technology Transfer Methodologies for Biopharmaceuticals” course as 4.6 out of 5.0
Research Triangle Park, NC, USA | Kymanox is happy to announce that our most recent course offering at BTEC, “Universal Technology Transfer Methodologies for Biopharmaceuticals” on March 15-16 was rated a combined 4.6 out of 5.0 by the course attendees. Some comments of the course attendees included:
“I most enjoyed the industry expertise of the instructors.”
“I very much enjoyed the anecdotes of real situations. They were very instructive and hit close to home.”
“The Presentations were clear and simple to follow.”
“The case study discussions and integration of all material presented was the best part of the course.”
Thanks to all who attended the course and helped to make it such a success.
16MAR10: CMOLocator surpasses 50 Active Partner Biopharma CMOs
Research Triangle Park, NC, USA | Kymanox is proud to note that our free Biopharma CMO Search Engine, CMOLocator, now provides access to production line information for over 240 production lines at over 50 of the best Biopharma Contract Manufacturing Organizations (CMOs) from around the world. Visit CMOLocator.com for more information. See our entire list of Biopharma CMOs.
01MAR10: Kymanox announces formal business agreement with Joe Magno
Research Triangle Park, NC, USA | Kymanox announced a formal business agreement with Joe Magno of Joseph L. Magno, LLC. Mr. Magno will be providing Kymanox with Strategic Business Advisement services.
20FEB10: Stephen Perry of Kymanox Attends CED Biotech Conference, February 22-23
Research Triangle Park, NC, USA | Stephen Perry, President of Kymanox, attended the CED Biotech Conference in Raleigh, NC on February 22-23. Visit the CED Biotech Conference page for more information.
08FEB10: Kymanox releases new version of Website
Research Triangle Park, NC, USA | Kymanox released version 4.0 of their website today. New features include improved navigation and “Web 2.0” look and feel.
12JAN10: Stephen Perry, President of Kymanox, published in Pharmaceutical Manufacturing
Research Triangle Park, NC, USA | Stephen Perry, President of Kymanox, wrote the cover story for the January edition of Pharmaceutical Manufacturing.
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01JAN10: Happy New Year from Kymanox
Research Triangle Park, NC, USA | Kymanox, LLC wishes you a happy 2010 and is very excited about the new year, and new decade!
06NOV09: Kymanox Announces Official Release of CMOLocator.com
Research Triangle Park, NC, USA | Kymanox, LLC is pleased to announce CMOLocator.com is now live. CMOLocator.com is a free search engine to find biopharmaceutical Contract Manufacturing Organizations (CMOs).
The database, which is growing daily, currently has over 125 production lines with capability, capacity and availability information. Searches are conducted by selecting any number of criteria such as Drug Substance, Drug Product, Mammalian Cell Culture, and/or Microbial Fermentation. The user can also select the size of the required reactor and the clinical stage of the product. A number of other technical service offerings, such as Cell Line Development or Formulation Development, can be selected to further narrow searches. Organizations looking to outsource their manufacturing can spend a lot less time and money searching for possible CMOs.
According to Stephen Perry, President of Kymanox, “CMOLocator is a paradigm shift in providing and organizing the information related to biopharma CMOs. CMOs can take control of and maintain their own data to ensure its accuracy, and users can get search results easily and immediately without having to register or provide any personal information. Best of all, it’s free for both the CMOs and the users of the search engine.”
CMOs can also elect to be a site sponsor and receive additional benefits from CMOLocator. Any product or service providers may also purchase advertising space on the site. Please see the full-page feature on CMOLocator in the December 2009 issue of Biopharm International’s Corporate Capabilities issue. CMOLocator will also be exhibiting at the BIO 2010 Conference in Chicago, Illinois, 03-06 May 2009.
06NOV09: Kymanox Sponsors George Watts Hill Alumni Event
Research Triangle Park, NC, USA | Kymanox will sponsor a George Watts Hill Alumni Event on Friday, November 6, 2009 at 5;00PM at the Carolina Ale House in Brier Creek, NC.
Former colleagues from the George Watts Hill location of Corning Bio / Covance / Diosynth / Schering-Plough are invited to join their colleagues, old and new, for this reunion get-together sponsored by Kymanox.
15OCT09: Kymanox Co-Sponsors Notre Dame Lecture & Facility Tour Series at Asahi-Kasei TechniKrom.
Glenview, IL, NC, USA | Kymanox co-sponsored a Notre Dame Lecture & Facility Tour at Asahi-Kasei TechniKrom on Tuesday, October 6, 2009.
The lecture was entitled “Nanosensor Technology at Notre Dame” and was presented by Paul Bohn (ND BS ’77), Schmitt Professor of Chemical Engineering.
18MAY09: Kymanox to Attend BIO 2009 on Tuesday, 19MAY09.
Raleigh, NC, USA | Stephen Perry, Justin Pawlik and Vladimir Kostyukovsky will be attending the BIO 2009 exhibition in Atlanta, GA on Tuesday, 19MAY09.
Kymanox is looking forward to re-connecting with old friends and colleagues as well as meeting new individuals and businesses.
Although Kymanox is not exhibiting this year, attending this event is a top priority. The Biopharmaceuticals industry changes quickly and BIO is a great way to keep current with everything that is happening. Kymanox is committed to retaining and developing new relationships with industry solution providers and keeping up-to-date with the latest product and service offerings.
23APR09: Kymanox announces the finalists for the 2009 James J. Davis Memorial Scholarship for Students Studying Abroad
Raleigh, NC, USA | Kymanox announced today that eight students have been named as finalists for the James J. Davis Scholarship. The winner will be announced on May 1, 2009.
Kymanox thanks all who applied and extends a sincere congratulations to the eight finalists.
04APR09: President of Kymanox, Stephen M. Perry, to speak on Technology Transfer at PEGS conference on April 9, 2009.
Raleigh, NC, USA | Stephen M. Perry, the president of Kymanox, will speak at the annual PEGS conference at the Westin Copley Place, in Boston Massachusetts on April 9.
The presentation, entitled “Technology Transfer to Manufacturing: The Key to Successful Commercialization”, will focus on the distinct differences between development and manufacturing groups, and how to manage these differences to ensure success in technology transfer. Please visit the PEGS Website for more information, and if you are attending the conference, don’t miss the presentation at 4:30 PM on Thursday, April 9.
02APR09: Kymanox announces new Process Operations service area emphasizing expertise in bioprocess technologies and strategic planning
Raleigh, NC, USA | Kymanox announced today that it has expanded its service offerings to include Process Operations. See our Process Operations section to learn more.
01APR09: Kymanox to offer 2-day seminars at NCSU’s BTEC on Technology Transfer and Project Management for Drug Development”
Raleigh, NC, USA | Kymanox announced today that leaders of the company will be providing a training seminar at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC). The course is entitled: “Universal Technology Transfer Methodologies For Biopharmaceuticals.”
The course is an extensive two-day program for professionals in biologics, vaccine and combination drug-device industries.
– Learn what technology transfer is all about
– Learn what steps to take and in what order
– Learn what tools to create and how to use them effectively
– Receive a package of procedures and templates to assist in your technology transfer projects.
Session 1 will be presented 15-16 of June, 2009. Session 2 will be presented 27-28 July, 2009 at the BTEC.
For more information, please contact Kymanox at firstname.lastname@example.org
01APR09: Kymanox expands KymaSTORE to include over 50 downloads.
Raleigh, NC, USA | Kymanox announced today that it has expanded its online store to include over 50 digital downloads for members of the Biotechnology, Pharmaceuticals and Medical Device communities.
Among the product offerings are the following:
Templates – Universal IQ / OQ Protocol Template, SOP Template, Bill of Materials Template, Audit Checklist Template, and many more.
Training Packages – Introduction to CGMP Current Good Manufacturing Practices, Introduction to CGDP Current Good Documentation Practices, Introduction to Automated In-Line Dilution, and more.
Standard Operating Procedure (SOP) Packages – Pharmaceutical Refrigerator SOP Template, Biological Safety Cabinets (BSC) SOP Template, CGMP Training System SOP, and more.
Equipment & Services – Kaye Validator 2000 Equipment, Feed Through Assembly Equipment, and more.
Visit the KymaSTORE for all of our offerings.
28FEB09: Kymanox Purchases GMPPENS™
Raleigh, NC, USA | Kymanox has purchased full ownership and all rights of GMPPENS™, CGMP Compliant Indelible Ink™, www.gmppens.com, and all associated physical assets and intellectual property from Inovadex, Inc., a diversified technology and innovation company based in the State of North Carolina. This purchase is effective today, 28FEB09.
According to Kymanox’s President, Stephen M. Perry:
“This business purchase represents a major milestone for our organization. We are committed to growing the GMPPENS™ brand and serving the needs of our clients who require products such as what GMPPENS™ offers. We also feel that GMPPENS™ will integrate well with our other existing product and service offerings.”
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06FEB09: Kymanox Announces 4th Annual James J. Davis Memorial Scholarship for Students Studying Abroad
Highland Park, IL, USA | Kymanox is pleased to announce its fourth offering of the James J. Davis Memorial Scholarship for Students Studying Abroad. Over the past three years, the scholarship has attracted applications from a large and diverse pool of highly qualified students planning to study abroad. It has continually received growing interest each year.
The 2009/2010 scholarship is open to all US undergraduate students studying abroad through accredited US colleges or universities. The selected recipient will receive $1000.00 (US) for 2009/2010 educational-related expenses.
“Kymanox is happy to invest in such promising students and proud to honor the memory of James J. Davis in this way,” says Kymanox President, Stephen M. Perry, PMP.
23SEP08: Stephen Perry of Kymanox Speaks at PDA Event
Raleigh, NC, USA | Stephen M. Perry, PMP, President of Kymanox, spoke today at the PDA Southeast Chapter’s Fall 2008 Meeting. Stephen’s talk was titled “Leveraging Statistical Methods and Analysis for Validation” and addressed the fact that “n=3=validated” is not consistent with the FDA’s 21st Century approach to quality and new global quality systems such as Q10. Adopting the principles of QbD also means adopting practices that are rooted in sound science – which includes statistics. It is imperative that validation efforts utilize statistical methods to help determine sample sizes, acceptance criteria and related data evaluations. With proper awareness and training, both technical and quality individuals should be able to use the most common statistical tools and know when situations require consultation by a trained statistician.
A 1-page memo summarizing this improved approach to determining validation sample sizes was provided to event attendees and the entire presentation is available upon request by contacting Stephen at +001 847-239-2710.
Kymanox also participated at the event as a sponsor and was appreciative of all the support given by the attendees and PDA. Justin Pawlik (Associate Director, Midwest Operations) and Timothy Miller, MS, MBA (Technical Project Manager) were present from Kymanox.
04MAR08: Kymanox launches KymaStore™
Highland Park, IL, USA | Kymanox has launched KymaStore™, an online store offering new products for a variety of needs in the pharmaceutical, biotechnology and life science industries. KymaSTORE is a brand new offering from Kymanox, and will add new products on a continuous basis.
The templates available are “project accelerators” since they can be downloaded in minutes to provide the quick start a project task may require. Training packages are designed to provide complete solutions to your training needs; the packages can be edited for further enhancement or branding. KymaSTORE is also a licensed distributor for GMPPENS.COM.
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31JAN08: Kymanox is creating a Solar Buzz
Highland Park, IL, USA | Kymanox, LLC has announced that it will be launching a solar panel installation project. The focus of the project is to make solar panels more accessible to the masses. Kymanox is demystifying a technology that is sure to be a critical player in the energy crisis debates that have already begun. The project was just launched in September 2007 and will be publicly implemented by December 2008.
In support of this technology and environmental sustainability, Kymanox has dedicated time and resources to develop the expertise related to solar energy. Kymanox will leverage its versatile technical project management capability in both Highland Park, IL and Research Triangle Park, NC. With that knowledge, Kymanox will manage and document the implementation process for solar panel distribution from conception to installation. At least one organization will be awarded a 90% funded solar panel installation (up to 3kW), courtesy of Kymanox and our partners, to propagate the understanding of solar panels and their utility in today’s energy market.
The process of installing one solar panel or even an entire system should be as easy as buying a new fence for your house. Kymanox and our partners will do just that with this project. The future is our collective responsibility.
19OCT07: Kymanox Releases Website Version 3.0
Kymanox has released Version 3 of the Kymanox website, with enhanced navigation features. Enjoy the new site and please send us any comments.
16OCT07: Encova Consulting and Kymanox Sign Strategic Agreement
Kymanox and Encova Consulting have formalized an alliance partnership to provide reciprocal professional services. Encova Consulting, managed by Richard A. Mineo, PE, brings Kymanox additional resources and expertise in engineering, commissioning, validation and quality assurance. Additionally, Encova is able to provide Professional Engineering services for work requiring registered PE credentials. The two companies have been working together since 2005. This formalized agreement will strengthen the partnership as well as extend a variety of benefits to Encova’s and Kymanox’s clientele.
15AUG07: Solar Project Launched
Kymanox launches new project – visit http://solar.kymanox.com to learn more.
13AUG07: Jeff Jones Fills Open VP Position
Kymanox is pleased to announce that Jeff Jones has taken the full-time position of Vice President of Midwest Operations. “Jeff is a high-caliber, senior executive that adds a new dimension to Kymanox; his extensive experience, knowledge base and network will prove to be an asset to our clientele,” said Stephen Perry. “Additionally, Jeff is the kind of person that is able to attract and develop talented team members in support of our growing business in the Midwest.”
06AUG07: Kymanox Supports Alzheimers Cause
Kymanox made a small donation to the Alzheimer’s Association of Greater Illinois via Bryan Tillman’s Chicago Marathon donation page. “Bryan’s approach to fund raising is ‘grass-roots’ and makes donating a more personal experience; we wish Bryan the best as he trains for the marathon and raises funds for a great cause,” said Stephen Perry.
02AUG07: Amy Finch Awarded JJD Scholarship
Kymanox has announced Amy Finch as the recipient of the 2007 James J. Davis Memorial Scholarship. The James J. Davis Memorial Scholarship is for study abroad students. Winners receive $1,000.00 (USD) for educational-related expenses. The goal of these funds is to encourage students to study abroad and experience something new to grow their knowledge of the world.
Our 2007/2008 winner is Amy Finch, a student at Tulane University in New Orleans, LA studying Public Health and Spanish. She is currently studying abroad in Salvador da Bahia, Brazil where she is doing HIV research and studying Portuguese. In the future, Amy hopes to assist AIDS patients in Africa and conduct more HIV research. Brazil has strong cultural ties to Africa and her time there will be a stepping stone to achieving her ultimate goal.
This scholarship is awarded in loving memory of James J. Davis. Mr. Davis, known to most as Jim, was a dear friend and colleague to Kymanox founder, Stephen M. Perry. Jim embraced continual learning through new experiences. He never took short cuts and didn’t feel they worked. In order to really know something, he felt you had to experience it, to live it. Jim was constantly seeking out new experiences to broaden his knowledge of the world. It is in this spirit that the scholarship was designed.
The James J. Davis Memorial Scholarship is offered by Kymanox. Founded in 2004, Kymanox is focused on facilitating effective and efficient knowledge transfer. The name Kymanox was derived from Greek and means Ideal Knowledge Transfer™. The company specializes in technical project management and engineering services within the Life Sciences industry.
01AUG07: Kymanox to Host Lecture & Learning Series at RTP’s NC Biotech Center
Kymanox is currently developing the outline and materials for this first-time event to be held in late 2007 or early 2008. Collaboration partners, guest speakers and ideas for focus group discussions are being sought.
23JUL07: New Careers Section on Kymanox Website
Kymanox unveils the “Careers” section of the company website. Continued growth and demand for technical project management and engineering services has created several new full-time positions at the company.
20JUL07: Kymanox Plans Expansion to Research Triangle Park (RTP), Raleigh, NC
Plans are underway to open a new office in Research Triangle Park, North Carolina by October 2007. Currently, Kymanox has one contract with an area firm as well as a strong network of potential clients and alliance partners. Based on all the current and planned biopharma projects in RTP and surrounding areas, the timing of the branch office opening is ideal. The new RTP office will strengthen Kymanox’s overall offerings create a synergy with the Midwest office.
JUL07: Kymanox Awarded Contract to Qualify CGMP Biotech Lab at World-Renowned University
Details of this contract are confidential.
JUL07: Kymanox Awarded Contract to Provide Engineering Services for New Automated Sterilizing Unit
Details of this government contract are confidential.
05JUN07: Kymanox Welcomes New Team Member Thomas V. Colace
Thomas Colace, a rising senior at Northwestern University, is enrolled in the Chemical Engineering program. Thomas has done work in team project-based settings through academic research and past summer work experiences. He brings to the company his creativity and interpersonal skills to support Kymanox projects in the Chicago area as a Project Specialist.
JUN07: Kymanox Awarded Engineering Contract for Peptide Synthesizer and Purification Systems
Details of this contract are confidential.
16MAY07: Kymanox Welcomes New Team Member Sarah E. Gersdorf
Sarah Emily, a rising senior at University of Illinois – Chicago, is enrolled in the Bioengineering program with a specialty in Cell and Tissue Culture. Sarah has experience as a team leader and administrator for nonprofit organizations and a strong customer service focus. She will be working as a Project Specialist supporting Kymanox projects in the Chicago area and the James J. Davis Memorial Scholarship.
07MAY07: Kymanox hosts Booth at BIO 2007
Stephen M. Perry, John E. McLaughlin, Kevin C. Brown, Bryan A. Silletti and Sarah J. Perry all pitched in to greet colleagues at the company’s first BIO event as a vendor. The 2007 BIO Convention was held in Boston, MA and attracted over 22,000 attendees from all over the United States and 64 different countries.
27MAR07: Tour and Lecture for Notre Dame Alumnae and Friends
Regis Technologies and Kymanox hosted an event for Chicago area Notre Dame alumnae and friends on-site at Regis Technologies in Morton Grove, IL. The evening started with a presentation by Kymanox President, Stephen M. Perry. Notre Dame Professor Joan F. Brennecke gave a lecture about the benefits of using greener solvents and filled attendees in on new developments at the Notre Dame Energy Center, of which she is the director. Louis Glunz, IV, President of Regis Technologies, led a tour of the manufacturing facilities there. Dinner and an opportunity to network and catch up with old friends followed. Donations were collected for Notre Dame’s General Scholarship Fund at the end of evening.
15FEB07: Kymanox President Selected to Instruct Technical Project Management Training Course
Stephen M. Perry, PMP will be instructing multiple, two-day sessions in 2007 for PTi’s course titled, “Project Management in Drug Development: Phase III and Commercialization.” For the course outline, dates, locations and other information please visit PTi International’s web site at www.pti-international.com.
15FEB07: Kymanox Announces 2007 Summer Internship Program
Continuing the program from 2006, Kymanox is searching for 1-2 candidates for a unique summer internship program. William Padula, a graduate of the program, is coordinating this year’s selection process; all finalists will interview with Stephen M. Perry, PMP, President.
Kymanox Announces the BETA Release of KymaPro™ Online Project Management Software
Kevin Brown and Stephen Perry have completed initial development of KymaPro™ – a second generation project management software that expands on Kymanox’s current expertise in integrating available information technology for managing large, technical projects. Current and future customers will benefit from access to the best web-based, collaborative software available.
13FEB07: Kymanox Reaches Milestone and Issues Payment to Its 20th Hired Resource
Since the company’s inception in late 2004, Kymanox has qualified, hired, utilized and paid 20 individual employees, contractors and interns to work on and lead various company projects.
12FEB07: Kymanox Announces the 2007/2008 James J. Davis Memorial Scholarship for Students Studying Abroad
Kymanox, LLC is pleased to announce its second offering of the James J. Davis Memorial Scholarship for Students Studying Abroad. In its inaugural year, the scholarship attracted applications from a large and diverse pool of highly qualified students planning to study abroad. From the 327 applicants, 30 finalists were chosen and interviewed. The 2006 scholarship recipient, Javid Riahi, a Biology/Environmental Studies Major at St. Louis University is currently in Madrid, Spain on a year-long study abroad program. The 2007/2008 scholarship is open to all US undergraduate students studying abroad through accredited US colleges or universities. The selected recipient will receive $1000.00 (US) for 2007/2008 educational-related expenses. “Kymanox is happy to invest in such promising students and proud to honor the memory of James J. Davis in this way,” says Kymanox President, Stephen M. Perry, PMP.
29JAN07: Regis Technologies and Kymanox to Host Tour and Lecture for Notre Dame Alumni and Friends
Regis Technologies and Kymanox announce a seminar event to be held on Tuesday, 27 March 2007 from 4:00 to 7:00 PM CT at Regis Technologies, Inc., 8210 Austin Avenue, Morton Grove, IL 60053, Phone (800) 323-8144. The event is aimed at Notre Dame Alumni who have backgrounds in chemistry and chemical engineering and are working in the Life Sciences. The event will include a tour of Regis’ manufacturing and laboratory areas, an introduction presentation, a featured lecture by distinguished Professor Joan F. Brennecke and a dinner to follow. The purpose of this event is to stimulate professional networking among Chicagoland alumni, exchange ideas and experience among academia and industry and expose individuals to new people and technology. For additional information or to RSVP, please contact Sarah at email@example.com or telephone +1-224-766-6217.
22JAN07: Kymanox Hires Vice President of Human Resources and Administrative Affairs
Sarah J. Perry, previously a senior manager at J.P. Morgan Chase, has taken a full-time position at Kymanox to lead all HR and administrative activities within the company.
Details of this contract are confidential.
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09JAN07: Kymanox Completes Commissioning and Validation Package for CGMP Equipment Valued at 1 Million USD
Details of this work are confidential.
01AUG06: Javid Riahi is Kymanox’s Scholarship Recipient
Kymanox is extremely pleased to announce the recipient of its 2006 James J. Davis Memorial Scholarship for Students Studying Abroad: Javid Riahi. Javid is a Biology/Environmental Studies major at Saint Louis University in St. Louis, MO and will be spending a year in Madrid, Spain. A heartfelt thanks goes to every one of our finalists and applicants. We are looking forward to awarding more funds to more students next year.
24JUL06: Local IT Support Now Available
Kymanox is now offering local IT services to Highland Park, IL small businesses. Visit the Kymanox web site to learn more!
15JUL06: Scholarship Finalists
30 finalists, out of 326 applicants, have been selected for the James J. Davis Memorial Scholarship. The award recipient will be announced on or before 01AUG06.
30JUN06: Deadline for JJD Scholarship
The deadline has passed for the James J. Davis Memorial Scholarship. Finalists will be announced on 15JUL06 followed by the award selection on or before 01AUG06.
20JUN06: Kymanox Welcomes New Team Member William Padula
William Padula, a chemical engineering graduate of Northwestern University, is the latest addition to the Kymanox team. Bill will be working as a versatile Project Engineer this summer until he returns to school to obtain his master’s degree in biotechnology.
14JUN06: Kymanox Welcomes New Team Member Molly Thompso
Molly Thompson, a rising junior at Northwestern University, is employed as a Project Engineer Intern. She is enrolled in the chemical engineering program at Northwestern and has previous working experience in Information Technology (IT).
17APR06: Kymanox Creates Paid Internship Opportunities in Highland Park, IL
Kymanox announces the creation of internship openings for college students who are studying at an accredited university. The positions will go to talented and ambitious students who want to learn about biopharmaceutical manufacturing and make an impact at a small but growing company.
12APR06: Kymanox Attends Record-Setting BIO 2006 In Chicago
Kymanox visited several of the 1,500 exhibitors at McCormick Place in Chicago, IL over a 3-day period. The event had nearly 20,000 participants and featured speakers such as former US President Bill Clinton and CEOs of major biopharmaceutical companies.
03APR06: Kymanox Creates the James J. Davis Memorial Scholarship for Students Studying Abroad
Kymanox announces the creation of this new $1000 (US) scholarship for US students who plan or are studying abroad under an accredited program.
23MAR06: Kymanox Attends Interphex 2006 in New York, NY
13MAR06: Kymanox Announces IBC Raffle Winner
Kymanox announces the winner of its iPod raffle for attendees of IBC’s recent Carlsbad, CA conference which covered topics like Technology Transfer and Outsourcing of biopharmaceuticals. Jim McAllister has won a new 1 GB iPod Shuffle music player which will ship DHL Express as soon as a confirmed mailing address is obtained. Thank you to all who participated!
01MAR06: Kymanox Attends IBC’s Conference on Technology Transfer and Outsourcing Manufacturing of Biopharmaceuticals
Stephen Perry, PMP was pleased to attend the first-ever IBC conference on technology transfer – a core competency at Kymanox, LLC. The conference was held in Carlsbad, CA and took place on 27-28FEB06.
01FEB06: Kymanox’s Stephen Perry Joins International Society of Pharmaceutical Engineers (ISPE)
01FEB06: Kymanox Releases Inaugural Issue of KymaNEWS | Biopharma (Vol. 1, Issue 1)
A new publication was created today and sent to a host of professionals in the biopharma/biotech industry. The focus for this first issue was to provide useful data summaries relevant to the industry in 2005 and provide an outlook on 2006. Future issues will cover specific topics like PAT, technology transfer, CMOs, etc.
If you would like to be added to the distribution list or are interested in writing an article for the publication, please send your request to firstname.lastname@example.org. Advertising space is also being offered at this time.
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19JAN06: Kymanox and KMB Innovations Announce WorkForceDB
Web hosting services were secured today for a new, on-line database that will provide networking-type services to biopharma/biotech professionals. The domain, www.workforcedb.com, will be available for initial browsing by mid-April 2006. Volunteers are being sought to provide information for the initial population of the database; if interested, contact email@example.com or use the email form located on the Kymanox contact page.
31DEC05: Kymanox Sends Happy New Year Wishes to Clients, Partners and Friends!
08DEC05: Kymanox Holiday Happy Hour
Clients and friends of Kymanox in the RTP, NC area are welcome to attend a Holiday Happy Hour from 5-7 pm near RDU airport on 14DEC05.
02NOV05: iBIO’s Midwest Meeting in Chicago
Stephen M. Perry, PMP attended this 6th annual meeting in preparation for BIO 2006, which is scheduled to take place in Chicago for the first time this coming April. Some of the topics covered at the iBIO Midwest Meeting included: research tools, patents and licenses, public policy and market trends. G. Steven Burrill, CEO of Burrill & Company, was the main speaker and sponsor for the event.
23SEP05: BioProcess International 2005 World Conference and Exhibition in Boston, MA
Kymanox President, Stephen M. Perry, PMP, attended this IBC Life Sciences conference from September 19-22, 2005. The following biopharmaceutical production topics were addressed: (1) production & economics , (2) scale-up from bench to clinic, (3) cell culture & upstream processing and (4) recovery & purification (agenda-at-a-glance / full-brochure). Several people enjoyed a clipper ship cruise hosted by Irvine Scientific, including representatives from Amgen and Diosynth Biotechnology. Mr. Perry looks forward to seeing everyone again next year!
03AUG05: Kymanox Organizes as a Limited Liability Company (LLC)
Kymanox today organized as an LLC in the State of Illinois. LLC’s are similar to corporations as they establish a separate legal identity from their owners and managers. The new legal name is “Kymanox, LLC.” However, “Kymanox” will still be used as the primary company identifier on documents, marketing materials, etc.
05MAY05: Version 2.0 Web Site Unveiled
Kymanox has reprogrammed its web site using Macromedia’s Dreamweaver MX 2004. The known incompatibility issues with Microsoft’s FrontPage server extensions were the primary driving force behind this change; Mozilla and Mac users can now access the site. Please browse for new and old content in the new layout. The old web site can be accessed at http://www.kymanox.com/v1
27APR05: Kymanox’s Stephen M. Perry completes PMI’s PMP Certification
With a passing score on PMI’s Project Management Professional (PMP) exam, Stephen M. Perry is now a certified PMP. Professional project management encompasses 9 key knowledge areas within 5 process groups, plus ethical and code-of-conduct standards. Mr. Perry took the initial 7-day certification course from the International Institute for Learning (IIL) and successfully completed the application and exam process on the first attempt.
21APR05: Kymanox is Introduced to Comprehensive Compliance Solutions, Inc. (CCS)
Kymanox was introduced to Comprehensive Compliance Solutions, Inc. (CCS), a consulting company based near the D.C. Metro area. Founders Ms. Betty Jones and Ms. Sandra Whetstone have extensive experience at the FDA and are well-suited to provide strategic regulatory guidance in the following categories: drugs, biologics, medical devices, foods and animal feed & drugs. In addition to assisting companies with FDA audits and solving compliance issues, CCS is also focused on prevention and risk assessment to help guide quality, regulatory and business decision making.
11APR05: President of ASI Meets with Kymanox
Kymanox met with long-time acquaintance and ASI (Automated Systems, Inc.) President Laszlo Kucsar. Stephen Perry worked closely with ASI while at Abbott Laboratories. ASI was the key factor in successfully meeting the requirements and deadlines of several large validation projects in the R10 Recovery Pilot Plant. ASI has a skilled and experienced workforce numbering over 50 and provides variety of compliance, systems development and consulting services.
07APR05: Kymanox Meets AsahiKASEI Representatives
Kymanox was able to meet key business, marketing and technical representatives from AsahiKASEI (Planova Division), which has headquarters in Japan. AsahiKASEI is the manufacturer of Planova® filters. These hollow-fiber filter cartridges may be used for virus removal during protein purification of cell culture products. AsahiKASEI utilizes a specialized Gold Particle Test (GPT) for post-use integrity testing. Combined with a simple leak test, GPT provides a comprehensive and validation-capable system for virus removal, which is essential for process validation and, ultimately, ensuring product safety. The company is currently developing a fully-automated integrity testing unit, called the AGTPS, to further enhance testing throughput, ease-of-use and regulatory compliance.
07APR05: TechniKrom’s Skid and Column Technologies Are Reintroduced to a Biotechnology Manufacturer
TechniKrom, Inc. utilizes key technologies, like Adaptive PAT® and Dynamic Axial Compression (DAC), that are paving the way for improved manufacturing control and efficiency. Adaptive PAT® is well-aligned with the FDA’s publicized initiative for implementing Process Analytical Technology (PAT). TechniKrom is an experienced, full-service equipment manufacture and Kymanox is pleased to recommend TechniKrom to manufacturers that can benefit from their specialized products and services.
24MAR05: Kymanox Meets President of Regis Technologies
Today Kymanox met with Louis Glunz, IV, President of Regis Technologies, Inc. A tour was provided of the CGMP facility qualified to manufacture small-molecule active pharmaceutical ingredients (APIs) and specialty intermediates. Mr. Glunz is a University of Notre Dame alum and hails from the prominent and successful Glunz family. Based on Mr. Glunz’s idea, Kymanox and Regis Technologies are interested in organizing a Fall 2005 meeting with Chicago-area Notre Dame alums that are involved in pharmaceutical-related business, science and engineering; if you are interested, please send email to firstname.lastname@example.org.
24FEB05: Kymanox Visits Startup in Bloomington, IN
Cook Pharmica is currently building a new biotech contract manufacturing organization (CMO) in the heart of the Midwest. This is a welcome sign of an expanding biotech industry that historically has been concentrated on US coasts and locations overseas. Cook Pharmica is making smart-use of a vacant television assembly plant to serve as an outer shell for its brand new facility. Kymanox was pleased to meet President Jerry C. Arthur who is parlaying his success with Cook Pharmaceutical Solutions which was sold to Baxter in 2001 for $219 million. Mr. Arthur has a related feature article in BioProcess International (Feb05 / Vol 3 / Supplement 1) titled, “A Case Study in Parenteral Filling: Modular Construction Meets the Need for Speed.”
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30JAN05: Kymanox News Update (RE: Web site)
Kymanox goes live with its first web site, Version 1.0. Frequent updates are scheduled in the next several weeks based on anticipated feedback. Visitors are encouraged to provide feedback (i.e., comments, questions or suggestions) by sending an email to email@example.com.
01AUG04: Kymanox is founded by Stephen M. Perry
Kymanox’s name, logo, business plan, marketing plan, web domain and other
systems were initially developed for business launch.