Proven Past Performance


Since 2004, Kymanox has completed over 2000 projects supporting companies of all sizes, from Fortune 500 to startups. We provide engineering, scientific, regulatory, and process operations support services to more than one hundred satisfied, repeat clients in the Biotechnology, Pharmaceutical, Medical Device, and Combination Product industries, all with a perfect safety record.

Kymanox Past Performance Infographic

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project title

Description

$60+ Million USD Manufacturing Capacity Expansion Project for High-Volume, Sterile-Filled Medical Device

Provided overall, supervising, and PMP-certified Project Manager to oversee all construction activities, budgets, and CGMP manufacturing readiness. Facilitated key project decision making requiring expert level engineering analyses. Managed facility, equipment, automation and utility commisioning, qualification and validation efforts. Moderated supplier relationships for multi-million dollar equipment and equipment system purchases.

Managed Global Supplier Qualification and Manament Program for Large Biopharma Company

In a multi-year program, managed and executed more than 50% of all required supplier qualifications and maintenance audits totalling hundreds of audits across the globe. Scope included suppliers for raw materials, device manfuacturing, sterile filling, bulk drug substance production, speciality pharmacy, warehousing, 3rd-party logistics, packaging, and labelling.

Facility Conceptual Design, Construction and Commissioning for $30 Million USD Multi-Purpose, Fill-Finish Facility

Evaluated FDA enforcement requests for engineering, quality control, and quality assurance improvements. Overhauled risk assessment techniques, sample plans, manufacturing control strategies, analytical test methods, and Quality-by-Design (QbD) approaches to meet all regulatory concerns and improve reliability assurance with additional cost savings related to sampling and sample analysis. Employed novel and advanced statistical techniques to deliver project success and help avert a national drug shortage.

Validation Master Planning, Risk Assessment, Policy and Procedure Development, and Life Cycle CQV for Novel Drug Particle Manufacturer

Developed policies and procedures for initial commissioning, qualification, and validation activiites to support Phase 1 through Phase 2b. Planned, executed, and closed initial facility qualification for CGMP manufacturing. Supported requalification and facility expansion qualifications through commercial launch.

Implemented Kymanox PMO System at $500 Million USD Global Excipient Manufacturing Company

Developed customized Kymanox policies, procedures, and templates for initial Project Management Office deployment. Trained 30 global employees on the new PMO system and provided two project management resources for initial pilot projects. Defined roles, recruited, and assisted with initial hiring of PMO staff.

Successfully Managed, with Increasing Responsibilty, PAI Readiness for Two Orphan Combination Products

Provided Project Management, managed FDA regulatory meetings, qualified entire commercial supply chain, supervised and summarized all process validation and stability programs, and authored CMC section of combination product submission (i.e., BLA). Formulated responses to FDA questions related to bulk drug substance manufacturing and the multi-use autoinjector device.

Addressed New FDA Requirements for Emergency Medical Device Requiring Advanced Reliability Performance

Evaluated FDA enforcement requests for engineering, quality control, and quality assurance improvements. Overhauled risk assessment techniques, sample plans, manufacturing control strategies, analytical test methods, and Quality-by-Design (QbD) approaches to meet all regulatory concerns and improve reliability assurance with additional cost savings related to sampling and sample analysis. Employed novel and advanced statistical techniques to deliver project success and help avert a national drug shortage.

Under Consent Decree Supervision, Validated Entire Asset Porfolio of Automated Drug Product Filling Equipment for a $3 Billion USD Organization

Working with organization's Quality Assurance Unit, supervising FDA Expert Consultancy, and responsible Consent Decree remediation law firm, analyized production equipment performance and automation controls to provide recommended remediation for full CGMP compliance. Completed engineering studies, commisioning activites, and full validation to restore equipment to CGMP production to avoid imminent drug shortages.

Refer to 503B Kymanox Expertise Summary at kymanox.com/503b-outsourcing-facilities/

 
Biotechnology | Pharmaceuticals | Medical Devices | Combination Products