Be More Innovative.
Get More Done.

TECHNICAL OPERATIONS


PROCESS ENGINEERING | ANALYTICAL SCIENCES |
PRODUCT DEVELOPMENT | MANUFACTURING SCIENCES


Product knowledge, process understanding, and patient-centricity are central to Kymanox Technical Operations. Our principles are aligned with Quality by Design (QbD), and we utilize professional project management for Right First Time success. With expertise in upstream, downstream, and fill/finish bioprocessing, as well as small molecules, medical devices, In Vitro Diagnostics (IVDs), and combination products, we help bring modern medicines to market and support ongoing lifecycle management.


Image
Image

Contact Us


Linking Development and Manufacturing


Planning and risk management are employed early in our programs to avoid costly troubleshooting down the road. Our team has proven, successful experience in the following:

    • Facility Process Designs and Product Launch for Multi-Product Facilities

    • Technology Transfer and Scale-Up for Phase I-III and Commercial Processes

    • Process Validation (e.g., PPQ), Troubleshooting, and Optimization

    • Process Design from Bench to Commercial Scale

    • Creation of Upstream and Downstream Development Strategies

    • Feasibility and Business Assessments including Cost Modeling

    • Third-Party Person-in-the-Plant Representation

    • Resource, Budget, and Capacity Planning for Development and Manufacturing

    • Fast-Track Preparation and Execution of CGMP Campaigns including Hands-On Execution and Supervision

    • Planning and Managing of Clinical and Commercial Drug Product Supply Chains

    • Process Mapping and Process Modeling

    • Advanced CGxP Statistics, Continued Process Verification, and Process Surveillance

    • Equipment, Utility, and Facility Specifications and Procurement Support

    • Turnkey Analytical Development and Qualification

    • Product Design and Enhancement

      Synergy with other Kymanox Services


      Kymanox holds a 360° view of technical operations; we augment our activities with the following capabilities:

        • Project Management Office

        • Quality + Compliance

        • Commissioning, Qualification, and Validation

        • Training via the Kymanox Knowledge Bar

        Integrating science and engineering with business and compliance, and with a focus on CGMP-compliant and technically feasible processes, Kymanox helps avoid costly and often irreversible missteps. Together with our clients, we help select and design optimal solutions which can be utilized from early development through commercialization.


          Biotechnology | Pharmaceuticals | Medical Devices | Combination Products