This comprehensive case study explores Kymanox’s approach to ensuring a seamless and compliant technology transfer of a biologic product to a Contract Development Manufacturing Organization (CDMO) through innovative solutions. Our team of SMEs collaborated closely with stakeholders to implement measurable improvements across process optimization, risk management, and quality assurance for Drug Substance (DS) and Drug Product (DP) manufacturing.
CHALLENGE
SOLUTION
RESULTS
- Large pharmaceutical client needed a seamless technology transfer of a biologic product to a CDMO for DS and DP manufacturing.
- Requirements included regulatory compliance, operational efficiency, and preservation of product integrity during transfer.
- Conducted comprehensive due diligence for potential CDMOs, including issuing Requests for Proposals (RFPs) and utilization scorecard evaluations to select the best partner based on capability, compliance and quality standards.
- Managed detailed scope, budget, and schedule planning to drive timely and cost-effective execution.
- Authored technology transfer plans and reports covering manufacturing processes, analytical methods, and packaging strategies.
- Developed risk assessments, Detailed Product and Process Descriptions (DPPD), and robust control strategies to support regulatory filing and ongoing oversight.
- Designed and executed a Design of Experiments (DoE) study to optimize critical process parameters and define the design space.
- Performed root cause analysis on process deviations, ensuring rapid issue resolution and process robustness.
- Implemented a Continued Process Verification (CPV) Program to maintain process control and product quality, providing ongoing technical support post-transfer.
- Successfully facilitated the technology transfer of the Client’s biologic product by leveraging detailed evaluation and project management, ensuring the CDMO maintained compliance and product quality throughout the transition.
- Enabled the client to achieve efficient technology transfer, minimize risk, and uphold high-quality standards from process development through commercial manufacturing.