It’s All About the Small Things
Posted: 5 September 2024The quality of final drug products correlates directly with the quality of the raw materials, APIs, excipients, and manufacturing processes used to produce them. Contract manufacturers can ensure high quality with appropriate oversight of the supply chain, internal management and quality systems, appropriate operator and analyst training, and effectively designed facilities and equipment.
In addition to understanding regulatory expectations for gene therapies at different stages and for different end uses, service providers must work closely with their customers to understand the critical quality attributes of each product and any other product-specific requirements that can impact process design and material requirements.
With this knowledge, they can help clients evaluate, select, audit, and qualify suppliers, ideally using a phase-based approach, to ensure access to fit-for-purpose materials as projects progress through the clinic and to commercialization. Service providers with strong, existing supplier relationships/networks, strong onboarding processes for thoroughly vetting new suppliers including effective quality risk management plans offer real advantages. Along with comprehensive documentation of evaluations, audits, and quality assessments to ensure traceability, supplier monitoring programs are essential to identify trends and changes, such as shifting timelines, restructuring, mergers, etc., that may impact supplier performance.