MANUFACTURING
(NDA), which protects the sponsor’s intellectual property.
• Submission of request for proposal (RFP) to CMOs. This is a particularly important document, which should describe the structure and details of the project.
• Receipt of the statement of work (SoW), which should describe all services provided by the CMO.
• Good manufacturing practice (GMP)/quality due diligence visit or audit to the CMO.
• Execution of master service agreement (MSA) defining the legal responsibilities of the CMO and sponsor.
• Execution of quality agreement (QA), which defines the quality-related responsibility of the CMO and sponsor. • Execution of proposal or SoW.
While the NDA, MSA and QA are important documents, they can be outsourced or reviewed by external consultants based on the existing templates. However, the RFP is the core document in this list. It is extremely important for the sponsor to describe the project structure and provide all details on the existing data and required services, including the optional ones. This will define the SoW structure, cost and timeline. Any missing or under-articulated part often leads to extra expenses and delays and may involve legal issues.
38 | H1 Virtual Events: Review and Summary Handbook
Q. Which parts of the screening process do drug sponsors tend to neglect or overemphasise? Which criteria should they prioritise, and why? A. Frequently, project sponsors focus primarily on the project cost and timeline. However, much more important criteria are related to the CMO’s technical capabilities and quality. The majority of CMOs will offer whatever the client wants, and in some cases, their CEOs will agree to a lower cost and a shorter timeline because their technical team doesn’t understand the project complexity. That’s why it’s vital to visit potential CMOs to evaluate their manufacturing facilities, available equipment, scope of current and past projects, skill set of their team, and quality system.
This is particularly important when you initiate
contracts with relatively new CMOs, since they are focusing on their own growth instead of serving their clients. For these reasons, due-diligence visits to the top perspective CMOs must be done prior to selecting the final candidate.
Q. Many of the factors you identified for CMO selection are important for the manufacture of all biologics. How do the selection criteria change for cell/gene therapy production? A. In general, we use the same selection criteria for gene and cell therapy CMOs. However, the
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