APIを次のレベルに引き上げる：アウトソーシングする前に考慮すべき３つのステップ

• SDS/Safety information
  Safety is often a top priority for many CDMOs and understanding the handling requirements for your API will be critical to determining if and how the CDMO could work on your molecule. The right CDMO will be able to preliminarily determine the proper handling specific to their site through available data and/or guided, specific questions.
• Timeline delivery, deadlines/goals, and trial goals
  Timing needs are a critical factor to the success of your program and should be communicated to a potential CDMO. Everything from filing deadlines to corporate goals—this will help them determine resource availability as it relates to your needs. Your CDMO’s proposal should include a detailed timeline that can then be discussed further during conversations.
• Budget or funding situation
  It’s very helpful for both parties if you are transparent about your current funding situation and your goals for engaging with the CDMO. Regardless of your funding situation, transparency should make sure neither party’s time is wasted and will help the CDMO tailor a solution that fits your needs.
• Quantity
  The amount of API you’ll need expands beyond just what you will need for clinical trials—it is important to consider material for formulation development, stability studies, and testing contingencies. The right CDMO will be able to help you estimate additional material needs, but make sure you communicate what you intend the quantity to cover.
• Indication
  A potential future partner should be interested in better understanding what drives your company and the program. The right CDMO will ask about the product indication and care to learn more about the product—be prepared to share your passion and tell your story.
• Phase of development
  There are certain service aspects that vary based on the phase of development, such as analytical methods, which are developed to be “phase appropriate.” Be transparent if you are looking for only what is needed for your specific phase, or if you are forward-thinking and preparing your program long-term.
• Clinical approach
  Be open with the CDMO about your clinical plans. While it is up to you to tell your CDMO the services you need, a strong partner may recommend services often needed based on your regulatory approach. If nothing else, it will allow your CDMO to align on your company’s goals.
• Technical information
  The meat of the discussion will be focused on the technical aspects of your program. The more information you share, the more accurately a CDMO will be able to provide a proposal for development and manufacturing specific to your program needs. At a minimum, be prepared to provide your current API structure, synthetic scheme, and experimental procedures. If you have developed methods and specifications, it is valuable for your CDMO to reference these, as well.
• Multiple vendors/integrated offering
  An integrated offering is the combination of multiple drug development services within the same CDMO partner. These often include drug substance, formulation, drug product, packaging, and clinical trial distribution needs. Take some time to learn more about the CDMO’s ability to support additional services and begin to consider the pros/cons of working with multiple CDMOs or combining multiple services at a single vendor.

Once you’ve outlined your goals and commercial aspirations, it’s important to develop selection criteria. Rank each criterion by level of importance and “score” each vendor as you move through the selection process. Common criteria include:

• Capability, technology, and expertise—does the CDMO possess the technological capabilities and scientific expertise to develop and optimize a robust and scalable API process?
• Capacity and timing—does the CDMO have the production resources to meet your timing and delivery needs?
• Regulatory history and quality—does the CDMO have a successful track record with local and global regulatory agencies and adhere to strict quality standards?
• Partnerships and relationships—does the CDMO have a vast network of esteemed partners who can vouch for their performance?
• Location and geographical reach—does the CDMO have a large geographical network of internal labs and support locations?
• Integrated offering—does the CDMO provide an end-to-end sourcing solution and can they work on multiple aspects of your drug development needs?
• Security of supply—does the CDMO’s vast network of partners include vendors who can continually provide the raw materials necessary for production?
• Financial security and business continuity—does the CDMO have a history of strong financial performance and internal processes/procedures to ensure business continuity?