April 06, 2022 by Laura Chamberlain (10 分で読めます)

カテゴリー | 低分子




  • できる限り速やかな原薬の臨床入りを実現できるか?
  • 化学と規制の両面のリスクを低減できる専門知識を備えているか?
  • 頑健かつ効率性の高い合成ルートを構築できるか?
  • 複雑な化学/力価の課題を効率的に解決できるか?
  • 開発の進捗に応じたスケールアップを実現できる生産能力、専門知識、経験を備えているか? 



Determining the right time to engage a potential CDMO is the first step and is often a challenging decision. Many new and emerging biotech/pharma companies get stuck on timing and funding, which can make them hesitate in engaging with a potential CDMO.

Engage Earlier Than You Think

The time it takes to evaluate, select, and initiate activity with a CDMO can be a lot longer than you may think. It’s important to engage a potential CDMO earlier rather than later to discuss the development and/or manufacturing of your molecule. The average time to a select a CDMO—from first conversation to initiation—takes approximately three months. By engaging earlier, you give yourself ample time to get a better understanding of your own needs and what the right CDMO looks like for you and your molecule.

There Will Never Be a “Perfect Time” to Engage

For new and emerging biotech/pharma companies, funding is a typical roadblock and compiling a full RFP is time consuming. If you find yourself facing either of these challenges, it’s important to remember that early engagement is a balancing act, and you may never find yourself in the “sweet spot” with the required funding and a complete RFP for use in CDMO discussions. This makes having transparent conversations sooner rather than later even more critical, as you can use them to refine and make decisions faster in the future. When engaging with a CDMO in the early days, be sure to ask them:

  • What amount of process development work will be required?
  • What are the lead times for raw materials?
  • How do you—the CDMO—plan to approach scale-up manufacturing?

The best information often comes through discussion and cannot be put into a technical package. Asking these questions up front can be used to craft a more thorough RFP.

Ask the Potential CDMO to Show and Tell

While many companies don’t require the assistance of a CDMO until they need GMP material, that does not necessarily mean they need to wait to engage a potential CDMO. As early as lead candidate selection, engage the potential CDMO for non-GMP material for late-stage toxicology studies. Utilizing a CDMO for late-stage tox material may cost you slightly more upfront than a CRO or non-GMP shop, but it’s worth it, because:

  • It develops rapport between you and the potential CDMO.
  • It encourages adherence to communication, timelines, quality, and delivery.
  • It weeds out CMDOs who aren’t as hands-on and willing to get their hands “dirty” with the chemistry.
  • It helps you start evaluating for potential future developments.
  • It can be done separately and won’t bind you to a CDMO—if the studies are poor, you can find a different CDMO with more experience.
  • 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?



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