What to Look for in a CDMO
This article is the third part of our “Best Practices in the CDMO Selection Process” series and explores criteria for CDMO evaluation and comparison.
In this article we will focus on the evaluation of a few identified CDMOs. There are several factors to consider and while some may be subjective to your company’s needs and culture, most should be quantifiable and tracked in a spreadsheet that lets you compare potential CDMOs in a like-for-like way. Let’s review the most important factors in creating a successful sponsor-CDMO relationship.
The most important question to ask is whether a CDMO has the right technology for your product needs. The CDMO must be able to produce your product. If not, nothing else matters.
To assess the CDMO’s technology capability, ask if they have:
- Required microbial and/or mammalian expression technology
- Development expertise and resources to support production. This includes cell line, process, formulation, and/or analytical method development—tasks that are separate to the GMP tasks of master cell banking, drug substance, drug product, clinical labeling, and clinical packaging.
- Available stainless steel and/or single use production systems required for products that include drug substance (DS). Other related questions to ask here are: Are you transferring an existing process from another facility? If so, does the production equipment match?
- Production scale capabilities to match your product needs.
Project management is a crucial service provided by a CDMO. Note whether their delivery dates are realistic and if the timeline fits your schedule. Also, during your CDMO visit, observe their communication style and staff culture. Make sure this complements your own company culture and style.
Location is another important consideration. For non-clinical and early-stage clinical programs—where the CDMO has no experience with the product molecule—close communication between sponsor and CDMO is essential. Generally, a CDMO encounters fewer program issues when the sponsor is and remains engaged. Eventually, every project will require technical transfer. If a CDMO is technically competent with a strong track record of tested systems, they encounter fewer issues and often solve issues they do encounter on their own. This can make location less of a factor; however, you must assess your communication and collaboration needs as well as the impact distance may have.
Overall, these attributes should illustrate whether a CDMO can deliver the quality and amount of product at the right cost. A good CDMO will know its strengths and be willing to seek outside assistance for any present gaps. Ultimately, it is about managing risk, so weigh that against all other factors.
Check out more “Best Practices in the CDMO Selection Process.”