Chamow & Associates is pleased to present a blog series detailing best practices for working with a contract development and manufacturing organization (CDMO). This series is intended to provide a potential sponsor company with sound advice in finding and choosing the right CDMO for its product development and managing that CDMO to perform to the company’s expectations. We continue our series with – “What to Look for in a CDMO”.
While keeping in mind your company’s priorities as discussed in our previous article, “Determining Priorities When Looking for a CDMO”, there are a number of factors to take into consideration when looking for a CDMO. These attributes are measurable, though some may be more subjective depending on the needs and culture of your organization, and should be quantified as much as possible in the comparison spreadsheet mentioned in our prior article.
The most important question is whether a CDMO has the right technology for your product needs. Without the capability to produce your product, a CDMO cannot be a fit. The following questions can be used to assess whether the CDMO has the competency needed:
- Does the CDMO support the expression technology, microbial and/or mammalian, needed?
- Does the CDMO have expertise and resources to perform development that is needed to support production? This may include cell line, process, formulation, and/or analytical methods development, which are separate from the GMP tasks of master cell banking, drug substance, drug product, clinical labeling and clinical packaging.
- If your needs include drug substance, are stainless steel and/or single use production systems available? Are you transferring an existing process from another facility? If so, it may be necessary to match production equipment.
- Do the production scale capabilities match your product needs?
Project Management is a crucial service to look for in a CDMO. Take note of how realistic the delivery dates are and if the timeline fits your schedule. Also, during your CDMO visit, get an impression of their communication style and what the staff culture is like. Make sure this fits with your own company culture and style.
Depending on your needs and communication style, another important factor to consider can be location. Our take on this is that for preclinical and early stage clinical programs, where the CDMO has no experience with the product molecule, close communication between sponsor and CDMO is very important. The CDMO will encounter fewer issues with the program if the Sponsor keeps close tabs and is more engaged. Eventually, every project will require technical transfer. If a CDMO is technically competent and has systems tested by a strong track record, fewer issues are likely to be encountered, and those that are may be often solved by the CDMO on its own. This can make location less of an issue. However, you must assess your need for communication and desire for collaboration and how distance will affect this.
Overall, these attributes should contribute to the probability that the CDMO can deliver the quality and amount of product at a cost your company is looking for. A good CDMO will know its own strengths and be willing to seek outside assistance for areas that are gaps. Ultimately, it is all about managing risk. Keep in mind the level of risk when evaluating all of these factors.
Chamow & Associates assists companies to develop biologics for clinical testing and welcomes your inquiry. Subscribe to the Chamow & Associates blog to receive notification for new posts, including future topics for this CDMO Series.