Choosing A CDMO: Top 10 Intangibles Biotech Firms Should Consider

By Chathuranga De Silva, PhD.

If your start-up company has developed a biological product and is planning to file an investigational new drug (IND) application with the FDA or register the product with another federal agency, and you don’t have the physical infrastructure to perform manufacturing in-house, you are probably in the process of evaluating contract development and manufacturing organizations (CDMOs) that can conduct process development, scale-up and manufacturing of your product.

Selecting a CDMO is a very important decision, as you aren’t just entering a transactional relationship – you are forming a long-term partnership that can not only impact the success of your current product, but also benefit the manufacturing of future products in your pipeline.

Once you have established what your needs are and what type of CDMO you should work with, the harder part begins: how to choose between the organizations that fit your criteria. While some factors, like CDMO size, available equipment, or process development capabilities, may be easily assessed over the internet or in a short conversation, there are other criteria that, in my experience, can have a deeper, longer-lasting impact on the success of the project and can influence whether or not the relationship will become a strong, long-lasting partnership.

We can refer to these factors as “intangibles”, since they have more to do with the nature of the organization, the way in which communication flows, and the compatibility between your company and the CDMO. In this article, explore some of these intangibles, how they can shape your CDMO search, and what types of questions you can ask to assess them: