Pick the right manufacturing partner

If a company does decide to outsource its manufacturing for clinical trial supplies, the next step of the process (and maybe the hardest one) is to find the right partner. Different types of companies will have different priorities and needs--for example, small biotechnology startups are more likely to have to depend on outsourcing functions and capabilities downstream of discovery, and midsize companies will probably have a pipeline of drugs but not the resources of Big Pharma. Larger companies have more resources that can be devoted to the tactical selection of suppliers.

There are all kinds of CMOs, from small to large and from specialist to one-stop shop, and they are found worldwide. Which one to choose depends on the stage of development of the drug and the company's needs and available resources.

A good approach to decision making is to create a spreadsheet listing the requirements, and then rank the available CMOs according to their capabilities and other criteria--for example, maximum or minimum batch sizes, cost, ability to carry out formulation development or filling and packaging, and their resources for clinical distribution.

Before making a decision, it's important to know what a company has done before and how it works, to confirm its quality and reputation, to see where its expertise lies, and to make sure that its working styles are a good fit. For example, CMOs need to have experience in the same or related systems, especially where complex therapeutic modalities such as personalized cancer vaccines are concerned.

Pick the right manufacturing partner

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