Do Your Due Diligence When Selecting A CMO

By Rob Wright, Chief Editor, Life Science Leader
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By Rob Wright

I was recently working on an article for how to select a CMO. During this process, I realized how daunting a task this must be for a company looking to contract out its manufacturing process. The level of detail and due diligence applied to this process has to be extremely comprehensive given the potential negative consequences that can result from poor selection. For instance, the FDA recently announced changes to the cGMPs for pharmaceutical companies. These changes indicate that companies need to know all of the members of the supply chain responsible for any portion of production. It is no longer good enough for a company to contract out to a CMO and expect them to handle everything. Pharmaceutical companies need to know who the CMO is using for raw materials, packing, shipping, labeling, or any other process involved in the production of the product.

It isn’t just manufacturing a safe and saleable product that needs to be considered. I heard one story about a company that had a great product with no quality issues. What became a problem was how the packaging was sealed. In this case, the company had a standard that the glue had to have a superior tolerance for holding up to temperature variations. As a result, the CMO selected the “Cadillac” of glues. Unfortunately, the most expensive might not always be the best for your application. In this case, when the package was opened, the odor from tearing open the packaging caused patients and staff to have adverse events, such as nausea and challenged breathing. Initially, no one thought it was the glue causing the problem. As a consequence, time and money was wasted on investigating how the medicine was being manufactured, not how the medicine was being packaged.

The glue manufacturer was well aware the glue was pungent and unpleasant, but no one asked the question or made “pleasant glue odor” a packaging specification. This is an example of the type of due diligence pharmaceutical companies need to consider in the CMO selection, qualification, and specification process. Additionally, the CMO should be sure to conduct its own research about the contracted company. Does the contract company truly understand the nature of the product it is asking the CMO to produce? Do not leave these issues to chance. Doing so could result in an unhappy business relationship and potential occupational illness or other serious incident in the work environment.