According to the recent Contract Pharma Outsourcing Survey, 37% of respondents at virtual pharma companies expect to increase their outsourcing spending over the next year. Not surprisingly, but significantly, 75% of virtual pharma companies report that they outsource clinical manufacturing to CMOs while 88% reported outsourcing their API manufacturing to CMOs.
With virtual pharma companies relying on CMOs with mission critical work, the job of selecting a CMO is vital. Yet one of the challenges virtual pharmas face is that they need kilogram quantities made for toxicological studies — while their investors may be holding back funding until certain successful milestones are achieved.
Here are seven important criteria to help virtual pharmas as they select the best possible CMO partner:
Of course, nothing can substitute for visiting and touring the facility you are considering for selection. You should meet the heads of any technical or functional group you may interact with during the course of your project. If suddenly people are not available or seem to be “hidden’” by the business development mangers, take this as a bad sign.
No two CMOs are the same — they all have different strengths and weaknesses. Typically, strong manufacturing companies are weaker in development and vice-versa. If the gap is in the analytical area, consider using a CRO to do all the analytical development to transfer to a CMO that fits your other criteria.
Keep in mind: every CMO has had projects that were not successful for one reason or another. Ultimately, the most important question is: Is this an organization that I can trust to be open, honest and up-front when things go wrong? Does it have a system in place to solve and address issues encountered when a project is over? Does it implement changes as needed to avoid repeating the same problems over and over?