- How do you assess reliability of CMOs?
Troiano: Ultimately, reliability is a matter of producing the required quantity of drug product meeting all quality attributes and releasing it within the timeline established. Doing that within the proposed budget, without a lot of change orders or price increases is also important. So it’s easy to assess retrospectively. But during the selection process you need to predict how reliable they will be for you. I do this by paying attention to how competent their staff is and how efficiently they run their business through applying Quality by Design principles.
- How would you define CMO accessibility and how can CMOs demonstrate they possess this characteristic?
Troiano: Making their facilities and key technical personnel available for site visits is very important in the selection process. For me, the impression I get during a technical visit is probably the single most important factor for determining if we want to bring our business there. Once we have chosen a CMO and begin working there, allowing our technical people to be on site as often as needed during technology transfer and manufacturing is critical.
- Based on your experience, what advice would you give to those involved in the CMO selection process?
Troiano: The first thing you need to do is get internal alignment on what your outsourcing needs are. Rigorously define the scope and scale of what you want to outsource and why. Then generate a detailed request for proposal (RFP) with all of your requirements and the services you are looking for from a CMO. This includes development, manufacturing, quality control, product storage/distribution, and any regulatory support. Prior to sending the RFP, gather as much information from prospective CMOs via their website, phone calls, and references. Try to narrow the list of potential CMOs to five or less before sending out the RFP. Also, in addition to your quality audit, you should do a separate technical visit to focus on your process and any unique needs your product may have.
- What resources have you found to be highly useful in the CMO selection process?
Troiano: We have both quality and technical questionnaires that we ask prospective CMOs to complete prior to sending them a RFP. This helps us weed out companies who may not meet our needs due to an analytical requirement, capacity, or some other special need we may have for our drug product. Focus on the specifics of your product that are not routine in the questionnaires.
- What are some of the frustrations you’ve experienced in going through the CMO selection process?
Troiano: We have had some instances of CMOs who do not want to provide much information up front and insist on us sending the RFP or visiting. For example, they will not complete or only partially complete our technical questionnaire. I try to explain to them that I don’t want to waste our time or theirs if it is not a good fit. On the other extreme there have been CMOs that we think might be a good fit, but the business rep won’t reply to our messages. They either think we are too small of an opportunity or they are running at 100% capacity and not looking for more business.