CMO Selection Criteria
By Diane McGuire
When it comes to selecting the right CMO, it is important to find one with: 1) an excellent technical staff that derives great pleasure from solving my manufacturing problems; 2) a compliant, knowledgeable, and reasonable quality group; 3) well-trained, compliant personnel with a sense of urgency; 4) the lowest cost available; 5) a manufacturing site that is conveniently located next door to my office; and 6) an open-door policy through which I am welcome to drop by any time I wish. Alas, I am still in search of this CMO. In reality, the criteria one uses to select a CMO are a composite of many compromises, and there are no standard criteria that hold true for all companies or products. Technology, clinical/commercial phase, staffing, funding, criticality of manufacturing step (custom excipient vs. API), repetitive nature of task (one time only or lots every week), and complexity of program will all help shape the criteria.
Quality: As far as named characteristics, quality is assumed to be a “given” or generally stated as the number one CMO criteria for selection. Given its supposed significance, it amazes me that so many CMOs have received serious warning letters. Obviously, then, there are different degrees of quality and compliance, and the assessment of this criteria needs to be completed by competent, experienced personnel. In addition, prior experience or references are also key.
Cost: Cost can be tricky to analyze. Each vendor has its own way of quoting (some quote everything you could possibly want and others forget items), and it can be difficult to have an apples-to-apples comparison. I always have a technical person analyze costs, considering a finance/purchasing person may not catch the nuances and recognize what is missing. For highly custom type of manufacturing, cost is generally a tie-breaker-type criteria. In pharma, commodity-type manufacturing costs take a bigger role as there are more providers.
Capacity: Capacity is directly linked to timelines. A key criteria to consider prior to moving to a contract site is if the CMO, in the short run, has the capacity to manufacture your product (this also needs to be monitored in the long run). In addition, how the CMO plans capacity should also be considered. One CMO I worked with continued to not meet technical transfer timelines since it did not have the technical staff capacity to support my project. When I brought this up, I was told that it was their job to manage capacity and that they would deal with it even though they had no process to analyze it. I decided to let them have more capacity to manage — I removed my product.
Timeliness: You can ask a vendor for on-time delivery performance, but as with anything else, it all depends on how it is measured. I worked with one packager that stated it had a 99.7% on-time delivery. What they didn’t say is that if their schedulers changed their promise date, the delivery performance was against that new date. As stated previously, capacity review, number of projects, on-staff personnel, and project team structure can help ensure the key ingredients are there to meet a timeline.
Location: All things being equal, it is difficult to understand why people would choose to outsource programs in distant locations. It is always easier to pick up the phone or take a quick day trip and discuss issues than it is to get a visa and travel 14 hours to have a jetlagged conversation. However, all things are not equal, and distant locations have very low costs and an educated workforce. Additional management time, travel, and language barrier costs should be considered when choosing sites. A development-stage manufacturer will generally need much more contact than a commercial-stage company, as there are more changes in the development process.
Technology: Sometimes there aren’t many CMOs with a specific technology or approved products utilizing a specific technology. In these cases, technology is the prime consideration, and all else must be made to work in this context.
Technical Personnel: Many CMOs disclose how many Ph.D.s/Masters they have on staff. This is all well and good, but can they deliver? A better criteria would be how many commercial products have they developed and launched?
As can be seen, the key variables will change based on the outsourced projects.
McGuire is managing principal of PharmAcumen Consulting, which is a technical operations and quality consulting firm specializing in outsourcing and virtual biotech and pharma.