Selecting a CMO: Criteria to Consider

Imagine this scenario: You have just joined a relatively new emerging pharmaceutical company which licensed a first in class technology from a top research university several years earlier. To date some limited process development has been done both internally and at several contract labs. A fair amount of money and time has already been expended but it's clear that the synthesis route is still far from “prime time”. It's your job to select a CMO and get kilograms made for tox studies and maybe even some early trials that are to take place in less than a year. By the way, investors are holding back funding for the company until certain successful milestones are achieved. The clinical supplies needed to achieve these milestones are your responsibility.

Although the task you're facing may seem daunting the fact is that with a little research and hard work you can be a “hero” within your organization by following some straightforward guidelines. Some important criteria that you will have to balance and consider:

1. Intellectual Property: Your IP may be the only true asset your company has. If what you have is truly novel and unique you need to select carefully. Only work with firms with strong reputations in this area. There are a number of very reliable and trustworthy firms throughout the world and even in emerging market countries as well. The problem is deciding what is the risk and possible recourse. If something were to happen overseas what could you do? In an Asian country there is almost nothing you could do. In Europe you could pursue litigation but in a foreign country it is expensive, time consuming and often difficult to prevail. Working in North America may seem to be the only choice but it may not be the right choice depending on the nature of the project.
2. Timing: Under tight time lines efficiency and organization are critical. The CMO must have a thorough appreciation for the entire scope of what's going on with this entire project and not just the material they are producing. Ask direct questions on how they operate and how they view themselves within the overall supply chain. Often time's proximity can be a huge advantage if you need to visit the site often or if the complexities in the technology require other members of your organization to visit the site frequently. The organization should have reliable and professional project management capabilities (see accompanying article in this newsletter) with individuals who are empowered to make decisions. Obviously, barriers with language and time zones can make this more difficult but can be overcome if needed. The most significant project delays are usually caused by errors in communication.
3. Technology: The fact is that for some projects there may be only a few companies in the world that can do a particular chemistry that you need. No matter how much you may like a particular firm be sure they have the background and experience to do what you need. If more general chemistry is required then you can caste a much wider net and consider more firms.
4. Quality: Has the site been FDA inspected? Do they produce any commercial materials for any FDA approved products? On average how many audits do their QA group have in an average quarter? All important information to ask for which will give you an idea how robust their quality systems really are. If your company is more virtual and you don't have a QA group then retain the services of a reliable consultant. Your QA function should be engaged from the very beginning of the process. This is money well spent and can prevent significant problems down the road.
5. Technology Transfer Package: Here is where a little hard work can pay huge dividends. First, compile all the information you have in a clear concise manner for your potential CMO's to evaluate (see accompanying article in this newsletter). Always include if possible any information on ideas or methods that have been tried but didn't work. Don't have your CMO try to re-invent the wheel. Be honest with yourself and the CMO's as to where the gaps are and what you think is needed to be successful. Depending on where those gaps are can help you decide on which CMO to use. No two CMO's are the same. They all have their strengths and weaknesses. Usually strong manufacturing companies are weaker in development and vice versa. If the gap is in the analytical area consider utilizing a contract research organization to do all the analytical development to transfer to a CMO that fits your other criteria.
6. Reputation nd Reliability: What is their track record with projects similar to yours? With working with company's of your size? With similar chemistry's? You can and should ask for references. The fact is that every CMO has had projects that were not successful for one reason or another. The question you need to ask is this an organization that I can trust to be open, honest, and upfront when things go wrong? Do they have a system in place to solve and address issues they encountered when a project is over? Do they implement changes as needed to avoid from repeating the same problems over and over?

Of course nothing can substitute for visiting and touring the facility your 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 not a good sign. Everyone should have a high level of comfort with working together. As difficult as the selection process may  be there are a number of very reliable high quality manufacturers throughout the world. PCI is continuously striving to be a world class contract manufacturing organization and we welcome the opportunity to have you consider us as your partner in developing your new molecule.