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:
- Protect your intellectual property. Sometimes, IP is the only true asset a virtual pharma has. If that’s the case, seek out CMOs with strong reputations regarding IP integrity. If you are considering CMOs outside the U.S., make sure to understand that country’s approach to protecting IP assets, because some countries offer no protection and corporate fraud is rampant. Some countries do offer civil litigation, but that can be expensive, time-consuming and trials may be biased against foreign companies.
- Prioritize the variables in an outsourcing relationship that are most important to you. Technical expertise is always critical, but other key variables are tight timelines, efficiency and related organizational expertise. The CMO must have a thorough appreciation for the entire scope of what is going on with this entire project and not just the material it is producing. For some projects, there may be only a few CMOs in the world that can offer a particular technology.
- Understand possible barriers to success. Language and time zones can make outsourcing to a CMO in another country more difficult but they can be overcome if needed. However, the most significant project delays are usually caused by errors in communication. No matter how much you may like a particular firm, be sure that they have the background and experience to do what you need.
- Ask direct questions on how the company operates. Prospective CMOs should have reliable and professional project management capabilities, with individuals who are empowered to make decisions. CMOs with an “order-taker” perspective get the job done but will not show any initiative, such as offering suggestions for improving processes. Also ask how the prospective CMO views itself within the overall supply chain. Proximity can be a huge advantage if you need to visit the site frequently or if the complexities in the technology require other members of your firm to do so.
- Engage QA functions before handing off the project. Virtual pharmas should consider retaining the services of a reliable QA consultant to plan and oversee the QA function before the project begins. The consultant can help determine how robust the prospective CMO’s quality systems really are, can find out if the site has been FDA inspected, and if the firm produces any commercial materials for any FDA-approved products. Also, find out how many audits its QA group has in an average quarter. Working with a good QA consultant can prevent significant problems down the road.
- Develop a technology transfer package. First, compile all the information you have in a clear concise manner for your potential CMOs to evaluate. Always include (if possible) any information on ideas or methods that have been tried but did not work. Giving prospective CMOs a consistent transfer package means they will each address consistent needs, allowing you to evaluate on an apples-to-apples basis. Also, it’s important to be honest with CMOs as to where the gaps are and what you think is needed to be successful. Depending on where those gaps are, this process can help you decide on which CMO to use.
- Consider the CMO’s reputation and reliability. Beyond IP protection, find out the CMO’s track record with projects similar to yours, when working with companies of your size and with similar chemistries. You can and should ask for references.
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?
At the end of the evaluation process, you want to select a CMO you feel comfortable with — not only one that can handle the work, but one that sees you as a partner.
Edward S. Price is the co-chair of MassBio’s CRO/CMO Committee and the president of PCI, a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. He can be reached at Ed.Price@pcisynthesis.com.
(Expert Opinion posts reflect the views of their authors, and not the views of Contract Pharma. If you'd like to comment on Mr. Price's piece, log in and start a discussion in our Comments section below!)