Is Your CMO Qualified to Handle Your API Project?

By the time your molecule is brought to a Contract Manufacturing Organization (CMO), much discovery, research, preparation and investment has gone into your project. So it’s no wonder you are worried. It’s like sending your child off to college – to the wide-wide world of the unknown that is out of your hands.

So how can a sponsor select a CMO that’s up to the task? This requires due diligence and homework, combined with a healthy dose of gut instinct. You need to feel that your CMO has not only the expertise and capabilities, but also that it is trustworthy, ethical and committed to the partnership. This article is designed to provide you some questions to ask to help determine whether a CMO is truly qualified.

The challenge for a CMO is that, unlike a job candidate who can point to similar projects and share glowing results, when working on API manufacturing projects, no two are alike. There are so many variables that go into final outcomes, and a project that goes well with one customer may not go as well with another.

All that aside, there is some serious legwork that a sponsor can undertake to make sure the CMO is the right fit for your organization.

Do your Homework

Search for any indication of the CMO’s past regulatory history, including how it measures up to industry standards. With this information in hand, you will be better equipped to evaluate what you see when you arrive on site.  For API’s, standards have changed dramatically over the last 5-7 years.  Many CMO’s have changed with the times but many still have not.

Tour the Facilities

You should always do an on-site inspection before choosing a CMO, checking out where raw materials are received and sampled, where testing takes place and what kind of protocols are followed in the production plant. Ask to meet with all of the staff who will be working on your project, starting with the project manager.

Then there are seven other questions to ask:

1. How long have you been in business? This may be a no-brainer, but it’s important to know how much experience the CMO has with organizations and projects similar to your own. While some things are out of your control when it comes to scaling up molecules, much of a project’s success is attributed to expertise, talent and skill.
2. How many molecules do you produce in a year and at what scale? Similar to the question above, this is a way to not only determine its level of experience; but it also indicates the industry’s confidence in the CMO.
3. How many repeat customers do you have? The biggest mark of confidence for a CMO is if a customer repeatedly comes to it with new molecules. Ask how many times that happens, and if you can speak to that customer. (Keep in mind: some biotechs have only one drug in development so there could be a good reason that some are not repeat customers – but the CMO should be able to explain that.)
4. Is your location convenient to me? An on-site visit is important when choosing a CMO, and in-person status meetings can be a good thing as well. For these reasons, it’s a plus when you can travel to your CMO’s labs and plant; it helps you form a stronger partnership and more clearly see first-hand who is working on your project. Additionally, if a CMO is located out-of-the country, different regulations and requirements are followed, which can add more complexity to the project and its successful outcome.
5. Are we compatible? Probably the single-most important factor of success is if both organizations share the same work ethic and work styles. Are you both open, collaborative and transparent? You want a CMO who will treat your molecule as though it were its own – because it is committed to excellence, because it wants your repeat business, and because its reputation depends on it.

So, while there are really important questions you should ask of a CMO, there are also two that you should not:

How can we cut costs? While of course it’s important to know costs for budgeting purposes, it should not be the first question you ask. A good CMO will give you a cost estimate with a good degree of accuracy (this is where the experience comes in), but the testing, scaling up and manufacturing phases are not the times to cut corners. After the amount of investment you have already made, the finish line is not when cutting corners should be the top priority. (We’ve seen a lot of problems occur elsewhere when sponsors try to cut corners – and then they come to us to try to fix problems caused by cutting corners. Invariably these projects encounter problems that delay the project timeline and have the opposite effect of increasing costs.)

What type of filter/solvent/vessel are you using? If you have confidence in the capabilities of your CMO, don’t try to get too far in the weeds. Once it has proven its expertise and understanding of your project, and together you have developed a scope of work, let the project team do its job – what you hired it to do.

Just as it is when sending a kid off to college, working with a CMO means giving up some control over your prized possession – your molecule.  Yet, with proper planning, collaboration and trust, it can help your project go to the head of the class, with successful commercialization.

Related posts:

About the Author

Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.