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.
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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.
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.
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:
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.
Do you have questions? Talk to Ed.