Working with Contract Development & Manufacturing Organizations (CDMOs) is clearly on the rise. According to an article in Contract Pharma, the outsourced manufacturing market is estimated to be valued at more than $100 billion by 2022. What’s driving this trend is the growing complexity of FDA requirements, the competitive race to bring new generics to market faster than the competition, and the explosion of innovative and targeted therapies, to name a few.
CDMOs develop and manufacture the Active Pharmaceutical Ingredient
(API) that will put your company on the road to pharma success, but it’s no
easy task. It requires a huge leap of faith and trust that your CDMO will treat
your project as if it were its own. And in many ways, it is – your commercial
success means their success and another feather in its cap.
Yet, as with many service providers that work behind the scenes,
what goes on in the CDMO’s lab, suite or plant can seem far removed from the
company hiring it, and in many cases, the sponsor wants to keep it that way. It
doesn’t care how the CDMO reaches the end-goal – the manufacture of a specific
API that meets FDA approval – they just want to see it happen. Yet, it’s wise for
sponsors to get close to their CDMO, becoming true partners and understanding
how the CDMO operates.
to know your CDMO can not only help to move projects along as quickly and cost
effectively as possible, but it also can help to take away some of the false
assumptions about how they operate.
are five of the myths about CDMOs that your CDMO probably wishes you knew:
- Time for us is always about money. Budgets for API manufacturing projects are clearly mapped out according to the project steps, deadlines, materials required and a number of other factors. But, they are only estimates, since many things can go wrong when dealing with natural science. It’s understood that when projects go beyond scope or deadlines, or amendments are required, budgets increase as well, to accommodate the need for GMP suite time, new raw materials and chemist time. Yet CDMOs never see this as a good thing. Projects with extended deadlines mean a major backlog to other projects and unhappy customers who will have their projects delayed. For a CDMO to grow, they need lots of customers – not just a few happy ones. Further, when projects stay on budget, and on schedule, we have satisfied customers who refer us to others – and that’s the best form of business growth.
- We’re antisocial. When a new drug hits the market, it’s not the name of the CDMO on the label, but that of the sponsor. CDMOs are rarely in the limelight, but that doesn’t mean we don’t know how to communicate. In fact, communication with the CDMO is critical to the success of a project. Good CDMOs should hold organized and productive meetings with their sponsors on a regular basis, including relevant team members, such as the project manager. Contrary to what may be believed, we’re not interested in keeping meetings/communication to a minimum, since valuable information can be shared in the meeting, such as past history with the API or challenges occurring that can be more successfully addressed as a team.
- A Good CDMO knows how to make raw materials behave. Regardless of how many PH.D-level chemists are working on the project, raw materials will behave as nature intended. In many instances, QA teams can solve problems and overcome issues in earlier stages as we have more leeway for impurities than later or commercial stages. Yet, there comes a point, however, when GMP requirements mean we have to scrap the batch. Expertise and experience can only bring us so far, and then nature takes its course.
- We don’t care what came before us. This myth could not be further from the truth. It’s critical that CDMOs are told about every excruciating detail about prior activities by CDMOs that could bear on the current project. Sponsors should be as open and up front as possible and share the challenges and defeats of previous efforts. Perhaps there were multiple steps of the chemistry in the plant for a long time, this history can help clarify some of the challenges we are seeing. Batch records are crucial to our understanding and we need to see cliffs of the chemistry. Not only can it help us solve the problem, but it can also save you thousands of dollars in the lab.
- We can ship under quarantine while awaiting QA approval. It is not possible to shorten timelines before testing and QA approvals are completed. This practice is no longer allowed, and in fact, can lead to a Series 483 violation. So we have to wait until approvals before shipping product.
After two decades in business, we’ve learned that good working
relationships are the key to a successful sponsor/CDMO partnerships, helping to
ensure successful commercialization and business growth. It’s important to
understand, however, the motivators, challenges and goals of each organization.
It all begins on a rock- solid foundation of mutual respect and trust.
For related articles please read: Who is Manufacturing Your Prized API; When Does it Make Sense to Use a CDMO for API Development; or Want a Strong API Launch?
About the Author
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). 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.