Successful API Development: Lessons from a CMO

API commercialization is a costly and time-consuming process and the companies you choose to partner with along this journey should be carefully considered.

Posted: February 28, 2017

API Manufacturing and cGMP Polymer Manufacturing

While manufacturing Active Pharmaceutical Ingredients (APIs) is a costly and time-consuming process, there currently is enormous market demand for APIs to address the challenges of an aging population, and an increasing amount of chronic diseases such as cancer, cardiovascular diseases, diabetes and many others. According to a new market report published by Persistence Market Research, “Active Pharmaceutical Ingredient (API) Market,” the global API market is estimated to reach $186 billion by 2020, up from $127 billion in 2014.

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And it’s not just market demand that’s driving new projects. There are also investors eager to turn a profit or merely survive – as the growth or demise of an entire company can ride on this one project that must be considered. One of the ways you can not only ensure successful outcomes, but also keep costs in check is to make sure the Contract Manufacturing Organization (CMO) you are working with is the right one for your project.

Yet, the biggest thing in the API development business is the unknown. There’s uncertainty about whether your drug will ever receive FDA approval and become commercialized – despite all of your best efforts. But before you get to clinical trials and approvals, you need to find a CMO you can trust. Finding the right CMO for the project is an important decision, and you need to reduce any uncertainty when evaluating (and then working with) a CMO you have never worked with before. Even when you do all your homework, you can have doubts that it was the right decision, yet choosing the right CMO is something within your control.

To help drug sponsors navigate this process, below are four best practices to consider when selecting a CMO to help with API development initiatives:

  • Understand that bigger isn’t always better: When looking for a CMO partner, it’s not always the largest one that is the best fit. Sometimes sponsors think their safest bet is to go with a large CMO, which may have more resources and staff. But it’s also possible to get lost, particularly if your project has a small budget compared to their other clients. Instead, ask the prospective CMO about how it ensures that smaller projects don’t get orphaned as resources are allocated to bigger-budgeted projects. Make sure to get commitments regarding resources, specialized expertise and timelines, as well as proof that the team will be collaborative, and transparent. Smaller CMOs are always more eager to please because they never take their customers for granted.
  • Ensure good communication: Nothing can substitute for good communication each step of the way. To ensure good communication, both the sponsor and the CMO should have good systems in place to make sure everyone is well aware of project timelines, budget and goals. They also need to immediately communicate problems that arise to ensure a collaborative discussion takes place that gets to the root cause of the problem and works to remedy it. Because so many details and aspects of API development need to be managed very closely, things can fall through the cracks, so getting to the core of the problem is crucial.
  • Insist on transparency: When problems arise, the need to have transparency is critical. Sometimes the problems are no fault of anyone, for example, you might not be able to get decent yield, or the right level of purity. Yet the sooner problems are raised, the faster everyone can work on a resolution. And the level of transparency can vary from region to region. Many countries think it’s a sign of weakness to disclose any problems in API development and manufacture, and they don’t want to burden the sponsor with the problems that are occurring, hoping they can resolve them on their own. But what is often the case, is that the problems become insurmountable and costlier, and without time to plan ahead and perhaps notify investors, things can spiral out of control. Because of this, ensure nothing less than complete transparency from your CMO.
  • It’s never too soon to start looking for a CMO: Before you think you need a partner to help develop your API, start doing your homework and leave enough time to explore your options. Additionally, lots of upfront documentation and relationship building has to take place before the project can commence, so don’t let the CMO selection delay what is usually a very long process anyway.

API commercialization is a costly and time-consuming process and the companies you choose to partner with along this journey should be carefully considered. Regardless of your choice, it all should come down to openness, honesty and trust.

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2015 Trends and Predictions for API Drug Manufacturing
How VCs are Impacting the Pharma Sector
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The key to global outsourcing – understanding US regulations
Time to address price hikes in US generic drugs
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).