What Can Happen on the Road to API Development: Five Lessons for a Successful Journey

Posted: December 27, 2016

API Manufacturing and Pharmaceutical Manufacturing

Let’s face it, the development of an Active Pharmaceutical Ingredient (API) can be a costly and time-consuming process. But what can be even more costly is having to change Contract Manufacturing Organization (CMO) partner’s mid-way.  Knowledge gained during API development is critical and often very difficult to transfer, and many companies who try to do so realize they are not only putting their project in jeopardy of failure, but are also significantly delaying any possibility of commercialization.

Yet successful development and commercialization is critical. There is currently enormous market demand for APIs because of an increasing need for pharmaceutical drugs 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 active pharmaceutical ingredient market was valued at US$127 billion in 2014 and is estimated to reach US$186 billion by 2020.  To address this situation, there are many CMOs working to help bring new APIs to market.

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To ensure that effective products meet market demand, sponsoring companies need to work with the CMO best equipped to address their specific challenges, and one with whom they feel most comfortable. There’s a lot riding on each project – including investors eager to turn a profit on their investments, or it can be the single project driving a company.

Yet, the biggest thing in the business is the unknown.  You may be working with a CMO you may never have worked with before, or one that you’ve never heard of.  Even when you do all your homework, you can have doubts that it was the right decision.

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

  1. 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 needs to be managed very closely, things can fall through the cracks, so getting to the core of the problem is crucial.

  2. Practice skepticism

    It’s all about trust between a sponsor and its CMO, but along with this trust should be a healthy dose of skepticismYou should always question what a CMO tells you, and also be skeptical about what you know is true — your own process and analytical information may not be as great as you think it is, so check it and double-check it again.  No project has ever failed because someone was being overly diligent.  And any good CMO will respect that questioning, and practice it themselves.

  3. Be transparent

    No CMO is perfect and no customer is perfect and everyone makes mistakes.  Because of this, the need to have transparency is critical.  And sometimes the problems are no fault of anyone.  You might not be able to get decent yield, or the right level of purity, and sometimes the problem is just too difficult to solve, and may require some outside expertise or specialized techniques.  CMO’s are paid to solve problems and propose solutions.

    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 can 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.

  4. Don’t be concerned with size

    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. At PCI Synthesis, many of our best customers are those that have transferred their projects to us because of bad situations with their large CMO.  They come to us with a new understanding and appreciation for collaboration, communication and specialized expertise.  Smaller CMOs are always more eager to please, because they never take their customers for granted.At the same time, look at capacity and how they manage it.  Sometimes CMOs have plenty of capacity but get too busy and can’t make material; worse, for sponsors, some of the large CMOs don’t care about losing money on particular projects and will want to make it up later.

  5. It’s never too soon to start looking for a CMO

    Before you even 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.The road to API Commercialization can be a long one, fraught with many bumps and challenges.  Finding the right CMO partner to help you traverse it can be critical to success.

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Our blog is designed to provide objective, actionable information. If this was helpful, consider our articles on Process Research Best Practices: 8 Ways to Lower Drug Development Costs and Keep Projects on Track or Four Ways the Kilo Lab Development Phase of Drug Manufacturing Can Save Time and Money.

About the Author

Ed Price CEO of PCI Synthesis
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.