The API manufacturing business can be a risky one – especially when dealing with chemical substances that will be consumed by humans. But it’s not only potent drugs that create risk for API manufacturers. Risk also can come from project delays or problems in the lab or plant that can derail projects and their timelines and result in cost over-runs.
According to the consultant firm, Booz Allen, it often takes more than a decade and an estimated $2.6 billion to bring a new drug to market. And, all too often pharmaceutical companies fail to reach success. In fact, nearly 14% of all drugs in clinical trials eventually win approval from the FDA.
While the costs are high and the success rate low, it’s important for drug sponsors to do all they can to minimize risk to ensure a successful (and the least costly) outcome. Yet, many factors can impact risk, especially when it comes to drug substance manufacturing: the experience of the team producing your API; the quality or availability of raw materials; the method development prescribed; or the changing regulatory mandates that must be met. Any one of these issues can put your project at risk of going over-budget or failing, and resulting in the loss of millions of dollars with nothing to show for it. It’s quite the gamble, but on the other hand, for those drug candidates that succeed, most often the rewards far outweigh the challenges.
To minimize risk and set the project up for the greatest chance for success, below are six best practices to consider.
- Developing regulatory strategy. It’s important to understand the regulatory landscape before initiating API development. This includes the guidelines, key stakeholders and regulatory requirements. Developing a clear strategy in these areas creates a framework for the project and helps you determine the fastest route to successful completion. One way to accomplish this is to hire an experienced consultant. You can also request a meeting with the FDA for guidance. Once you have your regulatory strategy in place, the key is to share it with your CDMO in order to accurately execute chemical development processes.
- Pick the right CDMO for the job. Just like each chemical entity, each project is unique and will have its own challenges, so it pays to work with a CDMO with the experience and expertise to apply best practices it’s learned throughout the years to help boost your project’s chance for success. The key to reducing risk is to carefully vet CDMOs before picking one and once you’re comfortable with its ability to move your project forward, you should keep open the lines of communication between you and your CDMO and work in partnership each step of the way.
- Think carefully about cutting corners. Cutting corners almost never saves you money in the long run. In fact, it can add costs to your project when minor savings early on end up requiring more work to occur in later stages when more may be at stake. Listen to your CDMO’s guidance about where savings can and cannot be generated. For example, it’s often not a good idea to skimp in Phase 3 clinical trials, which have a more than 50% chance of success. At that point, there are clear clinical results, leading to solid funding and a good chance you are on the right path to commercialization. Yet, this stage of the process also means greater scrutiny by the FDA and better odds of losing a huge investment if any problems occur at this point.
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- Collaborate seamlessly. From optimizing synthesis routes and developing methods and testing, to determining packaging, delivery forms and dosage, there are a number of scientific experts involved in the process. To ensure smooth operations, all stages should communicate with one another seamlessly to share vital documentation, history and information that can impact next steps.
- Strategically vet raw materials suppliers. Quality raw materials can result in molecules with less impurities, which can significantly improve project timelines and avoid cost and time over-runs. It’s important to make sure your CDMO has good sourcing relationships with reputable suppliers, who not only provide materials of the highest quality, but also those that have back-up suppliers to ensure a steady supply.
- Minimize the number of partners. When firms use multiple CDMOs or contractors the more parties involved can mean greater chance of errors or confusion. Further, each time a CDMO works on a project, efforts might be duplicated since each firm has its own Standard Operating Procedures or strategy. Each time a project is handed off from one firm to another, a lot of time is required for effective project transfer.
Risk management in API manufacturing is crucial not only for the health and safety of critical drugs, but also for the cost and time-management consequences that can arise. Yet, carefully forming a sound regulatory strategy at the outset of projects, collaborating across all stages and trusting in your CDMO and its selection of suppliers, you can be on your way to minimizing risk and setting out on the best route to success.
Author Biography
Ed Price is founder of Seqens North America CDMO (formerly PCI Synthesis), an integrated global provider of pharmaceutical synthesis and specialty ingredients. From the company’s Newburyport, Mass. operations, Seqens N.A. CDMO provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules. Seqens is part of Seqens CDMO, an integrated global leader in pharmaceutical synthesis and specialty ingredients, delivering custom-made products and solutions to its customers that operates 24 industrial plants and 3 R&D centers in Europe, North America and Asia.