Outsourcing production of APIs provides pharmaceutical and biotech companies the benefit of API scale-up and production expertise while allowing them to focus on their core business – the research and development of drugs.
With any successful business relationship, a great deal rests on the proper upfront due diligence. It is critical to choose an API supplier that can meet a whole host of important qualifications, from experience at various scales of production and available capacity to worldwide regulatory approvals and support as well as quality systems that mirror (or best) your own.
There are a number of criteria drug manufacturers evaluate when choosing an API supplier. Here are just a few of the key issues your company should be considering when making a decision to outsource API manufacturing.
1. Technical Capabilities
Your API supplier should be comfortable with the underlying science, and have appropriate development and analytical chemists and labs in-house to support the API in question.
2. Regulatory Capabilities
Less than 5% of U.S. FDA Abbreviated New Drug Application (ANDA) applications for generic drugs receive approval. One leading reason why such applications fail is lack of appropriate documentation for an API’s chemistry. These “chemistry deficiencies,” as they are known, can be attributed to a number of factors including: failure to disclose the use of solvents, changes in the manufacturing process, and failure to identify potentially toxic impurities.
Avoiding chemistry deficiencies comes with familiarity of regulatory matters. Make sure your partner routinely undergoes inspections from the various regulatory bodies (e.g., FDA or EU GMP) that are critical to your drug’s success. In some cases, ANDAs can be denied because your supplier was unsure exactly how to communicate with a regulatory agency. Remember, an API supplier is only valuable to your firm’s drug candidate if they can execute your project according to the various stringent regulatory criteria you must meet.
3. Scalability
Many contract manufacturers claim capacities from lab to kilo scale. Make sure your manufacturer can actually translate production across multiple scales, and has done it before. Check their track record on DMFs they’ve filed, and similar products they’ve produced. Even if you don’t plan to outsource production long term, your contract manufacturer’s skills and expertise at various scales can prove invaluable during process transfer.
Your plan for scaling and manufacturing your drug candidate is only as realistic as the capabilities of your respective partner. Many contract manufacturers have specialties – Neuland, for example, has focused on APIs for nearly 30 years. We are experienced in translating the manufacturing process across a broad range of scales and possess the knowledge of niche chemistry customers expect.
4. Capacity
Ask if your potential partner has the available capacity for your project – on your timeline.
5. Customer Relations
Can the API manufacturer provide you with the level of support and involvement your company needs or expects? You want to select an API supplier who believes customers can contribute meaningfully to solutions based on their experience and priorities, and encourages them to participate.
Technology has reached the point where clients can track – in real-time – the progress of their project, and online project management systems are a tool that can help increase the integration of international teams based around the globe. (Learn about Neuland’s GuarD system, which we use to make the manufacturing process completely transparent. It gives our customers real-time data, and allows them to participate fully in project planning.)
Selecting an API supplier for your drug candidate is about building a partnership. You need to be comfortable with your API manufacturer’s capabilities, capacities, approaches to regulatory matters, and how they will interact with you.
What do you consider the most important aspect of API manufacturing? Let us know what you think.
