Active Pharmaceutical Ingredients (APIs) are the superheroes of any commercial drug product. In essence, the drug has no strength without them and are really useless, vacant mediums just waiting for a purpose. The API is what shows a disease or condition who’s boss; it’s what produces the intended effects of a treatment or therapeutic.
Drugs are made up of two key elements: the API and the excipient. The excipient is the chemically inactive substance that delivers the medication to the human body. Excipients can come in the form of binders or coatings and delivered as tablets, capsules, oral liquids, topical creams and gels or injectables.
While there was a time when pharmaceutical firms would create the APIs, the excipients and package it all up themselves for delivery, today Contract Development & Manufacturing Organizations (CDMOs) help do the heavy lifting. They develop and produce proprietary APIs that can drastically accelerate time-to-market for generic drug projects.
Given their starring role in drug development, it’s no wonder that the global active pharmaceutical ingredients market size was valued at USD 187.76B in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.6% from 2021 to 2028, according to Grandview Research. It’s clear that given the size, it’s a competitive market with lots of commercial API manufacturers to choose from.
So what should you look for when selecting a CDMO to fulfill your API manufacturing needs?
The Five Requirements for Proprietary API Providers:
- Scalability. It’s important for a CDMO to be able to scale to meet your changing needs. You should make sure it can produce larger volumes of the API if that’s what’s needed down the road. Likewise, if smaller volumes are what will be required in the future, you need to make sure that the CDMO won’t abandon or decline your project for larger ones that will take priority.
- Quality. Inquire with the CDMO about its inspections history, how many warnings it has received and how many APIs have been approved. It’s also important to find out about its current Good Manufacturing Practices (cGMP) strategy. Does it have full GMP suites and abide by the recommended best practices of cGMP?
- Consistency. Related to quality, the CDMO should have process controls in place that help reduce the risk of out-of-spec impurities in drug products. Quality guidelines for acceptable levels of impurities are provided by the International Council for Harmonization (ICH). Ask potential CDMOs about their approach to process controls for impurities, as well as API properties, such as particle size of the drug substance, which is essential to consistent bioavailability. They should be able to share the steps they take to ensure consistency regardless of the batch size.
- Supply chain. One of the biggest challenges in API manufacturing is the availability of raw materials. Inquire about the CDMOs ability to secure timely delivery of needed materials in the quantities that are required. One of the key benefits of working with a global CDMO like Seqens is that we have multiple sources of suppliers, as well as proprietary APIs available thanks to our different operations around the world, including five cGMP plants in Europe and the U.S.
- Process improvement. Sponsors benefit when conscientious CDMOs continuously strive for improvement, monitoring and tweaking the manufacturing process to streamline production processes and improve yield. The more efficient the process, the lower the API cost and the greater the reduction in waste. Ask the CDMO how it has implemented process improvements while keeping within regulatory approvals.
Seqens and Its Proprietary APIs
A consideration when selecting an API manufacturer is the breadth and depth of its offerings. For example, Seqens currently has more than 42 proprietary APIs under development in the U.S. and Europe, including exclusive generic APIs available in all forms, including Crystalline polymorphs.
From both the IP and technical point of view, the success of a new API project depends on solid-form changes during drug development. Crystalline polymorphs have different melting points, solubility, dissolution rates and other physical properties that affect bioavailability, first pass metabolism and toxicity, as well as chemical and physical stability. We have the industrial experience to manufacture API polymorphs in a stable and reproducible manner, and we can customize particle size distribution to meet very specific requirements.
In addition, Seqens has significant expertise in developing chiral pure APIs from a catalog of racemic APIs, and we can apply our processes to racemic molecules produced by other manufacturers.
Another important consideration of a CDMO is its ability to up production, whether it’s for proprietary or custom APIs. Here are Seqens, we have 1 000/m3 of cGMP production capacity, 130 R&D chemists and seven pilot units providing first class R&D capabilities, and proprietary technology, such as biocatalysis, to develop unique processes. It’s crucial that a CDMO has the capacity and competence to scale up production as needed, and to handle regulatory filings at every stage and in all markets.
APIs are what bring life to a drug, and it’s critical that any company that produces your valuable API has the experience, insights and capacity to help you accelerate your projects with proven substances that result in successful drugs.
For more insights read What Should You Look for in a Consultant to Manage Your API Project?; Incomplete Documentation Can Make or Break Projects in API Manufacturing; or The Top 5 Reasons API Projects Fall Behind Schedule.