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:
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.