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Challenges of Small Molecule Production

Over the last 10 years (2008–2017), the United States FDA approved a total of 320 new drugs. Of these, 249 were new chemical entities (NCE) or small molecules, about 78% of the market share. In the same period, the average number of biologics doubled to seven biologic license applications (BLA) per year. Biologics are indeed on the rise. However, the average number of NCEs has not decreased either. The average number of NCEs approved by the FDA has increased slightly from 22 compounds a year in the late 90s to 24 in this decade. This article by Lester C. Taylor and Tilak
Chandrasekaran at Agilent Technologies evaluates the opportunities for small molecules, and how they can stay relevant in this ever-changing landscape. The challenges in production are discussed, including process scale-up, optimisation, analytical methods, supply chain, technology and knowledge transfer issues, and keeping up with regulations.

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