By Frederic Baudry, Fareva
The global market for sterile injectable drugs is expanding at a compound annual growth rate of more than 7% from 2016 to 2024 and is expected to reach a value of $657 billion by the end of the forecast period, due to the growing popularity of injectable drugs, including both biologics and small molecule drugs.1
Sterile injectable drug products can be formulated as sterile solutions and suspensions. In the case of sterile suspensions, terminal sterilization of the drug product is usually appropriate. However, in some cases, the active pharmaceutical ingredient (API) is unstable and can degrade from heat, gamma irradiation, or other methods of sterilization. In these cases, sterile crystallization of the API is needed to produce a sterile powder before formulation.
Sterile crystallization is a niche technology, and only a limited number of contract development and manufacturing organizations (CDMOs) have this capability. Because the sterile powders are used to prepare suspensions for injection, ensuring sterility is essential to minimize risk and assure patient safety. Successful aseptic crystallization therefore requires extensive expertise in both crystallization and aseptic manufacturing.