Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Meeting the Requirements of Pharmaceutical Manufacturing

With an increasing focus on specialized medicines and complex drug formulations, the manufacturing of drug products has become increasingly complicated.

Processing and formulation of certain active pharmaceutical ingredients (APIs) may require special consideration during development and manufacture of the final formulation. Aspects such as bioavailability of the API in the body, API stability, and low dosage formulations are frequent hurdles to overcome when bringing a drug to the market.

Sterile liquid formulations are often injected into the body, making risk mitigation a critical parameter to ensure patient safety. For this reason, it is important to achieve a robust design and validation of the manufacturing process. Steps that are important to minimize risk include choosing the right process to purify the API, identifying suitable excipients, defining appropriate process validation, and selecting the right filters for final filtration and filling.

For solid dose manufacturers, typical challenges include API solubility and final formulation API stability, while controlling total cost of manufacturing in a competitive environment. At the same time, it is important to create a robust, homogeneous tablet with a consistent and reproducible release profile, while avoiding complications like capping or disintegration of tablets during packaging or storage.

Our experience in partnering with small molecule manufacturers coupled with our knowledge of our portfolio of pharmaceutical ingredients, equipment and consumables provides a lens into common challenges in final drug product manufacturing. We invite you to explore how we highlight challenges and recommended solutions.