Drug Product Process Development: Ensuring A Consistent, High-Quality Biologic

The development process for a biologic is generally divided into two major parts: drug substance development and drug product development. Within those is cell line development, upstream and downstream development, process development, and formulation development. Each development process holds its own purpose along a biologic’s journey to commercialization. For drug product process development, it generates the required knowledge to ensure manufacturability of a consistent, high-quality drug product. When biopharma companies choose a partner to develop and manufacture their biologic, they sometimes run into challenges associated with drug product process development. It’s critical that biopharma companies work with a partner that has the proven expertise to conduct drug product process development on their innovator or biosimilar drugs.

In this Q&A, one Catalent Biologics expert shares his expertise with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development, and what to expect from the development and manufacturing partner during the drug product process development phase.