Consideration for the Safe and Effective Manufacturing of Antibody-drug Conjugates

Antibody-drug conjugates are an emerging class of biotherapeutics that require unique supporting infrastructure to meet bio/ pharmaceutical industry standards for safe, effective, and reliable manufacturing. These highly potent biopharmaceuticals present a series of unique manufacturing challenges driven by their potency and raw material supply chain. Facility design must take into consideration these manufacturing challenges to ensure employee safety and robust process performance. The concepts addressed in this article convey the experience gained by Lonza during our years working with this class of biotherapeutics.