Setting The Foundation Of Success In Your Drug Development

Biopharmaceuticals, complex macromolecular drugs produced through biotechnology, encompass a diverse array of therapies and preventatives, including recombinant proteins, monoclonal antibodies (mAbs), viruses, and vaccines.

A core objective in biopharmaceutical development is to establish the safety and efficacy of investigational drugs for human use. This necessitates a thorough understanding of both the drug substance and drug product from physicochemical and biological perspectives. Consequently, regulatory bodies expect comprehensive characterization of any investigational biopharmaceutical using a wide battery of analytical methods. The inherent complexity of these products makes this a significant undertaking, often requiring orthogonal techniques to achieve a deep understanding.

Comprehensive characterization is crucial for demonstrating the comparability of a biopharmaceutical throughout its development lifecycle, ensuring no significant alterations occur from early clinical trials to commercialization. Even minor structural changes can substantially impact a product's safety and efficacy.

This brochure details the regulatory expectations for biopharmaceutical characterization, along with specific requirements for prevalent modalities currently under development.