Protein Characterization Through the Stages

Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.
Aug 01, 2010

ABSTRACT


Photo courtesy of: DASGIP
Protein characterization plays a critical role in determining the safety and efficacy of biological products. Advances in analytical techniques have given biopharmaceutical companies new methods for characterizing their products; the challenge has become choosing the right combination of methods. Biomanufacturers must leverage their experience to determine which methods to apply at each stage of the drug development process, and use a risk-based approach to guide their selection.

Protein characterization plays a critical role in the discovery, development, and manufacture of biopharmaceutical products. Unlike traditional pharmaceutical companies, biopharmaceutical manufacturers must rely on complex biological systems to produce their therapeutic products. The inherent variability associated with biological expression systems necessitates comprehensive characterization of the final product to ensure comparability throughout the development process and from batch to batch post-approval.1 The advent of biosimilars has given protein characterization further relevance as it forms the foundation for assessing relative similarity. Advances in analytical techniques have given biopharmaceutical companies new and increasingly sensitive methods for characterizing their products; the challenge has become choosing the right combination of methods, and balancing the risk of not detecting a material change in the product with the time and expense associated with extensive characterization.