ABSTRACT
Photo courtesy of: DASGIP
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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.
