Thomas A. Little

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

Statistical methods to identify critical process parameters and critical material attributes-and approaches to control them-are needed to protect drug product and drug substances.