Technical / White Paper
Strategies and tactics for success in biologics analytical testing
The biopharma landscape is forever changing, and with it, a demand from both patients and investors for the rapid development and progression of drug products to market. Analytical testing is a crucial part of this process and must be carefully considered when striving for a speedy development timeline while maintaining safety for patients.
Well-designed analytical testing of biologics is essential during every stage of biopharmaceutical development to ensure the safety and quality of the drug and provides an important feedback loop during development. The complexity of biologics means meeting the stringent regulations surrounding their approval is often more challenging than small molecule therapeutics, emphasizing the importance of a robust approach to their analysis.
