De-Risking Development: Characterization Analytics Case Studies

Reducing risk in biopharmaceutical development requires proactive strategies to address quality challenges before they escalate. Two real-world case studies demonstrate how advanced characterization analytics and mass spectrometry can safeguard timelines and budgets. In one example, peptide mapping identified and characterized C-terminal extensions as product-related impurities, enabling effective quality control measures early in development. Another case study highlights how LC-MS methods uncovered the root cause of polysorbate 80 degradation differences between manufacturing sites, preventing a potential BLA delay or even product failure.

These insights underscore the importance of investing in robust analytical method development early in the product lifecycle. Whether you are preparing for IND filing or scaling up for commercial manufacturing, understanding these approaches can help you anticipate and mitigate risks.

Gain practical strategies for identifying protein quality issues, uncovering manufacturing challenges, and reducing late-stage development risk through advanced characterization techniques.