Gaining Analytical Insight in the Development of Biologics

Improvements in analytical technologies provide increased capabilities to examine proteins, cell lines, raw materials, and drug product throughout the drug development and manufacturing process. Regulatory expectations have also evolved. These new analytical requirements can tax the resources and technical capabilities of drug companies. 

Contract testing laboratories, which traditionally provided specialized testing services and expertise, are playing new roles in the current biopharmaceutical development market. To gain insight on what sponsor companies can gain from outsourcing their analytical processes, BioPharm International spoke with Jure Kapetan, managing director Eurofins BioPharma Product Testing D/A/CH; Wei Pan, director strategy and analytical CMC, development and analytical services at Catalent Pharma Solutions; and Michael Merges, director of strategic growth, biologics analytical services, at Catalent Pharma Solutions.

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Article Details

BioPharm International
eBook: Outsourcing Resources 2018
Vol. 31
March 2018
Pages: 30–32

Citation

When referring to this article, please cite it as S. Haigney, "Gaining Analytical Insight in the Development of Biologics," BioPharm International Outsourcing Resources eBook (March 2018).