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Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
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.
Read this article in BioPharm International's 2018 Outsourcing Resources eBook.
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eBook: Outsourcing Resources 2018
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).