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Robert Crofton
Manager, CMC Development, Biologics Syner-G BioPharma Group
Robert Crofton has been a consultant with Syner-G for over 2 years. With 12 years of experience in the biopharmaceutical industry, he has worked in the manufacture and development of protein-based biologics, including downstream process development, analytical method development and validation, statistical analysis, and regulatory writing. He assisted writing the approved biologic license application for the drug RYPLAZIM, an orphan drug used to treat type I plasminogen deficiency.
Robert Crofton's Recent Articles
Navigating the Evolution from ICH Q2(R1) to ICH Q2(R2) and Implementation of ICH Q14 in Biopharmaceutical Method Validation
In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…