Biophorum Extractables Requirements for Single-Use Systems. The Last Chapter.
Posted on October 26, 2020
James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy
Pall Biotech
Ken Wong, Deputy Director
Sanofi Pasteur
In May 2020, the Biophorum collaboration of biomanufacturers and suppliers published the highly anticipated update to the ‘Best Practices Guide for Extractables Testing of Polymeric Single-Use Components Using Biopharmaceutical Manufacturing’1. This consensus guidance for extractables testing, a...
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