Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance

PDA J Pharm Sci Technol. 2016 Sep 10;70(5):462-469. doi: 10.5731/pdajpst.2016.006957. Epub 2016 Aug 11.

Authors

Rachel Specht¹, Meisam Bakhshayeshi²

Affiliations

¹ Process Virology/Purification Development Department. Genentech, a Member of the Roche Group, 1 DNA Way, MS10, South San Francisco, CA 94080; (650) 467-2372; specht.rachel@gene.com; and specht.rachel@gene.com.
² Senior Engineer, Biogen, 225 Binney Street, Cambridge, MA 02142; (617) 679-3264; meisam.bakhshayeshi@biogen.com.

PMID: 27516486
DOI: 10.5731/pdajpst.2016.006957

No abstract available

MeSH terms

Drug Industry
Kinetics
Quality Control
Viruses / isolation & purification*