Mar 26Sponsor's Roles & Responsibilities in Batch Review & DispositionHere is a general guideline for a Sponsor's review of GMP batch records for release to clinic for human studies.
Feb 11Ensuring all the Puzzle Pieces Fit in Your Biologics Program: Technical CMC Project ManagementIn a perfect biologics manufacturing world, a Sponsor would be able to sign a contract with an experienced CDMO and voilà ...
Jan 16The "Form" in Formulation DevelopmentEmbarking on a product development program initiates (among a multitude of other facets) the management of a dynamic interplay between