May 167 Game-Changing Tips for a Successful Technology TransferMany biotechnology companies, as well as large pharma companies, use biologic Contract Development and Manufacturing Organizations (CDMOs)..
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...