The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment Presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing Revised 2nd Edition is broadened to include biopharmaceuticals (biotech drugs) and other biologics (vaccines, cell therapy, plasma-derived proteins, etc.) Includes supplementary material: sn.pub/extras