This book highlights the challenges facing quality assurance/quality
control (QA/QC) in today's biopharmaceutical environment and presents
the strategic importance and value generated by QA/QC for their
involvement in control of manufacturing. It will put into perspective
the need for a graded approach to QA/QC from early clinical trials
through market approval. Since the first edition published in 2004,
there have been more than 50 new regulatory guidances released by the
Food and Drug Administration (FDA), European Medicines Agency (EMA) and
ICH that affect the CMC regulatory compliance of biopharmaceuticals;
also the application of biosimilars has been developed in Europe and is
under development in the USA. The revised update will be broadened to
include not only biopharmaceuticals (biotech drugs) but also other
biologics (vaccines, cell therapy, plasma-derived proteins, etc.)