The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Each year for the past three years, there have been about 50 new  molecular medicines approved by the United States Food & Drug  Administration (FDA), of which approximately 25% were new  biopharmaceuticals. Over 200 recombinant proteins, monoclonal  antibodies, antibody drug conjugates, fusion proteins, and Fab fragments  are now in the marketplace in both the United States of America (USA)  and European Union (EU). There are also now over 60 biosimilars  available for all major classes of recombinant proteins and monoclonal  antibodies. In addition, gene therapies using genetically engineered  viruses and genetically engineered cells are now in the marketplace, and  continually growing. This degree of change is reflected in the over 400  CMC regulatory compliance references listed in this book that were  either issued or updated since the release of the third edition.

Deficiencies  in biopharmaceutical CMC regulatory compliance rarely result in  termination of a product, but in can readily cause months if not years  of delay in initiating clinical trials, or advancing clinical  development stages, or even market approval.

In summary, this book:
Updates  real-world CMC deficiency examples with current examples;Addresses  current FDA and EMA requirements and expectations for CMC regulatory  compliance;Now includes CMC regulatory compliance for the new gene-based  biopharmaceuticals.