The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The book provides an in-depth overview of the significant advancements in molecular medicines, highlighting the annual approval of around 50 new drugs by the FDA, with a notable 25% being biopharmaceuticals. It details the extensive range of products available, including recombinant proteins and monoclonal antibodies, along with the emergence of over 60 biosimilars. Additionally, it discusses the rise of gene therapies utilizing engineered viruses and cells. The text also features over 400 updated CMC regulatory compliance references, reflecting the evolving landscape of the pharmaceutical industry.