The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The book highlights the significant advancements in molecular medicines, noting that around 50 new drugs are approved annually by the FDA, with 25% being biopharmaceuticals. It details the introduction of over 200 recombinant proteins and monoclonal antibodies, as well as more than 60 biosimilars. Additionally, it discusses the rise of gene therapies using engineered viruses and cells. The comprehensive list of over 400 CMC regulatory compliance references, updated since the third edition, underscores the rapid evolution in this field.