Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs

• Published in: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals pp. 57 - 76
• Main Author: Geigert, John
• Format: Book Chapter
• Language: English
• Published: Switzerland Springer 2023; Springer Nature Switzerland
• Subjects: Biopharmaceuticals; Biosimilars; Cells; Chemical; Generics; Plasmids; Protein-based; Vector
• ISBN: 3031319087; 9783031319082
• DOI: 10.1007/978-3-031-31909-9_3

Regulatory compliance is essential for patient protection, and it applies both to Clinical as well as to Chemistry, Manufacturing & Controls (CMC). For CMC, there is no ‘one size fits all’ approach to regulatory compliance for all pharmaceutical types. Biopharmaceuticals are definitely different from chemical drugs. And among the different biopharmaceutical types there are major differences. This is not a perception, but a reality, accepted by regulatory authorities. In this chapter, four pharmaceutical types will be compared: (1) chemical drugs, (2) protein-based biopharmaceuticals – recombinant proteins and monoclonal antibodies, (3) viral vector biopharmaceuticals, and (4) genetically modified patient cells biopharmaceuticals. Four major CMC regulatory compliance areas will be examined: (1) non-living versus living source material, (2) impact of the manufacturing process on product consistency, (3) complexity of the manufactured product, and (4) biosimilars are not bio-generics. These differences emphasize the need for a risk-base approach toward CMC regulatory compliance to protect patients.