Assurance Of Clonality: A Key Regulatory Requirement For Biotherapeutics

Since the FDA’s approval of the first recombinant protein in 1986, the number of approved biopharmaceuticals has grown constantly over the years, reflecting their increasing relevance in modern medicine.¹ By 2021, the FDA approved the 100th monoclonal antibody product² together with nine other new biologic drugs, accounting for 16% of the total number of drugs approved that year.³ This 35-year pattern of steady growth in the biopharmaceutical market reflects how these drugs are one of the most effective clinical treatment modalities for a broad range of diseases; as a result, they are increasingly being used in almost all branches of medicine.⁴

The clonality of Master Cell Banks (MCBs) for production cell lines is a key requirement in biotherapeutics manufacturing. Learn how new devices help optimize the cloning process.