In 2022, the number of newly approved biologic drugs outpaced that of small molecules for the first time (1). Notably, almost a third of the new approvals comprised novel modalities, such as cell and gene therapies, antibody–drug conjugates, and bispecific proteins. In fact, a report forecasted biologics sales to exceed that of small molecules drugs by 2027 (2). The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.
