Issue link: https://www.e-digitaleditions.com/i/1517802
4 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com mailsonpignata - Stock.adobe.com T he adoption of single-use technologies (SUTs) in biopharmaceutical manufacturing reduces manufacturing costs, increases the manufacturing line flexibility, and improves the speed and efficacy of the line changeovers or the batch turnaround times. The closed manufacturing systems also facilitate production of a safe and regu- latory-compliant product. SUTs are used throughout the biopharma manufacturing process flow, the sin- gle-use filter capsules, tubing, and connectors being the most widely used in the final fill/finish applica- tions of the injectable preparations. The single-use bioreactor bags and buffer storage bags are used for upstream applications. This paper reviews the drivers for adoption of SUTs and how the risks from the use of these technologies can be overcome in a planned, proactive, and compliant manner. The adoption of single-use components emerged from the mid-1980s. Initially, blood bags replaced glass bottles and soon became available with a plas- tic tube or two as well as connectors, valves, and vials for taking biological samples. The polyvinyl chloride blood bags used for blood donations were more than just bags. Evolving from these examples are the cur- rent single-uses systems (SUS) that are gaining wider use in the biopharmaceuticals industry, especially for the production of specialized and/or small-batch biopharmaceutical drugs. These SUS are the alter- natives to the systems made of relatively inf lexible stain less-steel vessels and reactors, hard piping, Review of SUT Adoption in Biopharma Manufacturing Ramesh Raju Mavuleti * , rrajum@gmail.com, is head of operations, Validation Services India, at Merck Life Sciences Pvt, Ltd.; K. Vasantakumar Pai, PhD, is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University; K. Sreedhara Ranganath Pai, PhD, is professor, Department of Pharmacology, at Manipal Academy of Higher Education; Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC, at Merck Life Sciences Pvt, Ltd.; Somasundaram Gopalakrishnan is senior consultant, Global Biopharm Center of Excellence, at Merck Pte. Ltd.; and Tathagata Ray is consultant, Global Strategy Deployment, at Merck Life Sciences Pvt, Ltd. * To whom all correspondence should be addressed. The evolution of therapeutic modalities drives the adoption of single-use technologies.