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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2024 BioPharm International ® 19 T he adoption of single-use technologies (SUTs) in biopharmaceutical manufactur- ing reduces manufacturing costs, increases the manufacturing line flexibility, and im- proves the speed and efficacy of the line changeovers or the batch turnaround times. The closed manufac- turing systems also facilitate production of a safe and regulatory-compliant product. SUTs are used throughout the biopharma manufacturing process flow, the single-use filter capsules, tubing, and con- nectors being the most widely used in the final fill/ finish applications 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 bio- pharmaceutical drugs. These SUS are the alternatives to the systems made of relatively inf lexible stain- less-steel vessels and reactors, hard piping, valves, and so on. Such fixed systems must be cleaned and sterilized bet ween batches, a relatively labor and energy-intensive operation. The adoption of aseptic connectors, tubing, mixers, storage bags, and sam- pling bags and usage of capsule filters in a wide range of applications in the late 1990s lead to the "plastic factory" concept in the 2000s. The technology was further expanded to the upstream and downstream unit operations in the biopharma industry, such as the bioreactors, chromatography, virus removal fil- Review of SUT Adoption in Biopharma Manufacturing Ramesh Raju Mavuleti, K. Vasantakumar Pai, K. Sreedhara Ranganath Pai, Subhasis Banerjee, Somasundaram Gopalakrishnan, and Tathagata Ray The evolution of therapeutic modalities drives the adoption of single-use technologies. MAILSONPIGNATA - STOCK.ADOBE.COM