Single-use technologies in bio manufacturing: benefits and implementation challenges

Single-use technologies (SUT) have revolutionized the bio manufacturing industry by offering flexibility, cost efficiency, and improved contamination control. Initially adopted for simpler processes, SUT has expanded to complex bioprocessing operations, driven by the growing demand for biologics, vaccines, and personalized medicines. This review explores the benefits of SUT, including reduced capital and operational expenditures, faster setup and turnaround times, and enhanced product safety. The scalability of SUT allows for rapid adaptation to market demands, significantly accelerating the time-to-market for critical therapies. However, the implementation of SUT is not without challenges. Material compatibility, leachables, waste management, and supply chain reliability pose significant hurdles. Moreover, regulatory and validation challenges complicate the adoption of these technologies in large-scale production. Case studies, including the rapid deployment of COVID-19 vaccines and the production of monoclonal antibodies, illustrate SUT's practical applications and benefits. The review also examines future trends, highlighting advances in materials, automation, and digital integration, as well as the expanding applications of SUT in cell and gene therapy manufacturing. As the bio manufacturing landscape continues to evolve, SUT will play a crucial role in meeting the industry's growing needs, provided the challenges associated with its implementation are effectively managed.