Single-Use Technology in Purification of Monoclonal Antibiotics
Hrishikesh S Bharadwaj*, Siddharth Kaushik L S, Snigdha Tutika
Department of Biotechnology, R V College of Engineering, Mysore Road, Vidyaniketan Post, Bangalore 560059
*Corresponding author
Department of Biotechnology
R V College of Engineering
Mysore Road, Vidyaniketan Post
Bangalore 560059
Email: hrishibharadwaj230@gmail.com
Abstract
The advent of Single-Use Technologies (SUT) has revolutionized biopharmaceutical manufacturing, offering a flexible and efficient alternative to traditional methods. This paper explores the diverse applications of SUT, focusing on therapeutic plasma filtration, clarifying processes, virus removal strategies, and chromatography solutions. Highlighting the advantages such as convenience, reduced contamination risk, and streamlined processes, the document delves into the economic and environmental impacts of adopting SUT. Despite challenges in scalability and automation, specific examples like Immusorba PH-350 and Pall Biotech's AllegroTM underscore the significant adsorption efficiency achieved with single-use systems. Anticoagulation strategies tailored for single-use plasma filtration contribute to optimal systemic performance. The dynamic market for disposable devices, featuring prominent manufacturers like Fresenius HemoCare, Kaneka, Medicap Clinic GmbH, Miltenyi Biotec, Toray Medical, and Biotex, reflects the widespread adoption of SUT across various medical applications. The ongoing innovation in overcoming scalability limitations and the commitment to standardization position SUT as a transformative force in modern biopharmaceutical manufacturing. In conclusion, the economic implications and positive environmental impact underscore SUT's potential to shape the future of the industry.
Keywords: Single Use Technology, Reduced Contamination, Antibiotics, Biopharmaceutical, Good Manufacturing Practices, Mixing bag, Aseptic Connections, Single use Bioreactors, Disposable Chromatography Columns, Single use Filtration, Running Cost, Labour charges
