Developments and opportunities in continuous biopharmaceutical manufacturing

• Published in: mAbs Vol. 13; no. 1; p. 1903664
• Main Authors: Khanal, Ohnmar, Lenhoff, Abraham M.
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 01-01-2021; Taylor & Francis Group
• Subjects: Biological Products - economics; Biopharmaceuticals; bioprocessing; Biosimilar Pharmaceuticals - economics; biosimilars; Biotechnology - economics; chromatography; continuous manufacturing; Cost-Benefit Analysis; Drug Costs; Drug Industry - economics; filtration; Humans; monoclonal antibodies; perfusion culture; process analytical technology; Review; Technology, Pharmaceutical - economics; Time Factors; viral inactivation; Workflow; viral inactivation; bioprocessing; filtration; process analytical technology; perfusion culture; biosimilars; chromatography; continuous manufacturing; Biopharmaceuticals; monoclonal antibodies
• ISSN: 1942-0862; 1942-0870; 1942-0870
• DOI: 10.1080/19420862.2021.1903664

Today's biologics manufacturing practices incur high costs to the drug makers, which can contribute to high prices for patients. Timely investment in the development and implementation of continuous biomanufacturing can increase the production of consistent-quality drugs at a lower cost and a faster pace, to meet growing demand. Efficient use of equipment, manufacturing footprint, and labor also offer the potential to improve drug accessibility. Although technological efforts enabling continuous biomanufacturing have commenced, challenges remain in the integration, monitoring, and control of traditionally segmented unit operations. Here, we discuss recent developments supporting the implementation of continuous biomanufacturing, along with their benefits.