Issue link: https://www.e-digitaleditions.com/i/1492687
16 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com RGTIMELINE - STOCK.ADOBE.COM S ince biological drugs first became avail- able, their demand has been increasing— with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With advancements in research and technologies, the di- versity of biological drugs available is broad, includ- ing monoclonal antibodies (mAbs), prophylactic vac- cines, gene therapy viral vectors (mainly lentivirus and adeno-associated virus), cell therapies (e.g., chi- meric antigen receptor T-cell therapy and modified stem cells), and oncolytic viruses (e.g., adenoviruses, herpes viruses, and vaccinia virus). As a result, the bioreactor vendor and contract devel- opment and manufacturing organization industries are under pressure to increase production scale. To meet demand, these industries must feasibly scale up while considering safety, manual operator han- dling, engineering, infrastructure, costs, and finally biological processing itself. I n p a r a l le l w it h t h i s i nc r e a s i n g d e m a n d f or production power is the rise in the integration of single-use technologies (SU Ts) into upstream and dow nstream manufact uring operations for bot h clinical development and commercial supply. Avail- able SU Ts i nclude bioreac tors, med ia a nd buf fer preparations, in-process mixing and liquid storage, amongst others. Their increased adoption is primar- ily driven by the many advantages offered by SUTs: • Reducing early capital investment • I ncrea si ng m a nu fac t u r i ng a nd operat ion a l Scaling Manufacturing Processes Using Single-Use Technologies Kai Lipinski, PhD, is the chief scientific officer of Vibalogics. Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.