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18 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com S ince biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximate- ly US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound an- nual growth rate of 9.06% (1). With advancements in research and technologies, the diversity of biological drugs available is broad, including monoclonal antibod- ies (mAbs), prophylactic vaccines, gene therapy viral vectors (mainly lentivirus and adeno-associated virus), cell therapies (e.g., chimeric 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. In parallel with this increasing demand for produc- tion power is the rise in the integration of single-use technologies (SUTs) into upstream and downstream manufacturing operations for both clinical develop- ment and commercial supply. Available SUTs include bioreactors, media and buffer preparations, in-process mixing and liquid storage, amongst others. Their in- creased adoption is primarily driven by the many ad- vantages offered by SUTs: • Reducing early capital investment • Increasing manufacturing and operational flexibil- ity (modular design) • Reducing total footprint • Shortening campaign turnover times • Decreasing operating costs • Minimizing cross-contamination risk • Enabling simple installation • Offering a design that is beneficial for closed pro- cessing operations • Avoiding costly, laborious, and time-consuming 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. RGTIMELINE - STOCK.ADOBE.COM