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20 BioPharm International ® Emerging Therapies 2022 eBook www.biopharminternational.com must occur for a single therapeutic dose. If the cen- tralized manufacturing model is scaled out to meet the demand of a large patient population, it's likely the logistic interactions will become unsustainable and further add to therapeutic costs. If autologous cell therapy continues to comprise a significant por- tion of cell therapies, other manufacturing models must be evaluated. Moving towards decentralized manufacturing One answer to efficiently manufacture autologous cell therapies at scale is adopting a hub-and-spoke de- centralized manufacturing model in which therapeu- tic developers partner with contract development and manufacturing organizations (CDMOs) who manage decentralized manufacturing networks to efficiently manufacture therapies. In principle, manufactur- ing hubs would be located in strategic geographical locations where they can manage multiple spokes and be utilized for early-phase clinical cell therapy ma nufact ur i ng, com mercia l cel l t herapy ma nu- facturing (primarily allogeneic products), housing quality personnel who release drug products to pa- tients. The manufacturing spokes primary tasks are manufacturing cell therapies and performing quality control (QC) release testing. The release test data package would be sent to the manufacturing hubs for review and release. Additionally, when organi- zations place spokes in strategic locations based on where therapies need to be distributed, the facilities are closer to the point-of-care and significantly sim- plify shipping logistics while reducing vein-to-vein times. This partnership model also serves to adjust manufacturing demand for therapeutic developers because curative therapies have different demand curves than maintenance therapies. While therapeutic developers can build their own manufacturing networks, considerations such as facil- ity size, utilization rate, and costs can pose significant challenges. Both capital expenditure costs and oper- ational expenses cannot be overlooked, especially in the current environment where talent is tight. By part- nering with CDMOs, developers gain the knowledge CDMOs have gleaned from prior experience as well as access to GMP manufacturing facilities while shedding any facility, staffing, and maintenance responsibilities. Cell and gene therapies continue to show promising results in multiple modalities. For cell and gene thera- pies to reach their full potential, changes in manufac- turing must be explored to lower costs and improve product consistency which will ultimately increase patient adoption. Reference 1. Research and Markets, Cell & Gene Therapy Market– Global Outlook & Forecast 2022–2027, January 2022. ■ Drug Digest: Development and Scalability of ADCs and CGTs Drug Digest, a tech talk with BioPharm International's sister publication's, Pharmaceutical Technology, editors, discusses emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the re- search, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. In this exclusive Drug Digest video, editors Meg Rivers and Feliza Mirasol interview experts in cell and gene therapies and antibody-drug conjugates. Specifically, they discuss the factors that could influence an organization to pursue specific biomolecules for development; key considerations for scalability; capacity issues; trends; chemistry manufacturing and controls; and how to ensure consistency and reproducibility. Experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development. Featured in this video are Lisa McDermott, director of Process and Analytical Development Global Contract Manufacturing Services, MilliporeSigma, the US and Canadian Life Science business of Merck KGaA Darmstadt, Germany, and Jasna Curak, Global Quality and External Collaboration Manager, Hoffmann-La Roche Ltd. Visit PharmTech.com/drug-digest for more videos on a variety of bio/pharmaceutical manufacturing topics. —The editors of BioPharm International