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6 BioPharm International ® Emerging Therapies eBook September 2024 www.biopharminternational.com Cell and Gene Therapies are sky high, which have led to high price points, particularly in autologous cell therapies where pro- duction is 1:1. Automation is a key part of improving costs, reducing labor both in and outside the clean room, and implementing release by exception can help to reduce bottlenecks. Companies are trying to integrate unit operations whether it's an 'all-in-one- box' approach or a 'unit-operator' approach where units can be plugged in or out and are integrated within robotic systems to offer greater f lexibility." For instance, Lonza's Cocoon Platform and Miltenyi Biotec CliniMACS Prodigy offer an 'all-in-one-box' approach providing a closed, automated system for patient-scale cell therapy manufacturing from cell isolation, activation, transduction/transfection, ex- pansion, and harvest within a validated cell manu- facturing system (5,6). CliniMACS Prodigy modular Instruments can also be run in parallel to provide large-scale batch production. UK-based Ori Biotech launched its IRO platform de- veloped in 2024 in collaboration with CTMC (a joint venture between Resilience and MD Anderson Can- cer Center). This platform automates the activation, transduction, expansion, and harvest of a wide range of cell types to rapidly scale up manufacturing from the clinic to the commercial setting (7). Pa r is-ba sed Ast raveus SAS ha s developed t he Lakhesys Benchtop Cell Factory, an end-to-end solu- tion for the manufacture of adherent, non-adherent, and inducible pluripotent stem cells (iPSCs) (8). The company has raised €16.5 million in seed financing and received a €10.4 million grant from the French government as part of its "Innovation in Biotherapies and Bioproduction" initiative, to advance the devel- opment of its technology (9). Several companies are developing integrated biore- actors, robotic systems, and smart monitoring tech- nologies that can support a 'unit operator' approach. UK-based Cellular Origins, launched Constella- tion, a closed fully automated, and configurable ro- botic platform for CGT manufacture in 2023 (10). In May 2023, it forged a partnership with ScaleReddy (a joint venture between Bio-Techne, Fresenius Kabi, and Wilson Wolf) to automate its CGT manufactur- ing workf low using Cellular Origin's robotic system (11). According to Jason Jones, Global Business De- velopment lead, Cellular Origins, "Our company in- tegrates existing, proven technologies with mobile robotics to provide f ully automated factories that can be scaled up to manufacturers' requirements, minimize risks, and are GMP [good manufacturing compliance] compliant. We can achieve a 30-fold increase in space efficiency and manufacture and a 16-fold labour reduction, equating to a 51% reduction in cost-of-goods and enabling manufacture 24/7, 365 days a year." Sw i ss-ba sed L i mu l a h a s t a ken a d i f ferent ap- proach and developed a modular solution that com- bines a bioreactor and centrifuge into one device for on-demand and at-scale manufacturing of cell ther- apies (12). In May 2024, the company raised CHF 6.2 million (US$6.8 million, €6.24 million) in seed fund- ing to develop its automated CGT manufacturing platform, the f unding round was over-subscribed high lighting the interest that venture capita lists have in this field (13). UK-based Microf luidX has developed a space-sav- ing stackable multi-bioreactor instrument—the Cyto Engine Stack. Each bioreactor can be controlled and monitored independently, to allow cell therapy man- ufacturers to expand their manufacturing capacity without increasing the facility footprint. The first Cyto Engine product is scheduled for launch in early 2025 (14). O t her compa n ies h ave foc u sed on le verag i ng digital tools and advanced analytics to streamline the manufacturing process. For instance, UK-based Autolomous has launched AutoloM ATE Launch- pad, a cloud-based CGT platform that allows for the sca labi lit y and adaptabi lit y of dif ferent CGT mo- dalities (15). According to Alexander Seyf, the CEO of Autolomous, "Addressing manufacturing chal- lenges ef fectively demands a sh if t towards more integrated and automated systems. By leveraging d igita l tools a nd adva nced a na ly t ics, we ca n en- hance process control, increase reproducibility, and reduce labour-intensive procedures which, in turn, decrease costs significantly. Moreover, digitization can streamline data f low across the manufacturing process, ensuring that critical information is acces- Several companies are developing integrated bioreactors, robotic systems, and smart monitoring technologies that can support a 'unit operator' approach.