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www.biopharminternational.com Emerging Therapies eBook September 2024 BioPharm International ® 7 Cell and Gene Therapies sible and actionable. This integration leads to im- proved decision-making, faster turnaround times, and ultimately, more standardized production of therapies." In 2024, US-based Cellares, became the first Inte- grated Development and Manufacturing Organiza- tion (IDMO) to offer a high-throughput fully, auto- mated smart manufacturing platform Cell Shuttle. In April 2024, the company signed a US$380 million (€349 million) supply agreement for the manufacture of chimeric antigen receptor-T cell therapies with Bristol-Myers Squibb, and it announced a similar agreement with Kite in June (16,17). The future of CGTs Over the next decade, the demand for CGTs is ex- pected to grow as they move f ur ther up the treat- ment cascade and target more common diseases. It will be essential for companies to address the chal- lenges associated with scaling up the manufactur- ing process to provide high-quality, consistent au- tologous and allogenic cell products while adhering to stringent regulatory standards. Fully automated space-saving modular technologies will allow man- ufacturers to steadily scale up capacity and adapt to demands (18). Smith notes, "CDMOs [contract development and manufacturing organizations] are looking at the tra- jectory of pipeline products and questioning where and when they need to invest in new facilities and technologies. Manufacturing is one of the biggest areas of risk in CGT developments, but if we can de- risk the process by deploying robust engineered man- ufacturing processes and automation, we can reduce the cost of autologous cell manufacture and increase the speed and flexibility to meet individual needs. On the allogenic side, the processes tend to be on a larger scale, and the drug product cost is shared amongst many patients. Although automation can assist in cost reduction, the burden is less steep than for au- tologous, that said, many of the same automation tools can be used across processes, and the industry is looking to standardize manufacturing." In the longer term, the industr y could move to- wards a more decentralized manufacturing model that utilizes automated point-of-care technologies to enable on-site preparation of CGTs in or near hos- pitals, helping to bring therapies closer to the patient. "The current acute unmet need is on scaling cen- tra lized systems, but we've had some interesting conversations around decentralization negating op- erator variability/increasing process comparability and digitalization of information of the product and opening up facilities at the national, regional, and near-hospital levels depending on the therapy and medical need," observes Jones. References 1. Citeline, Gene, Cell, and RNA Therapy Landscape Report. Q1 2024 Quarterly Data Report. Apr. 11, 2024. 2. Harrison, P.T., Friedmann, T. Correction: Cost of Gene Therapy. Gene Therapy, 2024, 31, 195-196. 3. Batty, R. Closed, Automated Cell Therapy Manufac- turing–Is Your Facility Ready? TechTalk, NNE.com. May 8, 2022. 4. Harris, R. Cell Therapy Manufacturing Shifts to Auto- matic. Genetic Engineering & Biotechnology News. Oct. 4, 2021. 5. Lonza. The Cocoon® Cell Therapy Manufacturing Platform. Lonza.com (accessed July 2024). 6. Miltenyi Biotec. CliniMACS Prodigy Instrument. miltenyibiotec.com (accessed July 2024). 7. Ori Biotech. Ori Biotech Unveils IRO Platform at An- nual International Society for Cell & Gene Therapy Conference. News Release. May 29, 2024. 8. Ast raveus. La k hes ys™ Benchtop Cel l Fac tor y - Astraveus - Enable a Healthier Tomorrow. astraveus. com (accessed July 2024). 9. PRNewswire. Astraveus Raises €16.5 Million Series Seed Round to Advance the Development of its Auto- mated, Microfluidic Cell and Gene Therapy Manufac- turing Platform. News Release. June 27, 2023. 10. Cellular Origins. Cellular Origins Launches Constel- lation™, Its Configurable Robotic Platform to Enable Scalable Manufacture of Advanced Therapies. News Release. May 31, 2023. 11. Cellular Origins. Cellular Origins Partners with ScaleReady to Simplify, Standardize, and Automate Cell Therapy Manufacturing. News Release. May 11, 2023. 12. Limula. The Future of Cell and Gene Therapy is Auto- mated. News Release. (accessed July 10, 2024). 13. Limula. Limula Raises CHF 6.2 Million in an Over- subscribed Seed Round to Develop an Automated Cell and Gene Therapy Manufacturing Platform. News Re- lease. May 21, 2024. 14. Microfluid. MicrofluidX Secures Innovate UK Award to Advance High Throughput. News Release. Dec. 19, 2023. 15. Autolomous. Autolomous Releases the CGT industry's First Free eBR Builder, autoloMATE Launchpad, to Em- power Digital Planning. News Release. May 29, 2024. 16. Cellares. Bristol Myers Squibb, and Cellares An- nounce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster. Press Release Apr. 22, 2024 17. Cellares. Cellares Announces Agreement with Kite to Evaluate Its Cell Shuttle Automated Manufacturing Platform. Press Release. June 27, 2024. 18. Spivey, C. Small Footprint Automated Closed Produc- tion Platforms for CAR-T and Other Advanced Thera- pies. Pharm. Technol., 2023, 47 (4) 28-30. Q