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20 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com MULTIMODAL Much of t h is burgeon i ng i nterest stem s f rom t h e s u b s t a n t i a l v a l u e t h a t c a n b e u n l o c k e d b y i m ple me nt i n g t h i s t y p e of m a nu f a c t u r i n g approach. For example, a growing number of CMOs a re developi ng pla sm id produc t ion capabi l it ies to s upp or t t he i r m R NA m a nu f ac t u r i n g ne e d s. Simultaneously, they are establishing themselves as t h i rd-pa r t y suppl iers of plasm ids to exter na l c u s tomer s, f u r t her d iver si f y i ng t hei r re venue streams. S e ver a l f ac tor s a re d r iv i ng t h i s moment u m. Mu lt i mo d a l m a nu f a c t u r i n g pl a t f or m s c a n b e designed with f lexibility in mind, allowing for the incor poration of new processes or modif ications to existing processes as scientific understanding advances. Consolidating multiple manufacturing s teps a nd tech nolog ies w it h i n a si ng le f ac i l it y translates into enhanced overall process efficiency, potentia lly reducing costs associated with labor, equipment, and materials. Additionally, multimodal m a nu f a c t u r i n g e ncou r a ge s c r os s- d i s c ipl i n a r y col l aborat ion , en abl i ng e x per t s f rom d i f ferent disciplines to contribute t heir k nowledge to t he development of a unified manufacturing operation. Other driving factors include speed to market as mu lt i mod a l m a nu f ac t u r i ng ca n accelerate t he production timeline by eliminating bottlenecks and inefficiencies that may arise when using disparate manufacturing processes. I n conclu sion , mu lt i mod a l m a nu fac t u r i ng i s becoming a cornerstone of the ATMP manufacturing l a n d s c a p e , d r i v e n b y i t s i n h e r e n t v a l u e a n d ad apt abi l it y. A s i ndu s t r y leader s i nc rea si ng ly harness its potential, it promises to propel the ATMP sector toward greater efficiency, innovation, and responsiveness to evolving market demands. References 1. The White House. Bold Goals for US Biotechnol- ogy and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. White House, Executive Order 14081, March 2023. 2. Vision Research Reports. Cell and Gene Therapy Mar- ket (By Therapy Type: Gene Therapy, Cell Therapy; By Application: Oncology, Genetic Disorders, Dermatology Disorders, Musculoskeletal Disorders, Others; End-Us- ers: Hospitals, Cancer Care Centers, Wound Care Cen- ters, Others)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2022- 2030. Market Research Report, July 2022 3. Witcher, M.F.; Carbonell, R.; Odum, J.; et al. Facil- ity of the Future: Next Generation Biomanufactur- ing Forum Parts I, II, III. Pharmaceutical Engineering 2013, 33 (1–3). 4. Kemp, J. A.; Shim, M. S.; Heo, C. Y.; Kwon, Jik, Y. "Combo" Na nomed ici ne: Co-Del iver y of Mu lt i- Modal Therapeutics for Efficient, Targeted, and Safe Cancer Therapy. Advanced Drug Deliver y Re- views 2016, 98, 3–18. DOI: 10.1016/j.addr.2015.10.019 5. Odum, J.; Flickinger, M. C., Eds. Product–Process– Facilit y R elat ionship. In P rocess A rchitect ure in Biomanufacturing Facility Design; Wiley and Sons, 2018; pp. 39–54. 6. Genesis AEC. Technical Opinion: Applicabilit y of Recirculated Air for ATMP Products in Grade B/ISO 7 and Grade C/ISO 8. www.genesisaec.com, March 2022. 7. Occupational Safety and Health Administration. OSHA Standards, 1910.106, subpart H, Flammable Liquids. www.osha.gov (accessed Nov. 28, 2023). 8. Walters, P.; Maestre, N. Four Design Factors Shap- ing Multimodal Cell and Gene Manufacturing. Bi- oProcess International online, June 18, 2021. ■ FIGURE . Survey results. GMP is good manufacturing practice.