Issue link: https://www.e-digitaleditions.com/i/1375981
10 BioPharm International eBook May 2021 www.biopharminternational.com Sagaer t (eTheRNA): There is a major difference between production of a biological for academic, clinical, or commercial purposes, especially in the expectations from regulators. The main differences lay not only in the documentation that needs to be avail- able, but on the level of control one needs to have over the processes, qual- ity control methods, and equipment. Furthermore, the product regula- tory requirements for control, testing, and characterization increase when moving from one clinical phase to another. A contractor needs to be able to leverage such increase in require- ments and be proactive to support a customer in this pathway. TIP OF THE RNA ICEBERG BioPharm: The current vaccine drive has boosted demand for RNA pro- duction and services in the industry of late, do you believe this trend will be the new normal and that RNA- based therapies will become mainstay products? R i c ke t t s (eT h e R N A ): Ac t u a l ly, we believe there is no new normal. R NA v acc i ne R & D a nd produc- tion for the COV ID-19 pandemic has established RNA as a new and v iable moda l it y, but t h is is rea l ly the tip of the iceberg. The range of applications of RNA as therapeutics and vaccines will grow signif icantly, and also, RNA plays a critical role in CAR-T and CRISPR-Cas9-based approaches. The need for RNA man- ufacture is only going to grow and will probably grow even beyond our own expectations. Sagaert (eTheRNA): RNA is a key stage in CR ISPR-Cas9-based gene editing and in CAR-T cell therapy. T he ubiqu itous need for R NA in these approaches, and as therapeu- tics and vaccines in themselves make RNA, means that the need for RNA manufacture is poised for significant growth. RNA provides a wide range of usage compared to other therapeu- tics. High variability in batch sizes of RNA will continue to be needed, even at commercial-scale manufac- turing, which can be challenging for a contract manufacturer. REFERENCES 1. Y-K. Kim, Chonnam. Med. J., 56 (2) 87–93 (2020). 2. Y. Cao and G.F. Gao, EClinicalMedicine, 32 (Feb.) 100746 (2021). 3. ReportLinker, RNA Therapy Market Research Report by Technology, by Application, by End User—Global Forecast to 2025—Cumulative Impact of COVID-19, Market Research Report (January 2021). 4. eTheRNA, "eTheRNA Extends mRNA Contract Manufacturing Services," Press Release, Nov. 3, 2020. 5. B.G. de la Torre and F. Albericio, Molecules, 25 (3) 745 (2020). BP Partnerships for Outsourcing Manufacturing Sanofi Acquires Tidal Therapeutics Sanofi acquired a US-based pre-clinical stage biotech com- pany, Tidal Therapeutics, in April 2021, gaining access to Tidal's novel messenger-RNA (mRNA) approach to in-vivo reprogramming of immune cells and broadening its re- search capabilities in immuno-oncology and inflammatory diseases (1). "We anticipate that this next-generation, off-the-shelf approach has the potential to bring CAR-T cell [chimeric antigen receptor T cell] therapy to a much broader patient population," said Frank Nestle, global head of Research and chief scientific officer at Sanofi, in an April 9, 2021 press release (1). "We believe that the underlying mRNA targeting platform will create disruptive therapeutic approaches across a variety of oncology and autoimmune conditions." BioNTech Expands Global Footprint German next-generation immunotherapy company, BioN- Tech, is expanding global operations with the establish- ment of a regional hub and mRNA manufacturing facility in Singapore (2). "With this planned mRNA production facility, we will increase our overall network capacity and expand our ability to manufacture and deliver our mRNA vaccines and therapies to people around the world," said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a May 10, 2021 press release (2). Lilly, MiNA Therapeutics Collaborate Eli Lilly and Company and MiNA Therapeutics, an RNA activation therapeutics company in the United Kingdom, are collaborating on novel drug development using Mi- NA's proprietary small activating RNA (saRNA) technology platform (3). "Small activating RNAs are a promising new technology, which will expand the breadth of Lilly's RNA therapeutics platform and the targets we can pursue," said Andrew C. Adams, PhD, vice-president for new therapeutic modalities at Lilly, in a May 11, 2021 press release (3). "We are excited about the potential of combining MiNA's leading saRNA platform and our expertise in new modalities to accelerate development of RNA-based medicines in areas of high unmet medical need." References 1. Sanofi, "Sanofi Acquires Tidal Therapeutics, Adding Inno- vative mRNA-based Research Platform with Applications in Oncology, Immunology, and Other Disease Areas," Press Release, April 9, 2021. 2. BioNTech, "BioNTech to Establish Regional Headquarters for Southeast Asia and First mRNA Manufacturing Facility in Singapore," Press Release, May 10, 2021. 3. Eli Lilly and Company, "Lilly and MiNA Therapeutics An- nounce saRNA Research Collaboration," Press Release, May 11, 2021. —The Editors of BioPharm International RNA-related industry news