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www.biopharminternational.com Next-Generation Biotherapeutics April 2025 BioPharm International ® 19 Industry Update candidates against high-value targets, and other novel targets still in the discovery stage. I n M a r c h , B e l g iu m-b a s e d Q u a nt o om Bios c i- ences an nounced it would be col laborating w it h TechInvention Lifecare Pvt. Ltd. for the accessibility, scalability, and affordability of RNA-based vaccines. This pact also extends to animal and environmental health with environmentally sustainable technology integrating modular, low-carbon-footprint messen- ger RNA (mRNA) systems that suppor t decarbon- ization and efforts to provide access to next-gener- ation RNA technologies (5). Later in March, Cytiva announced it is expanding its Xcellerex X-platform portfolio by adding 500-L and 2000-L bioreactors, al- lowing scientists and researchers to more easily scale up manufacturing of next-generation advanced ther- apeutics, ultimately lowering costs, reducing risks, and speeding time to bring new therapeutics to the next clinical milestone (6). Innovation in the face of uncertainty Much of the business of the bio/pharmaceutical in- dustr y early in 2025 has been conducted through the lens of the threat of high tariffs being imposed by United States President Donald Trump's admin- istration. Eli Lilly and Company announced on Feb. 26, 2025 that it would be building four new manu- facturing sites in the US "to deliver on our big bets on next-generation modalities like small molecules, biologics, and nucleic acid therapies," Edgardo Her- nandez, executive vice president and president of Lilly Manufacturing Operations, said at the time (7). In the first edition of BioPharm International®'s "Piv- otal Paper" series, vaccine experts discussed a study published in early 2025 in Nature Communications. This study, the first to report on clinical use of next-gen- eration optimized self-replicating RNA (srRNA) tech- nology, proposed an srRNA platform with optimized non-coding regions that demonstrated immunogenic- ity and safety of a rabies vaccine, in healthy volunteers, in preclinical and clinical development (8,9). "Up to now there's been some uncertainty about the prospects. If the technolog y could be making high quality [drug product], could we make it potent enough?" Jeffrey Ulmer, PhD, president of TechIm- mune LLC, said in the "Pivotal Paper" installment (8). "I think what this paper clearly demonstrates is ... the technology has arrived." Outlook for the rest of 2025 Looking into the second quarter, Sai Life Sciences announced on Apri l 3, 2025 t he launch of a new, dedicated peptide research center housed on its in- tegrated R&D campus in Hyderabad, India, which CEO and managing director Krishna Kanumuri said would "reinforce our role as a trusted partner in ad- vancing next-generation therapeutics" (10). The same day, a research collaboration was disclosed between UK-based Entos Pharmaceuticals and Norway-based Circio Holding, which specializes in circular RNA technology for next-generation nucleic acid medi- cines, under which Entos will develop and validate proteolipid vehicle formulations of Circio's circular RNA expression vectors (circVec) DNA vectors (11). The pace of collaboration and innovation in bio- therapeutics is already rapid, and getting faster. So, when the next generation after the next generation may begin could happen sooner than you think. References 1. Mirasol, F. Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development. PharmTech.com, Dec. 20, 2024. 2. Bora Pharmaceuticals. Bora Biologics Announces Strategic Collaboration to Accelerate Key CMC De- velopment of DotBio's Tri-Specific Antibody to Treat Cancer. Press Release. Jan. 9, 2025. 3. Coave Therapeutics. Coave Therapeutics Secures €32 Million ($33 Million) in Series A Financing to Advance its Next-Generation Genetic Medicines. Press Release. Jan. 9, 2025. 4. Telix Pharmaceuticals. Telix to Acquire Next-Gen- eration Therapeutic Assets and Innovative Biologics Technology Platform. Press Release. Jan. 13, 2025. 5. Quantoom. India and Belgium Unite to Advance RNA-Based Vaccines: MoU Signed Between Techin- vention and Quantoom Biosciences, in the Presence of Her Royal Highness Princess Astrid of Belgium During t he Belgian Economic Mission to India. Press Release. March 5, 2025. 6. Cytiva. Cytiva Broadens Xcellerex X-platform to In- clude 500 L and 2000 L Bioreactors. Press Release. March 25, 2025. 7. Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025 8. Spivey, C.; Dormitzer, P.; Felgner, P.; et al. The First Optimized Self-Replicating RNA (srRNA) Technol- ogy. BioPharmInternational.com, March 21, 2025. 9. Maine, C. J.; Miyake-Stoner, S. J.; Spasova, D. S.; et al. Safet y and Immunogenicit y of an Optimized Self-Replicating RNA Platform for Low-Dose or Single-Dose Vaccine Applications: A Randomized, Open-Label Phase I Study in Healthy Volunteers. Nat. Commun. 2025, 16 (456). DOI: 10.1038/s41467- 025-55843-9 10. Sai Life Sciences. Sai Life Sciences Sets Up Peptide Research Center in India. Press Release. April 3, 2025. 11. Entos Pharmaceuticals. Entos & Circio Collaborate on In Vivo PLV-Circ vec Deliver y. Press Release. April 3, 2025. ■