GC Biopharma, a biopharmaceutical company based in South Korea, has successfully completed the construction of an mRNA (messenger ribonucleic acid) production facility within its vaccine production plant located in Hwasun, Jeollanam-do, Korea. The facility is poised to commence operations shortly.
Designed as a Good Manufacturing Practice (GMP) pilot plant, this production facility aligns with GC Biopharma's strategic goal of internalizing various mRNA-related technologies while consistently enhancing associated capabilities. Offering an "all-in-one" production capability, the facility covers all phases of mRNA production, thereby substantially reducing the risk of contamination during transfer and facilitating rapid production response. Additionally, the pilot plant features a "single-use" production facility, mitigating cross-contamination risks and enabling the simultaneous production of multiple products.
GC Biopharma has identified mRNA as a key focus for new drug development platforms. In the past year, the company has made significant strides in this domain, including entering into a lipid nanoparticle (LNP) development and option agreement with Acuitas Therapeutics. This year, GC Biopharma established a new mRNA-LNP platform and is actively engaged in research and development efforts to advance into the clinical stage. The platform is currently applied to develop treatments for SSADHD, a rare disease, and an mRNA influenza vaccine.
Drawing on the technologies and capabilities accumulated in the new mRNA production facility through testing various vaccines and treatment candidates for effectiveness and safety, the company plans to manufacture drugs for clinical trials in the GMP pilot plant. This initiative is part of a broader roadmap that includes progression to commercialization and eventual expansion into Contract Manufacturing Organization (CMO) business ventures.
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