GC Biopharma , a South Korean biopharmaceutical company, announced that it has completed the construction mRNA (messenger ribonucleic acid) production facility in its own vaccine production plant in Hwasun, Jeollanam-do, Korea, and will soon start the operation.
The production facility is a GMP pilot plant that will support the company's strategy to internalize various mRNA-related technologies while continuously building up related capabilities.
The new facility offers an "all-in-one" production capability that accommodates all phases of mRNA production. It can, therefore, significantly reduce the contamination risk of transfer and allows prompt production response. In addition, the pilot plant has a "single-use" production facility that will reduce the cross-contamination risk and enable the production of multiple products at once.
Taking the mRNA as one of its new drug development platforms, GC Biopharma has been putting efforts in this area by signing the lipid nanoparticle (LNP) development and option agreement with Acuitas Therapeutics last year and establishing a new mRNA-LNP platform this year. It is now actively making R&D efforts to advance into a clinical stage. Currently, this platform is being applied to develop treatment for SSADHD, one of the rare diseases, as well as mRNA influenza vaccine.
Based on the technologies and capabilities it would accumulate in the new mRNA production facility by testing the effectiveness and safety of various vaccines and treatment candidates, the company is planning to produce drugs for clinical trials in the GMP pilot plant with a roadmap to move on to commercialization and further to CMO business.
Jae Uk Jeong, Head of R&D at GC Biopharma said, "Construction of the new production facility was a part of our project to move ahead in securing the mRNA platform technology. We expect the facility to be widely used in various joint R&D and responses to any future pandemics."