The Hwasun plant will provide a comprehensive manufacturing capability to handle all stages of mRNA production. Credit: metamorworks / Shutterstock.com.

GC Biopharma has concluded construction activities at a new messenger ribonucleic acid (mRNA) manufacturing plant at its vaccine production site in South Korea.

Located at Hwasun, Jeollanam-do, the new plant will become operational early in 2024.

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The establishment of a new good manufacturing practices pilot plant is part of GC Biopharma’s plan to internalise several mRNA-linked technologies while strengthening related expertise.

The Hwasun plant will provide a comprehensive manufacturing capability to handle all stages of mRNA production.

This approach can cut down transfer-linked contamination issues and permit a quick manufacturing response.

The plant also features a single-use manufacturing unit, which will aid in reducing the risk of cross-contamination and facilitate the production of a number of products simultaneously.

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GC Biopharma research and development (R&D) head Jae Uk Jeong stated: “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.”

The company has been working in the mRNA field as one of its new drug development platforms. In 2022, it entered a lipid nanoparticle (LNP) development and option deal with Acuitas Therapeutics and subsequently set up an mRNA-LNP platform.

GC Biopharma is now leveraging this platform to develop a treatment for the rare disease succinic semialdehyde dehydrogenase deficiency, and mRNA influenza vaccine.

It plans to manufacture drugs for clinical trials in the new plant by utilising the technologies and expertise gained at the new mRNA production facility.

Plans are also in place to commercialise such drugs and enter the field of contract manufacturing organisation.

In August 2023, GC Biopharma signed a memorandum of understanding with Eubiologics to co-produce an oral cholera vaccine, Euvichol.

Eubiologics agreed to manage the bulk vaccine manufacturing while GC Biopharma will conduct the packaging process including the bottling of vials.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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