Securing Production Capacity of 720 Million mRNA Vaccine Doses
Expanding Product Range and Production Capacity with Modular Factory Design
[Asia Economy Reporter Park Hyungsoo] The corporate value of Ilyeon Pharmaceutical is soaring day by day. This appears to be due to a revaluation movement following Ilyeon Pharmaceutical's securing of large-scale biopharmaceutical production capacity with the completion of its Chungju bio factory.
At 10:04 a.m. on the 6th, Ilyeon Pharmaceutical was trading at 66,900 KRW, up 12.63% from the previous day.
Ilyeon Pharmaceutical's market capitalization has exceeded 1.2 trillion KRW.
At the end of last month, Ilyeon Pharmaceutical completed the construction of the Chungju bio factory for the production of biopharmaceuticals such as gene and cell therapies and began preparations for Good Manufacturing Practice (GMP) certification. Ilyeon Pharmaceutical plans to promptly conduct qualification evaluation/validation and GMP certification to fully operate the production facilities of the Chungju bio factory. The goal is to develop it into a global biopharmaceutical production hub.
Worldwide, most gene and cell therapy CMO companies have been small-scale facilities producing clinical-stage materials. The number of production facilities was also limited. Until the first approval of mRNA therapeutics last year, most gene therapies remained in the clinical stage, and unlike antibody therapeutics, there was no demand for large-scale production facilities reaching commercialization.
Recently, globally, the value of gene and cell therapy production companies has risen further due to scarcity, as exemplified by Company A, which produces pDNA overseas and was acquired for $9.6 billion (approximately 10 trillion KRW).
The Ilyeon Pharmaceutical Chungju bio factory, located in Daesowon-myeon, Chungju-si, Chungcheongbuk-do, was completed over about four years from September 2017 to June 2021, with a total budget of 80 billion KRW invested.
The Chungju bio factory is a large-scale commercial production plant for gene and cell therapies and is the only facility in Korea capable of 'one-stop' production from active pharmaceutical ingredients (Drug Substance) to finished pharmaceutical products (Drug Product) for gene and cell therapies, which is its greatest feature.
Specifically, it will be capable of mass production of plasmid DNA (pDNA), a gene therapy based on microbial fermentation, as well as mRNA, AAV-based vaccines and therapeutics utilizing pDNA, and bacteriophages.
The Chungju bio factory has biopharmaceutical raw material (Drug Substance) production equipment including 50L, 200L, and 500L multi-use bioreactors and a single-use 30L bioreactor. It also possesses the capability to simultaneously produce various substances through single-use bioreactors of 50L and 500L, the introduction timing of which is currently being coordinated.
For biopharmaceutical finished products (Drug Product), it has a production capacity of 48 million vials in liquid form and 9 million vials in lyophilized form. Based on mRNA vaccines, it is expected to produce 720 million doses annually. The Chungju factory is a modular plant with utility facilities already installed on spare land, so production items and capacity are expected to expand further with production line additions and expansions, according to the company.
Based on this production capacity, Ilyeon Pharmaceutical plans to conduct joint development and commercialization (securing exclusive production rights) with partners in the biopharmaceutical raw material (DS) business, and in the finished product (DP) business, it will also expand into the CDMO business. In addition to existing partner companies, it is currently discussing additional business cooperation with numerous domestic and international companies.
Yoo Yonghwan, CEO of Ilyeon Pharmaceutical, said, "In the biopharmaceutical market, venture companies based on substances have attracted market attention, while companies owning production facilities essential for actual commercialization of medicines have been relatively undervalued. Recently, due to issues such as COVID-19 vaccine production, companies with biopharmaceutical production facilities are gaining attention."
He added, "The Chungju bio factory's greatest strength lies in its linkage of production technology and know-how for 'microbial fermentation,' acquired through R&D and production of fermentation-based raw materials, to large-scale production from raw materials to finished products of plasmid DNA (pDNA), mRNA, and virus vector-based vaccines and therapeutics. We expect it to emerge as a global production hub in the gene and cell therapy market."
The completion ceremony of the Chungju bio factory has been tentatively postponed considering the COVID-19 situation. The company official stated that it plans to hold the ceremony together with the completion ceremony of Ilyeon Pharmaceutical's cGMP-grade Chungju chemical factory (scheduled for completion in March 2022), which is being constructed on the same site.
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