With the completion of the construction of a bio plant in Chungju, REYON Pharmaceutical has gained large-scale biopharmaceutical production capacity.

REYON Pharmaceutical (co-CEOs Jeong Soon-ok and Yoo Yong-hwan) announced on June 29 that it had completed the construction of the bio plant in Chungju for the production of biopharmaceuticals such as gene and cellular therapy agents and begun preparing for GMP certification.

The company plans to start full-fledged operation of the production facilities at the Chungju bio plant after prompt qualification, validation, and GMP certification and turn the bio plant into a global biopharmaceutical production hub.

[A photograph of REYON Pharmaceutical’s Chungju bio plant taken by a drone (late June)] 
 
[A photograph of the entrance to REYON Pharmaceutical’s Chungju bio plant (late June)]  
 
[A photograph of Building C (offices and QC) of REYON Pharmaceutical’s Chungju bio plant (late June)]  

Contract manufacturing organizations (CMOs) that manufacture gene and cellular therapy agents mostly run small-scale facilities to produce clinical-stage substances, and the number of production facilities is also small. The vast majority of gene therapy products had remained in the clinical stage until the first mRNA therapy agent was approved last year, and unlike antibody therapy, there has not been any demand for large-scale production facilities. More recently, however, Company A, which produces pDNA, was acquired for USD 9.6 billion (approx. KRW 10 trillion), attesting to the surge in value of companies capable of producing gene and cellular therapy agents due to their rarity. 

REYON Pharmaceutical’s Chungju bio plant, located in Daesowon-myeon, Chungju-si, Chungcheongbuk-do Province, was built over the course of 4 years from September 2017 to June 2021, with a total budget of KRW 80 billion. 

It is a large-scale commercial production plant for gene and cellular therapy agents and is the one and only pharmaceutical plant capable of manufacturing not only drug substances but also drug products in the field of gene and cellular therapy agent in a one-stop production process. 

It will be able to mass-produce plasmid DNA (pDNA), a gene therapy agent that is produced based on microbial fermentation, and mRNA- and AAV-based vaccines and therapeutics as well as bacteriophages. 

The Chungju bio plant is equipped with 50L, 200L, and 500L multi-use incubators and 30L single-use incubators for drug substance production. It will also gain the capacity to simultaneously produce various drug substances through single-use incubators of various sizes such as 50 L and 500 L, the introduction of which is being coordinated in terms of the time frame. 

As for the drug products, it has the capacity to produce 48 million vials of liquid products and 9 million vials of freeze-dried products per year, and it is expected to be able to produce 720 million doses of mRNA vaccine per year. The Chungju bio plant is a modular plant with the utility systems already set up on an empty lot, which will make it possible to extend and expand the production line, and this will in turn further increase the product lineup and production capacity.  

Based on the production capacity, REYON Pharmaceutical plans to jointly develop and commercialize (secure exclusive production rights) with partners in the biopharmaceutical drug substance (DS) business, in addition to pursuing a drug product business as a contract development and manufacturing organization (CDMO). As such, it is currently discussing additional businesses with a number of domestic and foreign companies other than its current partners. 

REYON Pharmaceutical CEO Yoo Yong-hwan said, “In the biopharmaceutical market, the focus has solely been on startups specializing in drug substances, whereas companies with production facilities essential for the actual commercialization of drugs have been relatively undervalued. However, due to the recent issue of COVID-19 vaccine production, companies with biopharmaceutical production facilities are drawing attention. […] The biggest strength of the Chungju bio plant is that it is capable of mass-producing the stock solutions and drug products of plasmid DNA (pDNA) and mRNA and virus vector-based vaccines and therapeutics, based on the production technology and know-how related to ‘microbial fermentation’ acquired through in-house R&D and production of fermented drug substances. It will emerge as a global production hub in the gene and cellular therapy market.”

The construction completion ceremony for the Chungju bio plant has been postponed indefinitely in consideration of the COVID-19 situation. An official from the company said that it will be held together with the completion ceremony of REYON Pharmaceutical’s cGMP chemical plant in Chungju (scheduled to be completed in March 2022) that is currently under construction on the same site.