Hanmi Fine Chemical, a subsidiary of Hanmi Pharmaceutical Group, announced that it would expand its existing manufacturing capabilities to include ‘high-tech’ contract development and manufacturing organization (CDMO) services.
The company stated that this would involve engaging in CDMO projects that cover synthetic bio-pharmaceutical raw materials, specifically to target those used in mRNA vaccines, including lipid nanoparticles, nucleotides, capping materials, polyethylene glycol derivatives, and peptides.
In order to achieve this, the South Korean company will invest approximately ₩10bn (US$7.9m), which is supported through a ₩1.6bn (US$1.2m) government grant. Both Hanmi and the South Korean government highlighted the action as being made necessary by the demands of the COVID-19 pandemic.
According to the company, the CDMO area it is moving into is not a new one, as Hanmi Pharmaceutical’s own pipeline and portfolio of drugs contain various biologics, including BH2950 (fidasimtamab), a bispecific antibody in clinical trials that is targeting the treatment of solid tumors.
Hanmi stated that it is currently partnered with ten different domestic and foreign companies on preclinical and clinical CDMO projects, totaling a value of ₩10bn.
From API to mRNA
Hanmi Fine Chemicals previously specialized in the manufacture of active pharmaceutical ingredients (APIs) from its two facilities located in Gyeonggi-do, South Korea. From this location, the company produces sterile and oral cephalosporin APIs, as well as having the capacity to produce 20 different ‘general APIs,’ including raloxifene, pregabalin, and amlodipine camsylate.
The company previously invested into its CDMO services four years ago, which the CEO at the time had suggested would see this side of the company move ‘into full swing.’ Hanmi stated on its website that work is also currently underway at its Paltan site to expand capacity for its automated warehousing system.
The shift to working on CDMO services for mRNA raw materials is then a change of direction, but one that has been common across the industry following the outbreak of the pandemic. With the validation of mRNA technology, a number of CDMOs have invested in capabilities in the area to bolster services for both existing COVID-19-related demand and for potential further approvals.
Fellow South Korean CDMO, Samsung Biologics, announced last year that it would add mRNA vaccine drug substance production capability to be able to provide end-to-end mRNA vaccine manufacturing services.
The rapid build out of global capacity highlights the challenge of ensuring capacity meets demand, after the equally rapid development of an mRNA vaccine for COVID-19. The WHO has been working to support the build out of manufacturing capabilities in all regions of the world to ensure equitable access to both mRNA vaccines and the knowledge of the technology behind them.