Hanmi Pharmaceutical on Monday said it has enough production capacity to contract manufacture COVID-19 vaccines.

“Hanmi Pharmaceutical has various capabilities and facilities where we can produce nucleic acid vaccines as a contract manufacturing/development organization,” said CEO Kwon Se-chang.

“We are open to potential collaboration with various companies to contribute to ending the global pandemic.”

Among others, the executive pointed to its newly built Bio Plant in Pyeongtaek, Gyeonggi Province, as a contract development and manufacturing facility.

Hanmi’s Bio Plant possesses a good manufacturing practices facility where bulk drug substances of messenger RNA and plasmid DNA vaccines can be produced. Plasmid DNA, or pDNA, is the precursor to mRNA synthesis, which is the key substance of nucleic acid vaccines.

Hanmi says its Bio Plant can produce approximately 10,000 liters of culture media per batch through a three-day E. coli culture process. This amount can produce millions of doses of nucleic acid vaccines. Per year, the Bio Plant can supply over 100 batches of nucleic acid vaccine drug substances, sufficient to vaccinate hundreds of millions of people.

Hanmi can supply raw materials through its subsidiary Hanmi Fine Chemical, which has the capability to produce nucleotides, active pharmaceutical ingredients, intermediates, peptides and lipids -- lipids being the raw materials for mRNA vaccine formulation.

According to Hanmi, its Bio Plant has two production buildings over an area of some 51,500 square meters. At the plant, Hanmi has over 500 employees for manufacturing, quality control and quality assessment, engineering, process/analytical development and regulatory affairs. 

The second building completed construction in 2019 as a six-story building with a total floor area of some 28,200 square meters. This second building is equipped with a state-of-the-art facility that can produce up to 100 batches per year of 20,000 liters of microorganism culture and purification, Hanmi said.

The plant also has a syringe filling facility to produce finished injectable products, possessing optimal conditions as a global manufacturing base for biological drugs.

Not only promoting itself as a potential vaccine factory, the company recently released an antiviral nasal spray called Hanmi Cold-Mask, the main ingredient of which is the lambda-carrageenan extract that can prevent respiratory viral infection. Hanmi plans to follow that up with a dual diagnostic kit for COVID-19 and influenza in February.

Hanmi announced “endless challenges and new commitments for the pharmaceutical industry” as its management slogan for 2021.

The company is still in the process of identifying preclinical stage candidates for COVID-19 treatments, using new chemical entities and thymosin hormones of PIKfyve inhibitors, which has risen as a potential cancer therapy in recent medical research.

Other than COVID-19 endeavors, Hanmi has a pipeline of 28 new drugs, including eight drugs for metabolic diseases, 12 anti-cancer drugs, five drugs for rare diseases and three drugs for other diseases. The company has more than 580 staff who specialize in research and development.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)