TOKYO -- Takara Bio will mass produce mRNA vaccines from next year on a contract basis, Nikkei has learned, becoming one of the first Japanese companies to build key manufacturing facilities that will help cut the nation's reliance on imports.
Takara Bio will repurpose equipment at its mainstay plant in Kusatsu, a city in Shiga Prefecture, with production starting as soon as January.
The operation will make plasmid DNA as well as mRNA vaccine starting material. Takara Bio expects to tap technology from clients to convert the starting material into the final product.
Japan's lack of manufacturing capacity for shots devised with pioneering technology led to delays in its vaccine rollout as it waited for Moderna and Pfizer coronavirus vaccines to arrive. Takara Bio's venture is expected to lower the risk of supply bottlenecks not just for the current coronavirus pandemic but for future pandemics as well.
The output volume will differ depending on the vaccine. Takara Bio plans to have enough capacity to make the equivalent of 12 million Pfizer vaccine doses a year.
No new investments are planned for now, though the company will consider production line expansion if demand expands.
Takara Bio previously won a contract to produce DNA vaccines, which are similar to the mRNA type, for domestic biopharmaceutical company Anges, which is developing a coronavirus vaccine.
Vaccines using mRNA technology were first put into practice to combat the coronavirus outbreak. Such vaccines can be developed quickly using the genetic information of the target virus.
Conventional vaccines usually take years to develop, but both Pfizer and Moderna brought their shots into general use in less than a year. To hasten mass production, Moderna outsourced production to Switzerland's Lonza Group and other pharmaceutical companies.
"If domestic production becomes feasible, the risk of dependence on offshore supply will diminish, and we'll be better prepared for a pandemic," said Kouhei Tsumoto, a professor at the University of Tokyo who is an expert in biomedicine.
It is common practice in the pharmaceutical industry to produce vaccines on contract locally in the recipient market. The recent rise of biopharmaceuticals has elevated the technological level in the contract manufacturing sector.
Since mRNA vaccines entered into practical application last year, investments have poured into contract manufacturing facilities around the world. In South Korea, Samsung Biologics will launch its own mRNA vaccine production business in 2022.
Japan's AGC will contract produce mRNA starting material as early as 2023 at a German factory operated by subsidiary AGC Biologics. Elsewhere in Japan, Daiichi Sankyo is developing its own mRNA vaccine and will establish a mass production infrastructure next year. Axcelead is preparing to mass produce mRNA vaccines in 2025.