EuBiologics said its second plant (V Plant) in Chuncheon has received good manufacturing practice (GMP) certification from the Ministry of Food and Drug Safety (MFDS) for the production of Euvichol-S, its oral cholera vaccine. This certification also includes the approval of the plant as an additional manufacturing site for the final product.

To expand the supply of cholera vaccines, EuBiologics has been expanding its bulk and finished product manufacturing facilities at the second plant over the past three years, backed by approximately $10 million in funding from the Bill & Melinda Gates Foundation.

As a result, in April 2024, the Euvichol-S vaccine received prequalification (PQ) approval from the World Health Organization (WHO). In May that year, the company won approval of the bulk production facility at the second plant.

With the latest GMP certification for the final product manufacturing facility, the company expects to secure WHO PQ approval for this facility in the second quarter, enabling the full operation of both bulk and final product production at the first and second plants.

Once fully operational, the company's annual cholera vaccine production capacity is projected to reach 80 million to 90 million doses.

The newly established final product manufacturing facility at the second plant features state-of-the-art equipment upgrades, improving filling capacity by 150 percent compared to the first plant.

Additionally, it reduces batch manufacturing time by over seven hours, significantly enhancing efficiency. The ability to produce the same vaccine at both plants minimizes manufacturing risks, ensuring stable and increased cholera vaccine production.

"The MFDS approval for the second plant's final product manufacturing facility marks a crucial milestone leading to WHO PQ approval,” EuBiologics Production 2 Division Head Park Young-shin said. “Once the WHO PQ amendment approval is obtained in the second quarter, the cholera vaccine supply will more than double, ensuring a stable and reliable supply.”

This will also help address UNICEF’s cholera vaccine supply concerns, Park added.

EuBiologics is actively expanding into the global private market in addition to its public market dominance for cholera vaccines.