WHO establishes global biomanufacturing training hub in Republic of Korea

The World Health Organization (WHO), the Republic of Korea and the WHO Academy yesterday announced the establishment of a global biomanufacturing training hub that will serve all Low- and Middle-Income Countries (LMICs) wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments. The move comes after the successful establishment of a global mRNA vaccine technology transfer hub in South Africa, WHO notified via a statement.

“One of the key barriers to successful technology transfer in LMICs is the lack of a skilled workforce and weak regulatory systems,” said Dr Tedros Adhanom Ghebreyesus, Director-General, WHO, in the statement.

The Government of the Republic of Korea has offered a large facility outside Seoul that is already carrying out biomanufacturing training for companies based in the country and will now expand its operations to accommodate trainees from other countries. The facility will provide technical and hands-on training on operational and Good Manufacturing Practice (GMP) requirements, and will complement specific trainings developed by the mRNA vaccine technology transfer hub in South Africa. The WHO Academy will work with the Korean Ministry of Health and Welfare to develop a comprehensive curriculum on general biomanufacturing, the statement added.

It also said that WHO is intensifying regulatory system strengthening through its Global Benchmarking Tool (GBT), an instrument that assesses regulatory authorities’ maturity level. The GBT will serve as the main parameter for WHO to include national regulators in the WHO-listed authorities list. Another aim is to build a network of regional centres of excellence that will act as advisers and guides for countries with weaker regulatory systems.

Five more countries will also receive support from the global mRNA hub in South Africa: Bangladesh, Indonesia, Pakistan, Serbia and Vietnam. These countries were vetted by a group of experts and proved that they had the capacity to absorb the technology and, with targetted training, move to the production stage relatively quickly, it further noted.

“Indonesia is one of the countries that continuously supports vaccine equity and equal access to COVID-19 vaccines for all countries, including through transfer of vaccine technology and know-how to developing countries. This transfer of technology will contribute to equal access to health counter measures, which will help us to recover together and recover stronger…………..”

Dr Nguyen Thanh Long, Minister of Health, Vietnam, also said in the statement, ”Our National Regulatory Authority (NRA) has also been recognised by WHO. We believe that in participating in this initiative, Vietnam will be able to produce the mRNA vaccine in a large scale, not only for domestic consumption, but also for other countries in the region and the world, contributing to reducing inequalities in access to vaccines.”

Argentina and Brazil were the first countries from the region of the Americas to receive mRNA technology from the global hub in South Africa, joining the initiative in September 2021. Companies from those countries are already receiving training from the technology transfer hub, the statement informed.

Numerous countries responded to the call for expressions of interest from the technology transfer hub in late 2021. WHO will provide support to all of the respondents, but is currently prioritising countries that do not have mRNA technology, but already have some biomanufacturing infrastructure and capacity. WHO will enter into discussions with other interested countries and other mRNA technology recipients will be announced in the coming months, concluded the statement.