Afrigen wins GMP certification for Africa’s first end-to-end mRNA facility

Afrigen Biologics has secured SAHPRA Good Manufacturing Practice certification for its Cape Town mRNA facility, clearing the way for investigational biological products in Phase I and II trials. The milestone strengthens Africa’s push for local vaccine manufacturing, regional health security and long-term scientific capability.

Why it matters: - Afrigen’s certification gives Africa’s first end-to-end mRNA manufacturing facility regulatory approval to make investigational biological products for Phase I and II clinical trials. - The milestone strengthens local vaccine and biologics manufacturing capacity closer to where products are needed. - The facility adds to Africa’s ability to respond to future pandemics and improve health security. - The achievement also reflects a broader effort to build scientific, regulatory and manufacturing capability after COVID-19 exposed global inequities.

What happened: - Afrigen Biologics secured Good Manufacturing Practice certification from the South African Health Products Regulatory Authority for its mRNA facility in Cape Town. - The facility is the first end-to-end mRNA manufacturing site on the continent to reach this level. - SAHPRA’s certification confirms the facility meets internationally recognised manufacturing standards. - Afrigen now has authorization to manufacture investigational biological products for Phase I and II clinical trials.

The details: - Afrigen is part of the mRNA Technology Transfer Programme co-led by the World Health Organization and the Medicines Patent Pool. - The programme supports a network of partners across four continents. - Afrigen has moved from concept to a GMP-certified end-to-end facility in four years. - The site is designed to support research, development, technology transfer and clinical-trial-stage manufacturing. - Prof. Petro Terblanche, CEO of Afrigen Biologics, said the certification confirms the team is ready to support clinical trial material production and advance vaccine and biologics development. - WHO Director-General Dr Tedros Adhanom Ghebreyesus said Afrigen now serves as a quality-assured strategic platform for regional manufacturing, secure supply and pandemic preparedness. - Charles Gore, Executive Director of the Medicines Patent Pool, said the programme has moved from concept to regulated manufacturing capacity and a growing global network. - Bernd Lange, chair of the European Parliament’s Committee on International Trade, said the certification shows how EU-South African partnerships backed by European funding and technology can strengthen local vaccine manufacturing capacity. - The certification was supported through the EU’s Global Gateway flagship initiative, MAV+. - Dr Thapelo Motshudi, chair of SAHPRA’s board, said the certification shows African facilities can meet globally recognised standards and helps build confidence in the continent’s scientific and manufacturing capability.

Between the lines: - The certification is more than a regulatory win. It signals that Africa can move beyond reliance on imported vaccines and build part of the supply chain at home. - Afrigen’s progress also shows the role of blended public, multilateral and international support in scaling complex biomanufacturing capacity. - The comments from WHO, MPP, the EU and South African health leaders point to a shared focus on sustainability, not just launch-stage success. - Precise local manufacturing capability could improve access, but the longer-term test will be whether Afrigen can keep product pipelines full and operations financially durable.

What’s next: - Afrigen is preparing to transition toward a non-profit company structure in collaboration with the South African Medical Research Council. - The next phase will focus on long-term sustainability and public health impact. - Afrigen will continue working with partners across sectors on vaccine and biologics development, clinical development, manufacturing and access in South Africa, across Africa and globally. - WHO’s Tedros said the next phase of the mRNA Technology Transfer Programme must focus on sustainability, stronger product pipelines, partnerships and long-term capabilities. - Dr Aaron Motsoaledi, South Africa’s health minister, said the certification reflects the country’s commitment to strengthening local health manufacturing capacity. - Prof. Nicholas Crisp, South Africa’s director-general of health, said sustained investment in scientific, regulatory and manufacturing capability will be essential for future health emergencies. - Dr Ntobeko Ntusi, president and CEO of SAMRC, said the research council expects to work more closely with Afrigen to help secure long-term sustainability. - Precious Matsoso, co-chair of the Pandemic Fund, said Africa can sustainably manufacture products that save lives when it invests in African science. - Zacharia Kafuko of 1Day Sooner said the milestone matters because communities need faster and fairer access to vaccines and health technologies.