Africa’s first end-to-end mRNA facility secures SAHPRA approval

Afrigen Biologics has achieved a historic milestone. Its Cape Town-based mRNA facility has received Good Manufacturing Practice (GMP) certification from the South African Health Products Regulatory Authority (SAHPRA). This establishes Afrigen as the first end-to-end mRNA GMP-certified facility in Africa, authorised to manufacture investigational biological products for Phase I and II clinical trials.

Strengthening Africa’s vaccine manufacturing capacity

The GMP certification marks a significant step forward in bolstering Africa’s vaccine and biologics manufacturing capabilities. It enhances regional supply security, pandemic preparedness, and health sovereignty, ensuring Africa can play a pivotal role in global health initiatives.

Afrigen’s facility is a core partner in the WHO-MPP mRNA Technology Transfer Programme, which supports a global network of partners in advancing mRNA technology and manufacturing.

Rapid progress and global partnerships

In just four years, Afrigen has transformed its facility from concept to a GMP-certified, end-to-end R&D and clinical manufacturing hub. This achievement was made possible through partnerships with the WHO, Medicines Patent Pool (MPP), EU Global Gateway/MAV+, South African government bodies, and civil society organisations.

Regulatory endorsement and future plans

SAHPRA’s rigorous certification process underscores the confidence in African manufacturing standards. Afrigen plans to transition toward a non-profit structure in collaboration with the South African Medical Research Council (SAMRC). The organisation will focus on sustainability, strengthening product pipelines, and supporting vaccine and biologics development across Africa and globally.

Prof. Petro Terblanche, CEO of Afrigen, stated, “This GMP certification is a testament to Africa’s ability to lead in mRNA technology and vaccine manufacturing.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, added: “Afrigen’s achievement is a critical step in ensuring equitable access to vaccines and advancing health sovereignty in Africa.”