South Africa's Afrigen Biologics Becomes First African Facility to Receive GMP Certification for mRNA Manufacturing
核心洞察
Afrigen Biologics (搜索) in Cape Town has become the first African facility certified to manufacture investigational biological products for Phase I and II clinical trials, receiving Good Manufacturing Practice certification from South African regulators.
The facility was selected as the WHO mRNA hub in 2021 and has successfully transferred technology to 15 partners across four continents representing four billion people in low-middle-income countries.
Partners are developing mRNA products to address diverse health challenges including cancer (搜索), dengue (搜索), and foot-and-mouth disease (搜索), marking a significant milestone for Africa's health sovereignty and pandemic preparedness capabilities.
Afrigen Biologics (搜索), the South African facility that developed an mRNA vaccine from scratch during COVID-19 (搜索), has achieved a historic milestone by becoming the first African facility certified to manufacture investigational biological products for Phase I and II clinical trials. The Cape Town-based facility received its Good Manufacturing Practice (GMP) certification from the South African Health Products Regulatory Authority (搜索) (SAHPRA) on Wednesday, marking a significant advancement in Africa's pharmaceutical manufacturing capabilities.
The GMP certification means that Afrigen now meets internationally recognized pharmaceutical manufacturing standards, positioning the facility as a quality-assured strategic platform for regional manufacturing. "Failure was never an option," said Afrigen CEO Professor Petro Terblanche, while paying tribute to her team, the World Health Organization (WHO), Medicines Patent Pool (搜索) (MPP) and several key donors.
From Concept to Global Network
Almost four years ago, on 21 June 2021, Afrigen was selected as the "mRNA hub" by the WHO and MPP, along with BioVac (搜索) and the South African Medicines Control Council. The facility faced the "enormous task to develop an mRNA platform, to industrialise it and to transfer technology to 15 partners on four continents in low-middle-income countries representing four billion people," according to Terblanche.
The achievement represents a remarkable transformation from concept to regulated manufacturing capacity. MPP head Charles Gore described the developments over the past four years as "mindboggling," as the programme moved "from concept to regulated manufacturing capacity and a growing global network."
"The idea that, in Africa, we would have this kind of progress and a cutting-edge technology six years ago, before COVID-19 (搜索), would have been unthinkable," said Gore. "What has developed here [has been] transferred out across LMICs to make the world a better and safer place."
Expanding Global Impact
Afrigen's 15 partners, including facilities in Bangladesh, Brazil, Egypt, India, Nigeria, Ukraine, Serbia and Vietnam, are using the knowledge acquired from the hub to develop mRNA products addressing a wide range of health challenges. These applications extend beyond traditional vaccines to include treatments for cancer (搜索), dengue (搜索), and even foot-and-mouth disease (搜索) in animals.
"We are ready to support clinical trial material production, advance technology transfer and contribute meaningfully to vaccine and biologics development and manufacturing," Terblanche stated.
Sustainability Challenges Ahead
Despite the celebration, leaders emphasized that the next critical phase involves ensuring long-term sustainability. Gore highlighted that the next phase of the mRNA Technology Transfer Programme must ensure it is "really sustainable, because there is no point having the capacity if you then walk away and leave it to stagnate."
This sustainability challenge requires Afrigen and its partners to manufacture and sell high-quality products to governments and companies. However, a key obstacle facing all mRNA hub partners is ensuring government procurement of their vaccines and medicines, particularly as new start-ups' products are likely to be more expensive than established pharmaceutical giants that have been supplying large global markets for years.
Global Health Milestone
WHO Director General Dr Tedros Adhanom Ghebreyesus described the GMP certification as "an important milestone not only for South Africa and the African continent, but also for global health" in a video message to the gathering. "Afrigen now serves as a quality-assured strategic platform for regional manufacturing, contributing to secure supply, pandemic preparedness and Africa's health sovereignty."
Tedros stressed that the next phase of the programme "must focus on sustainability, strengthening product pipelines, partnerships and long-term capabilities." He also acknowledged the support from the governments of South Africa, Belgium, Canada, France, Germany, and the European Commission.
Dr Claudia Nannei, WHO's team lead in product development and manufacturing, emphasized that the GMP certification represents more than a technical achievement. "It demonstrates that advanced quality assurance mRNA manufacturing capacity can be developed from scratch on the African continent, as long as it's grounded on scientific excellence," she said.