'Failure was never an option,” said Afrigen Biologics CEO Professor Petro Terblanche last week as the company – which developed an mRNA vaccine from scratch during Covid-19 – became the first African facility to be certified to manufacture investigational biological products for phase I and 2 clinical trials, writes Kerry Cullinan for Health Policy Watch.
The recognition means it now meets internationally recognised pharmaceutical manufacturing standards, and Terblanche paid tribute to her team, the WHO, Medicines Patent Pool (MPP) and several key donors as the facility celebrated receiving its Good Manufacturing Practice (GMP) certification from the South African Health Products Regulatory Authority (SAHPRA).
In June 2021, Afrigen was selected as the “mRNA hub” by the WHO and MPP – along with BioVac and the South African Medicines Control Council – and, she said, the company then had the “enormous task of developing 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”.
Afrigen’s 15 partners, including Bangladesh, Brazil, Egypt, India, Nigeria, Ukraine, Serbia and Vietnam, are using the knowledge acquired from the hub to develop mRNA products to tackle various challenges, from cancer to dengue to foot-and-mouth disease in animals.
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”.
“Six years ago, before Covid, the idea that in Africa we would have this kind of progress and a cutting-edge technology would have been unthinkable,” he said, adding that the next phase of the mRNA Technology Transfer Programme was to ensure it is “really sustainable, because there is no point having the capacity if you then walk away and leave it to stagnate”.
This means that Afrigen and its partners will need to make – and sell – high quality products to governments and companies.
As previously reported by Health Policy Watch, the key challenge facing all mRNA hub partners is to ensure that governments procure their vaccines and medicines – although the new start-ups’ products are likely to be more expensive than the giant pharma firms that have been in the business for years and are already supplying large global markets.
Dr Claudia Nannei, the WHO’s team lead in product development and manufacturing, said the GMP certification “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”.
See more from MedicalBrief archives:
Major boost for Afrigen with $6.2m grant for mRNA jab
Governments’ support urged for purchase of regional mRNA jabs
Africa must rise to reap benefits of vaccine research – virologist