In January 2022, Cape Town-based biotechnology company Afrigen Biologics announced that it has successfully produced a lab-scale batch of a Covid-19 vaccine that is similar to that made by pharmaceutical company Moderna. The achievement is particularly impressive since the vaccine uses the still relatively new mRNA vaccine technology.
Without a technology transfer partner, Afrigen was forced to go it alone – albeit with significant support from international health agencies and technical experts from around the world. Vaccines given to humans as part of clinical trials or through health programmes can only be produced in facilities certified for complying with Good Manufacturing Practices – which Afrigen is currently working toward.
Using the RNA produced at Wits, the formulation, production of the vaccine drug substance, stability testing, and validation were all done at Afrigen. “We are now doing more batches and we will then start with some preclinical work,” she says. Using lab-scale batches, Afrigen can start undertaking preclinical research to gain insight into the quality and safety of their vaccine before moving to clinical trials with human subjects. At this stage, preclinical work includes conducting stability testing on the vaccine, validating production processes, and conducting preclinical safety evaluations.
Before Afrigen can apply for GMP certification from Sahpra, it must complete facility upgrades and installation of manufacturing equipment. “[Sahpra] needs to be at an ML3 status and specifically, vaccine GMP accredited before they can inspect our own facility,” says Terblanche. She adds that “Sahpra is well on track to reach their ML3 status before June, before we need them to audit us.”, “For a National Regulatory Authority to be able to rely on another regulator’s decision there needs to be an alignment in terms of the standards applied/work practices deployed, etc.
She says that Sahpra and the WHO are committed to fast-track the clinical development if the results warrant it. “Phase 2 will probably take about 12 months, and then we will go into Phase 3,” she says. She notes that both the WHO and local experts in clinical development will be involved in designing the trials.As a technology transfer Hub, Afrigen will be tasked with transferring technology to and training multiple international partners. The WHO has already announced 13 countries that will receive technology transfers from the Hub to enable their manufacture of Covid-19 mRNA vaccines.