Watch the Video!
We are excited to share our strategic partnership with Afrigen and Thermo Fisher Scientific to produce the first African developed mRNA COVID-19 Vaccine. This fantastic partnership has involved great collaboration across diverse teams and showcases how they are truly making a difference across Africa.
Housed in a maze of airlocked sterile rooms in the mother city of Cape Town, a group of young South African scientists are working against the clock to produce the first locally designed and constructed coronavirus vaccine for Africa. The newly established mRNA vaccine hub is hosted by Afrigen; and is the first of its kind and scale in Africa capable of producing cGMP material for clinical trials. Their goal is to establish an end-to-end sustainable vaccine manufacturing capability independent of first world influence. This mRNA vaccine platform is established through a WHO (World Health Organisation) co-ordinated multi-partner initiative, which will later expand into various other under-researched African diseases such as TB and the dreaded Ebola virus.
At the lab level, the team has assembled the equipment needed for vaccines manufacturing. Deborah Shaw from Labotec spoke to Petro Terblanche, MD and Dr Caryn Fenner, Technical Director of Afrigen Biologics, to find out more about the technology transfer, production plans, significance and health benefits for the continent.
Afrigen forms part of the WHO-co-ordinated multi-partner initiative. Tell us more about the objectives and drive behind your newly established bio processing lab, and how this enterprise can possibly establish sustainable vaccine manufacturing capabilities and industry in Africa and other low to middle income countries (LMIC).
Afrigen Biologics is a biotechnology company centred on two main platforms. This includes a formulation platform (nano and microencapsulation) to improve delivery, stability and bioavailability of various actives. The second is an mRNA vaccine platform initially focusing on COVID-19 and then later expanding into other disease areas. The mRNA vaccine platform is being established through a WHO-co-ordinated multi-partner initiative of the COVAX workstream 3 to establish sustainable vaccine manufacturing capabilities and industry in Africa and LMIC. mRNA is the first vaccine platform to be established and will operate through a hub and spoke model. Afrigen, together with Biovac and the SAMRC form part of the SA consortium that will host this global mRNA hub, with Afrigen as the centre of excellence for technology transfer and training. The newly established mRNA vaccine facility in Afrigen will incorporate end-to-end manufacturing of mRNA Covid vaccine; from production of DNA plasmid template to mRNA drug substance manufacturing, formulation and fill/finish. The pilot scale mRNA vaccine facility will also be the first facility in Africa capable of producing material for clinical trials.
Why would you say this is significant and important for the African health sector?
Africa will forever be dependent on other countries for vaccines (and other medicines) if it does not have a sustainable vaccine manufacturing capability established locally. This would then be further supported by all the quality and regulatory aspects associated with vaccine manufacturing.
The first step is to produce a vaccine candidate that is safe, affordable and ready for use in humans against COVID–19, and then followed by other vaccines and medicines important for Africa, highlighting infectious diseases such as TB and Ebola virus.
An essential element will be the “tech transfer hub” that will train all partners using the hub and spoke model to establish centres across Africa and other LMICs with the capabilities and reach, making healthcare more affordable for the people on the continent.
What is the plan you are working towards in this race towards vaccine security?
Included in the mRNA hub is also a local innovation pipeline, which sees contributions from local universities and research entities, as well as some in other African countries that will contribute towards the full vaccine manufacturing value chain, including discovery and screening, preclinical testing and clinical trials. We are working towards our target of 18 months to put the first candidate into clinical trials. Our facility will be capable of producing a maximum of ten million vials per year of COVID-19 vaccines, and our local manufacturer Biovac can produce 30 million doses a year to distribute across Africa.
This mandate goes beyond COVID-19, including future pandemic preparedness, and targeting the high burden of disease and neglected diseases in Africa and other LMICs.
In assembling the equipment needed for this start-up, can you elaborate on your partnership with Thermo Fisher Scientific and Labotec and how it’s product (single-use biotech fermenter) has been used?
Afrigen strategically designed the vaccine facility to be multi-product (centred on a specific vaccine platform) and GMP accredited. The versatility that one obtains using single-use technology was perfectly suited for this design. Thus, a partnership was formed with Thermo Fisher Scientific, being one of the leading suppliers of single-use technology, and Labotec, the local supplier of these Thermo Fisher products in SA. The single-use fermenter will be used in the first step of mRNA vaccine manufacturing, which is the production of the DNA plasmid template in E. coli.
Thermo Fisher Scientific and Labotec have provided amazing technical support to the mRNA hub thus far. They have heavily invested time, money and expertise, rallying around us and providing support that will help ensure success of this particularly important work.