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Africa welcomes its first locally-developed and produced mRNA Covid vaccine
Labotec is excited to share its strategic partnership with Afrigen and Thermo Fisher Scientific to produce the first African-developed mRNA Covid-19 vaccine. This fantastic partnership is the result of great collaboration across diverse teams, and is truly making a difference throughout Africa. By Deborah Shaw of Labotec
Housed in a maze of airlocked sterile rooms in the City of Cape Town, a group of young South African scientists are working against the clock to produce the first locally-designed coronavirus vaccine for Africa.
Formally established in July 2021, the mRNA vaccine Technology Transfer Hub is hosted by Afrigen Biologics and Vaccines (Afrigen). It is the first of its kind and scale in Africa which is capable of producing cGMP material for clinical trials. The goal of the hub is to establish an end-to-end sustainable vaccine manufacturing capability independent of first-world influence. This mRNA vaccine platform was established through a World Health Organization (WHO) coordinated multi-partner initiative, which will later expand into various other underresearched African diseases such as TB and the dreaded Ebola virus.
At the lab level, the team has assembled the equipment needed for vaccine manufacturing. Petro Terblanche, MD of Afrigen, and its technical director, Dr Caryn Fenner, gave me an overview of the technology transfer. They discussed the production plans, significance of the project and the health benefits for the continent.
Creating sustainable vaccine manufacturing in Africa
Afrigen forms part of a WHO-coordinated multi-partner initiative. What are the objectives and drive behind this newly established bio-processing lab and how will the enterprise establish sustainable vaccine manufacturing capabilities and industry in Africa and other low- to middle-income countries (LMIC)?
As a biotechnology company, Afrigen is centred on two main platforms. One is 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-coordinated multi-partner initiative of the COVAX workstream 3 to institute sustainable vaccine manufacturing capabilities and industry in Africa and LMIC. mRNA is the first vaccine platform to be set up which will operate through a hub and spoke model.
Afrigen, Biovac and the South African Medical Research Council form part of the South African 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 within Afrigen will incorporate end-to-end manufacturing of mRNA Covid vaccines, from the production of DNA plasmid templates 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.
A significant milestone for Africa’s health sector
Africa will forever be dependent on other countries for vaccines (and other medicines) if it does not establish its own sustainable vaccine manufacturing capabilities. This would then be supported by 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, followed by other vaccines and medicines of importance to Africa’s healthcare needs. Those for infectious diseases such as TB and Ebola virus are highlighted in this regard.
An essential element in this project is the tech transfer hub, which will train all partners using the hub and spoke model to establish centres across Africa and other LMICs with the capabilities and reach. Ultimately, the goal is to make healthcare more affordable for and accessible to people on the African continent.
Did you know?
Afrigen’s laboratories are based in Montague Gardens in Cape Town. The product development and analytical laboratories are furnished with specialised equipment for formulation, downstream processing and analytical capabilities. The location is conveniently within close proximity to the Biomedical Research and Innovation Platform of the South African Medical Research Council.
Plan to establish vaccine security
Included in the mRNA hub is also a local innovation pipeline, which sees contributions from universities and research entities based in South Africa. These contributions will be supported by entities from other African countries who will also play a role in the full vaccine manufacturing value chain, including discovery and screening, preclinical testing and clinical trials.
The teams are working towards their target of 18 months to put the first candidate into clinical trials. The facility will be capable of producing a maximum of 10 million vials per year of Covid-19 vaccines, and the 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.
Single-use biotech fermenter partnership
In assembling the equipment needed for this start-up, Afrigen established a partnership with Thermo Fisher Scientific and Labotec to make use of a single-use biotech fermenter.
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 distributor of these Thermo Fisher products in South Africa. 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.
So far, Thermo Fisher Scientific and Labotec have provided amazing technical support to the mRNA hub. Both companies have heavily invested their time, money and expertise, rallying around Afrigen and providing support that will help ensure the success of this particularly important work. •
Successful installation by Labotec of the Thermo Scientific single-use fermenter at Afrigen Biologics. The fermenter will be used in the first step of mRNA vaccine manufacturing, producing the DNA plasmid template in E. coli
