Professor, Business Development; Managing Director of Afrigen Biologics, Northwestern University

Petro Terblanche is the managing director or Afrigen Biologics, and he is the host of the mRNA center-the subject of this article. However, she will not obtain any personal material benefits through this publication.

The World Health Organization and COVID Vaccine Global Access (COVAX) plan to announce in mid-2021 that they are working with a consortium to establish the first COVID messenger RNA (mRNA) vaccine technology transfer center on the African continent of South Africa. Natasha Joseph of Conversation Africa talked with Petro Terblanche, managing director of Afrigen and a professor at Northwestern University in South Africa, to discuss the significance of this work — and what it means to the African continent.

The technology transfer model aims to create a platform to promote the localized manufacturing of vaccines and stimulate vaccine innovation through cooperation with universities and scientific committees.

The pandemic stimulated and provided great impetus for the establishment of the first mRNA vaccine center in Africa. The use of hub-and-spoke models based on technology transfer practices is very common and mature, but it requires an important partnership between technology owners and recipients. A successful example is WHO's transfer of influenza vaccine technology to about ten developing countries during the 2007 pandemic. The insights from this case study are being applied to the mRNA Hub.

There are currently no vaccine technology centers in Africa, although there are six vaccine production facilities on the continent. One of them is the Pasteur Institute in Senegal; it produces yellow fever vaccines based on a technology transfer model.

The decision to establish a hub in South Africa was driven by COVAX. It realizes to some extent that providing the necessary vaccine supplies to Africa will not happen. This is partly because of the capabilities and priorities of established manufacturers; the African continent is completely dependent on the expansion of existing manufacturing capabilities in China, India, the United States and Europe.

Therefore, there is now a great impetus to manufacture vaccines in areas where vaccines are used. WHO will select some recipients of this technology from the mRNA center in South Africa, which has now been nominated as a global mRNA center for low- and middle-income countries. The center will transfer end-to-end vaccine production technology to recipients and train personnel from these entities to implement the technology. Recipient countries will produce commercial-scale vaccines and supply them to countries that need it most.

Read more: Messenger RNA: Its role in nature and vaccine manufacturing

Afrigen will become a technology transfer and training center: it shares technology and develops skills specifically around how to produce safe, effective and affordable mRNA vaccines.

We must establish a unit that fully complies with global good manufacturing processes, adheres to quality standards, patient and worker safety, and environmental responsibility. When we achieve these milestones, we will obtain a license from the South African Health Products Regulatory Authority, which will be internationally recognized by strict regulatory agencies.

At our factory in Cape Town, we will produce APIs and pharmaceutical products, which are finally formulated mRNA vaccines. The facility will be licensed to produce batches of clinical materials.

Afrigen will conduct phase 1 and phase 2 clinical trials, while transferring the end-to-end production process to Biovac; they will conduct phase 3 clinical trials and obtain full market authorization for commercial production and distribution to Africa. Biovac and Afrigen will have the capacity to produce more than 250 million doses per year-considering that Moderna and Pfizer BioNTech can produce 1.7 billion doses per year, this is still very small.

Other commercial production facilities in Africa will also receive Afrigen's vaccine technology.

We will also work closely with the South African University Consortium coordinated by the country's Medical Research Council to design and develop new and improved vaccines and manufacturing processes to achieve the successful commercialization of vaccine pipelines related to disease burden in Africa.

The development and production of any vaccine that meets safety and effectiveness goals and can be mass-produced in an affordable mode is complicated. It requires the integration of engineering and science with regulatory and quality systems at every step of the process. So this is a highly specialized job.

For mRNA vaccines, we need geneticists, bioprocess engineers, biochemists, analytical chemists, molecular biologists, pharmacists, and machine operators. Separating DNA into RNA strands is not easy; it uses various enzymes and processes, and scientists must ensure that RNA is stable and safe throughout the process.

The first step is to prepare all the necessary equipment and qualified personnel; then the vaccine is produced on a laboratory scale to ensure that we have the characteristics required for a safe and effective vaccine. After that, as part of training and process validation, we must scale up and produce vaccines under non-good manufacturing processes. Then there are good manufacturing process standards, all regulatory boxes are ticked.

By the end of September 2022, we should be ready for the first batch of good manufacturing processes. This is very ambitious, but we believe it is healthy pressure.

Read more: Vaccine production in South Africa: How to develop an industry in its infancy

We have very good support, which is very helpful. The WHO and the drug patent pool, together with the South African government, the African Union and the African Centers for Disease Control and Prevention, have made tremendous efforts and support. Funders have recognized that South African scientists are very capable-some of the space for global leaders in the field of vaccines.

People will come to us to learn. We maintain contact with research centers in Brazil, Argentina, Ukraine, Colombia, the Philippines and several other African countries. A group of people from the designated "hub spokes" will come to train with us. In such a laboratory, everyone is highly trained and professional, including cleaners; you operate in a completely sterile, temperature-controlled, and pollution-free environment.

Read more: No country is an island: collective measures against the COVID-19 vaccine are the only way out

We are exploring the "training the trainer" model. We may conduct some off-site training at the University of Cape Town and then transfer personnel to our facility to obtain their final qualification: to make the vaccine meet the standards of good manufacturing processes. They will bring this knowledge and technology back to their colleagues at home.

The consortium includes Afrigen Biologics and Vaccines (South Africa), Biovac (South Africa), a network of universities, and the African Center for Disease Control and Prevention, headquartered in Ethiopia.

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