Wednesday, January 26

Africa’s First mRNA Vaccine Technology Transfer Center Goes Live

The World Health Organization and the Covid Vaccines Global Access (Covax) initiative Announced By mid-2021, they were working with a consortium to establish the first Covid messenger RNA (mRNA) vaccine technology transfer center on the African continent, in South Africa. Natasha Joseph from The Conversation Africa spoke with Petro Terblanche, Afrigen’s managing director and professor at South Africa’s Northwest University, about what this work entails and what it will mean for the continent.

What is a technology transfer center?

The technology transfer model is designed to create a platform that facilitates localized vaccine manufacturing and stimulates vaccine innovation through partnerships with universities and scientific councils.

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The pandemic stimulated and gave an enormous impetus to the establishment of this first mRNA vaccine center based in Africa. the use of a cube and radius model based on technology transfer practices is fairly common and well established, but requires significant partnerships between technology owners and recipients. A successful example is the Transfer of flu vaccination technology from WHO to about ten developing countries during the 2007 pandemic. The insights from this case study are being applied to the mRNA Hub.

Africa currently does not have a vaccine technology center, although there are six vaccine production facilities on the continent. One of these is the Pasteur Institute in Senegal; it is based on a technology transfer model and produces the yellow fever vaccine.

The decision to establish a center in South Africa was driven by Covax. At some point in the pandemic he realized that the necessary vaccine supply to Africa was simply not going to happen. That’s partly due to the capacity and prioritization of established manufacturers; the continent is completely dependent on expanding existing manufacturing capacity in China, India, the United States, and Europe.

So now there is a significant push towards making vaccines in the region where they will be used. WHO will select some recipients of the mRNA Hub technology in South Africa, which has now been nominated as the global mRNA Hub for low- and middle-income countries. The center will transfer end-to-end vaccine production technology to recipients and train staff from these entities to implement the technology. Recipients will produce vaccines on a commercial scale and supply them to countries where they are most needed.

What is Afrigen’s role in this process?

Afrigen will be a center for technology transfer and training: it shares technology and develops skills specifically on how to produce a safe, effective and affordable mRNA vaccine.

We have to establish a unit that fully complies with the Good manufacturing processes, complying with quality standards, safety for patients and workers, environmental responsibility. When we achieve these milestones, we will obtain a license from the South African Medical Device Regulatory Authority, which will have the international endorsement of strict regulatory authorities.

TO Our Plant in Cape Town, we will manufacture the drug substance and the pharmaceutical product that is the final formulated mRNA vaccine. The facility will be licensed to produce batches of clinical material.

Afrigen will conduct phase 1 and phase 2 clinical trials while transferring end-to-end production processes to Biovac; will carry out the phase 3 clinical trial and obtain full market authorization for commercial production and distribution in Africa. Between Biovac and Afrigen there will be the capacity to produce more than 250 million doses per year; that’s small when you consider that Moderna and Pfizer-BioNTech can produce 1.7 billion doses a year.

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

We will also work closely with a consortium of South African universities, coordinated by the country’s Medical Research Council, to design and develop new and improved vaccines and manufacturing processes to enable the successful commercialization of a line of vaccines relevant to the burden of disease. in Africa.

Why are specialized skills required to produce vaccines with this technology?

The development and production of any vaccine that meets safety and efficacy goals, and can be scaled up in an affordable model, is complex. It requires the combination of engineering and science with regulatory and quality systems at every step of the process. So it is a highly specialized job.

For mRNA vaccines, we need geneticists, bioprocess engineers, biochemists, analytical chemists, molecular biologists, pharmacists, and mechanical operators. It is not easy to separate DNA into strands of RNA; uses all kinds of enzymes and processes, and scientists must ensure that RNA is stable and safe for use.

What are your timelines?

The first step is to get all the necessary equipment and qualified people in your place; then, to produce the vaccine on a laboratory scale to ensure that we have the necessary properties for a safe and effective vaccine. After that, we have to scale up and produce vaccines under manufacturing processes that are not good, as part of the training and validation of the process. Then, to the standards of Good Manufacturing Processes, with all the regulatory boxes checked.

By the end of September 2022, we should have the first batches of good manufacturing processes ready. It is very ambitious, but we think it is a healthy pressure.

It helps that we are well supported. The WHO and the drug patent group, along with the South African government, the African Union and the African CDC, have put in enormous effort and support, and funders have recognized that South African scientists are very capable: some of the world leaders in the vaccine. space.

Where does the ‘transfer’ part of your work come in?

People will come to us to learn. We are in contact with research centers in Brazil, Argentina, Ukraine, Colombia, the Philippines and several other African countries. Groups of people from the designated “hub rays” will come and train with us. In a lab like this, everyone is highly trained and specialized, up to and including the cleaners; you are operating in an environment that is totally sterile and temperature controlled and must be free from contamination.

We are exploring a “train the trainers” model. We will likely do some off-site training at the University of Cape Town, then we will transfer people to our facility to get their final grade – making the vaccine meet Good Manufacturing Processes standards. They will bring that knowledge and technology to their colleagues at home.

The consortium is comprised of Afrigen Biologics and Vaccines (South Africa), Biovac (South Africa), a network of universities, as well as the African Centers for Disease Control and Prevention, based in Ethiopia.The conversation

Petro Terblanche, Professor, business development; Managing Director, Afrigen Biologics, Northwestern University

This article is republished from The conversation under a Creative Commons license. Read the Original article.

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