Pharmaceutical & Cosmetic Review May 2022

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PHARMA FOCUS: VACCINE MANUFACTURING & DISTRIBUTION

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

H

oused 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 bioprocessing lab and how will the enterprise establish sustainable vaccine manufacturing capabilities and industry in Africa and other lowto 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,

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MAY 2022 // WWW.PHARMACOS.CO.ZA

An African first, the Afrigen mRNA vaccine platform will operate through a hub and spoke model, with plans to later expand into addressing other diseases such as TB

"The pilot-scale mRNA vaccine facility will also be the first facility in Africa capable of producing material for clinical trials" 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


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