06.11.2023

Making mRNA vaccine production in Africa a reality

As part of an mRNA technology transfer program launched by the World Health Organization (WHO), the biotechnology companies Quantoom BioSciences (part of Univercells) and Afrigen Biologics have joined forces to create a second generation of mRNA vaccines. This collaboration is part of a wider effort to ensure equitable access to vaccines for Low and Middle Income Countries (LMICs). This latest milestone for the Ntensify™ Midi system testifies to Quantoom and Afrigen's commitment to providing innovative solutions to global health challenges.

A first implementation in Cape Town

The first Ntensify^TM Midi system for mRNA manufacturing was successfully installed at Afrigen Biologics in Cape Town, South Africa.

This RNA production system is part of a bigger platform named Nfinity^TM which actually combines three production technologies: one for DNA production, one for RNA production and one for LNP formulation. Together they enable mRNA production from DNA sequence up to formulated mRNA (drug product), ready for clinical trials.

According to the company, the Ntensify^TM Midi system, which was developed with funding from the Bill & Melinda Gates Foundation, introduces a revolutionary approach to mRNA synthesis and purification.

The construct-agnostic platform, used with complementary reagent pre-mixes, allows for the automated continuous production of gram-scale quantities (from 1 to 5g per day) of mRNA drug substance in a cost-effective manner.

"We are excited about the potential of this game-changing technology for continuous mRNA manufacturing, and we look forward to leveraging it to create a sustainable and reliable supply of vaccines in Africa", said Petro Terblanche, CEO of Afrigen.

"The Ntensify Midi system brings radical innovation to mRNA production, and its successful installation in Cape Town is a testament to Quantoom's commitment to providing innovative solutions for global health", said José Castillo, CEO of Quantoom Biosciences.

Producing the very first African-owned mRNA COVID-19 vaccine

The COVID-19 pandemic demonstrated the power of RNA vaccines. Quantoom Biosciences started the project with the objective to reinvent the way mRNA was produced, by breaking down barriers from discovery to development, up to commercial production.

It took almost two years for the Belgian biotech company to redesign the production process, its implementation into reagent pre-mixes and plastic disposables, and the automation of that process through low footprint robotized systems for R&D and GMP uses.These efforts resulted in the development of a GMP-grade RNA production system that is suitable for the manufacturing of mRNA, but also saRNA, at a scale for clinical phases I and II.

This achievement marks a significant advance in mRNA manufacturing and paves the way for the development of African-owned mRNA vaccines, starting with vaccines against COVID-19. It will also support the advancement of Afrigen's mRNA vaccine pipeline towards clinical development.

"We are delighted to partner with Quantoom for the development of the first African-owned mRNA COVID-19 vaccine. The successful installation of the Ntensify system in Cape Town is a crucial step towards achieving this goal and ensuring equitable access to vaccines for LMICs", declared the CEO of Afrigen Biologics.

Ensuring a sustainable production model during both pandemic and endemic periods

José Castillo, CEO of Quantoom Biosciences, commented: "Less than two years ago, we embarked on a mission to revolutionize mRNA production with a view to pandemic preparedness, while ensuring a sustainable production model during endemic periods. The use of NtensifyTM for clinical batch production in the development of mRNA vaccines of African origin demonstrates our commitment to pushing back the boundaries of what is possible, particularly in the field of global health."

Quantoom Biosciences was a finalist at the latest edition of the essenscia Innovation Award, the leading prize for industrial innovation in Belgium. Other finalists were Agfa-Gevaert (award winner for their Zirfon membrane technology for hydrogen production), GSK, Power to Methanol (a consortium uniting Advario, ENGIE, Fluxys, Indaver, INEOS Inovyn, Port of Antwerp-Bruges and PMV), and Soudal.

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