Press Release

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Quantoom Biosciences Prepares for the Implementation of the Ntensify™ Midi System by Afrigen Biologics’ in their GMP Facility, Paving the Way for African-Owned mRNA Vaccine Production

September 18, 2023

The Ntensify™ Midi System Sets the Stage for Equitable Vaccine Access

 

Quantoom Biosciences S.A. (“Quantoom”), a Univercells company, proudly announces the implementation of its first Ntensify™ Midi system for mRNA vaccine production in the GMP facility of Afrigen Biologics (“Afrigen”) in Cape Town, South Africa. This relies on Quantoom’s efforts to validate the system covering the construct-agnostic mRNA synthesis and purification process as well as the piece of equipment automating all unit operations, delivering mRNA Drug Substance in yield and quality, according to pre-defined critical quality attributes. This achievement marks a significant advancement in the field of mRNA manufacturing and sets the stage for the development of African-owned mRNA vaccines, supporting the advancement of Afrigen’s mRNA vaccine pipeline towards clinical development.

The Ntensify™ Midi system, which was successfully delivered and installed a few months ago at Afrigen represents a game-changing technology for RNA manufacture. This milestone was notably celebrated during a general meeting of the mRNA Technology Transfer Programme in Cape Town, with esteemed attendees including Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, Dr. Matshidiso Moeti, WHO Regional Director for Africa, Charles Gore, Executive Director of MPP, and honorable ministers. Implementation of the Ntensify™ Midi system in the GMP vaccine manufacturing suite includes the qualification and evaluation of the technology in the hands of the first users, which will further support the claims of the technology.

As part of the mRNA Technology Transfer Programme initiated by the World Health Organisation (WHO), Quantoom partnered up with Afrigen to support the development of a second-generation mRNA vaccines. This collaboration aligns with the broader goal of achieving equitable vaccine access for low- and middle-income countries (LMICs). This new milestone for the Ntensify™ Midi system is a testament to the commitment of both Quantoom and Afrigen to bring innovative solutions to global health challenges.

The Ntensify™ Midi system, which was developed with funding from the Bill & Melinda Gates Foundation, introduces a revolutionary approach to mRNA synthesis and purification. With its construct-agnostic process and automated sequential-staggered production capabilities, it enables a cost-effective solution for gram-scale batch quantities of mRNA Drug Substance. This GMP-compliant instrument is poised to play a pivotal role in mRNA-based vaccine development and manufacturing.

José Castillo, CEO of Quantoom Biosciences, commented: "Less than two years ago, we embarked on a mission to revolutionize mRNA production driven by a pandemic readiness goal, while ensuring a sustainable production model during endemic times. The use of NtensifyTM for the production of clinical batches in the context of the development of African-owned mRNA vaccines showcases our dedication to pushing the boundaries of what is possible, especially when it comes to global health."

Prof. Petro Terblanche, CEO of Afrigen Biologics, also shared her enthusiasm: "Our partnership with Quantoom is bearing fruit and we are delighted to share that the Afrigen technical and production teams have recently visited Quantoom for technology transfer training. The successful installation of the NtensifyTM system in Cape Town in April was a crucial step. Today, we are thrilled to adopt this game-changing technology for the production of clinical batches as part of our pipeline of product’s development plans, and we look forward to leveraging it to ensure equitable access to vaccines in all parts of the World."

Quantoom Biosciences remains committed to driving innovation in the field of biotechnology and contributing to global health initiatives. The successful validation of the Ntensify™ Midi system represents a milestone that brings us closer to the realization of an African-owned mRNA vaccine and a more equitable vaccine distribution in general.

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