End-to-end Australian capability
Establishment of the first end-to-end Australian capability for product development and commercial scale production of mRNA, DNA and
recombinant vaccines.
By bringing together the technology, product development, GMP manufacturing, clinical and
regulatory expertise of key consortium partners
Technovalia, Sypharma and BioNet, Genetis will provide a unique Australian-based vaccine contract and product development manufacturing hub for Australian and offshore research organisations seeking access to quality capability and TGA approved products.
The founding partners have been sharing common interest and commitment in the fight against the COVID-19 pandemic through the rapid development, production and/or evaluation of several COVID vaccines. BioNet has established a strong DNA and mRNA manufacturing platform and produced
vaccines candidates in clinical development stage. Technovalia has initiated the first needle-free DNA COVID vaccine trial in Australia, and Sypharma has been involved in the fill-finish and manufacture of several COVID vaccine candidates.
The agreement, in the form of a Memorandum
of Understanding (MoU), formalises the mutual
interaction and strengthens the existing relationship between BioNet, Sypharma and Technovalia at the strategic and operational levels. Genetis will operate as an independent Vaccine Hub offering Contract Development Manufacturing Services and
Genetis operational by mid year, 2022
Genetis will be operational in July 2022 for formulation, end of line packaging and fill-finish.
Drug Substance and Drug Product GMP
manufacturing capability is scheduled for 2023 and large-scale commercial capability for 2024.
Mr. Laurent Dapremont, Chief Executive Officer of Technovalia said:
“We are very pleased to see the crystallisation of
a project which started 18 months ago with the
assembly of a unique consortium of partners
bringing the key assets, expertise and commitment to establish a comprehensive solution to the development and production of innovative vaccines in Australia. We are convinced that Genetis will contribute significantly to strengthen Australian’ sovereignty for essential medicines and add significant value to the rich Australian research ecosystem.”
Dr. Pham Hong Thai, Chief Executive Officer of
BioNet, said:
“Genetis is the first example of how deep collaborativ efforts between local and international partners can create value. By leveraging existing Sypharma’s assets, TGA-certified facilities and CMO expertise, we can rapidly transfer BioNet’s nucleic acid vaccine
manufacturing platform, enable and scale up both fill and finish, and drug substance manufacturing capacity in Australia. Combined to BioNet’s and Technovalia’s expertise in product development, Genetis will offer a unique value to Australian researchers and partners”.
Mr. Ganesh Varnakulasingham, Chief Executive
Officer of Sypharma, said:
“We are very excited by the launch of Genetis.
Based on its expertise in recombinant vaccine
development and manufacturing, BioNet has
developed and optimised in a record time a nucleic acid manufacturing platform (mRNA and DNA) which can significantly help in the fight against the current pandemic, and against future threats. The Genetis business model allows to rapidly deploy this technology in Australia offering a unique inclusive value proposition to all stakeholders.”
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Collaboration & Potential
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