Technovalia, Sypharma and BioNet are combining to create an Australian-based vaccine contract and product development and commercial-scale production of mRNA, DNA and recombinant vaccines.
The companies said their Memorandum of Understanding (MoU) formalises their mutual interaction and strengthens the existing relationship.
Genetis will operate as an independent vaccine hub offering contract development manufacturing services and product development expertise for mRNA, DNA and recombinant vaccines. I
t is the first of its kind and it will accelerate vaccine development and manufacturing through a comprehensive ecosystem in Victoria and Australia.
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.
They said Genetis will be operational in July 2022 for the 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.
Technovalia CEO Laurent Dapremont 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.”
BioNet CEO Dr Pham Hong Thai said, “Genetis is the first example of how deep collaborative 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.”
Sypharma CEO Ganesh Varnakulasingham added, “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.”