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Charles River and Ziphius Vaccines to Manufacture saRNA-based Vaccine

Program aimed to deliver early-stage clinical supply of plasmid DNA for drug substance manufacturing.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Charles River Laboratories and Ziphius Vaccines, a biopharmaceutical company developing self-amplifying RNA (saRNA) based medicinal products for vaccine and therapeutic applications, entered an agreement to manufacture starting materials critical to clinical-stage research.

Ziphius Vaccines is developing a proprietary self-amplifying mRNA technology platform combined with innovative lipid formulations for delivery. saRNA or replicon RNA has the advantage of having self-replicating features, as the saRNA molecule encodes a viral RNA replicase in addition to the sequence of the protein(s) of interest. This mechanism leads to enhanced and prolonged protein expression levels at lower doses compared to conventional mRNA.

Plasmid DNA Manufacturing Services

Plasmid DNA is a critical starting material in the development of many advanced therapies. This collaboration will leverage Charles River’s expertise in GMP and High Quality (HQ) plasmid DNA production. Utilizing Charles River’s custom HQ plasmid offering will benefit Ziphius Vaccines with accelerated timelines without compromising on quality. Charles River, with the acquisitions of Cognate BioServices, Cobra Biologics and Vigene Biosciences in 2021, has expanded its cell and gene therapy portfolio to include CDMO capabilities spanning viral vector, plasmid DNA and cellular therapy production for clinical through to commercial supply.

“We are proud to work with Ziphius Vaccines in their early-stage program,” said Kerstin Dolph, senior vice president, global biologics, Charles River. “The advancement of saRNA technologies is an exciting avenue for the development of vaccines and therapeutic programs, and we’re looking forward to a successful partnership.”

Chris Cardon, CEO, Ziphius Vaccines, said, “This collaboration with Charles River is an important milestone towards clinical testing and further validation of our vaccine candidates. Charles River’s expertise in plasmid manufacturing made them the best partner for this stage of our saRNA manufacturing program. As we continue the development of our saRNA and carrier technology platform, we’re excited by the potential their scale and efficiency offers.”

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