Plasmid DNA is a critical starting material in the development of many advanced therapies.
Following the acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021, Charles River has expanded its comprehensive cell and gene therapy portfolio to include CDMO capabilities spanning viral vector, plasmid DNA and cellular therapy production for clinical through to commercial supply.
With the support of those plasmid DNA manufacturing services, Ziphius said it is well positioned to progress toward clinical testing and further validation of its self-amplifying RNA (saRNA) vaccine candidates.
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, according to the parties.
Ziphius’ lead compound, ZIP1642, is a COVID-19 vaccine candidate that has been evaluated in preclinical studies. The Ghent, Belgium based company also has a portfolio of next generation vaccine candidates targeting infectious diseases and gene supplementation therapies.
“The advancement of saRNA technologies is an exciting avenue for the development of vaccines and therapeutic programs,” noted Kerstin Dolph, senior vice president, global biologics, Charles River.
In March, we reported on Charles River’s expansion of the organization's capacity for plasmid DNA and viral vector development in Europe, with the company investing £7m (US$9.2m) in that UK build. The enhancement would quadruple Charles River’s manufacturing scope for that starting material.
Earlier this month, Charles River’s announced its extended partnership with ASC Therapeutics to manufacture ASC618, a second-generation gene therapy for hemophilia A. The partners have been working together since 2019 on GMP-virus manufacturing and have established processes for AAV production and purification.