Cobra Biologics (Cobra), part of the Cognate BioServices family, an international CDMO manufacturer of biological materials and pharmaceuticals, and CombiGene AB (publ) (CombiGene), the gene therapy company in the Nordic region, have announced that Cobra has successfully produced master cell banks for the three plasmids used as starting material for CombiGene’s gene therapy CG01.
Critical to assuring ‘life time’ supply of therapeutic, this represents a further milestone in the future commercial manufacture of a drug candidate designed for the treatment of drug-resistant focal epilepsy.
The three master cell banks have been developed according to Good Manufacturing Practice (GMP). GMP-compliant cell bank production assures stable and uniform populations of cells are preserved as starting material for all future batches of the three plasmids and a sufficient supply of material is readily available for the life of the product.
Ensuring the quality and characteristics of the plasmids are identical at each individual production time, the master cell banks can thus be used each time CombiGene produces new plasmids for production of CG01 whether that be for future clinical studies or commercial production.
This follows the recent milestone announcement that Cobra had successfully produced and supplied all three of the plasmids that form the starting material and are key components in the production of CombiGene’s gene therapy vector, CG01. This gene therapy vector is tasked with “transporting” CG01’s active substances NPY and Y2 into the patient’s brain tissue.
Karin Agerman, Chief Research and Development Officer, CombiGene: “The fact that we now have the three master cell banks in place means that all further production of plasmids, used in the manufacturing of CG01, for the final preclinical and clinical studies as well as future treatments, take place from a stable and safe basis.”
Peter Coleman, Chief Executive, Cobra Biologics: “The generation of DNA cell banks is the vital first step in the product commercialisation journey. Cobra is excited to continue that journey with CombiGene and their CG01 epilepsy gene therapy drug candidate.”