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18 Aug 2020

Cobra Biologics completes production of master cell banks for epilepsy gene therapy drug candidate

This milestone secures future production of CombiGene's CG01 drug candidate to treat drug-resistant focal epilepsy.

Cobra Biologics, part of the Cognate BioServices family, an international CDMO manufacturer of biological materials and pharmaceuticals, has successfully produced master cell banks for the three plasmids used as starting material for CombiGene’s gene therapy CG01.

Critical to assuring ‘lifetime’ supply of therapeutic, this represents a further milestone in the future commercial manufacture of a drug candidate designed to treat drug-resistant focal epilepsy.

The three master cell banks have been developed according to Good Manufacturing Practice (GMP), which 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, a leading gene therapy company in the Nordic region, 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.

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."

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