Foundation for future commercial supply of CG01 secured with delivery of three Master Cell Banks
Cobra Biologics, part of the Cognate BioServices family, an international CDMO manufacturer of biological materials and pharmaceuticals, and CombiGene AB (publ), the leading gene therapy company in the Nordic region, today 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."
About Cobra Biologics Cobra Biologics, together with its parent company Cognate BioServices, is a leading international contract development and manufacturing organisation (CDMO) providing the highest quality development and manufacturing services for the cell and gene therapy fields, ranging from early stage development and pre-clinical services to clinical and commercial supply. Cobra and Cognate service an international customer base from its manufacturing and development facilities in the UK, Sweden, and the US.
Each of the Company’s GMP approved facilities are tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract development and manufacturing services for the clinical trial and the commercial markets.
As a trusted provider and a key partner in the drug development and commercialisation process, we take pride in our manufacturing excellence and comprehensive range of services to the pharmaceutical and biotech industries.
Cobra is supported by leading shareholder EW Healthcare Partners, as well as Medivate Partners, Blackrock, and a Middle Eastern Sovereign Wealth Fund, who continue supporting the business and its expansion activities.
About CombiGene CombiGene's vision is to offer patients affected by severe life-changing diseases opportunities for a better life through innovative gene therapies. CombiGene's business concept is to develop effective gene therapies for serious diseases that today lack adequate treatment methods. Research assets are taken in from a network of external researchers and developed further up to clinical concept verification. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while CombiGene may drive the development and commercialization in-house for medicines aimed at limited patient populations. The company is public and listed on the Nasdaq First North Growth Market and the company's Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99, email@example.com.