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."
Related News
-
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News The 2024 Pharma Outsourcing Forecast: strategic partnerships across global landscapes
For the pharmaceutical industry, outsourcing drug development, manufacturing, and research operations to contract organisations is not just a passing trend – increasingly, the partnership between drug sponsor and drug vendor is one of vital impor... -
News Gerresheimer predicts weight-loss drug deals to account for 4% of yearly growth
Dietmar Siemssen, CEO of German primary packaging manufacturer Gerresheimer, states that approximately 4% of the company’s revenue growth each year to come from deals with drugmakers of weight loss and diabetes products, particularly GLP-1 class ... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Coronary drug-coated medical device receives US FDA approval
Boston Scientific announced the FDA approval of their medical device AGENT Drug-Coated Balloon (DCB) for the indication of coronary in-stent restenosis in coronary artery disease patients. -
News CPHI Online Webinar Series – Innovative Strategies for B2B Pharma Marketeers
On February 20, 2024, CPHI Online hosted a webinar on Innovative Strategies for B2B Pharma Marketeers. Featuring expert speakers from across the pharmaceutical value chain, this webinar delves into how B2B pharma marketeers can create better content to... -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance