- Collaboration to build global-standard platform for plasmid and virus manufacturing in China
- Company plans to provide comprehensive products, services and training to GenScript on manufacturing capability development
Merck KGaA, Darmstadt, Germany, a leading science and technology company and leader in genome editing, today announced the signing of a non-binding Memorandum of Understanding with GenScript for a strategic alliance focusing on plasmid and viral vector manufacturing.
“Manufacturing of high-quality plasmid and viral vectors is one of the most critical components in the commercialization of cell and gene therapy,” said Udit Batra, member of the Executive Board and CEO, Life Science at Merck KGaA, Darmstadt, Germany. “As we are one of the world’s largest manufacturers of viral vectors, this collaboration will give GenScript access to our leading experience of nearly three decades of experience in gene and cell therapy manufacturing.”
“We are excited about the planned collaboration with Merck KGaA, Darmstadt, Germany to better serve our local and overseas customers with cGMP manufacturing facilities, and to accelerate the drug commercialization process,” said Daniel Wang Dongliang, vice president of Operations, Biologics Department, at GenScript.
The parties envision an alliance that will accelerate the industrialization and commercialization of cell and gene therapy in China. GenScript, a leading biotech company headquartered in Nanjing, China, aims to create a global-standard platform of plasmid and virus manufacturing service in the country. Merck KGaA, Darmstadt, Germany plans to provide GenScript with comprehensive products, training and consulting services covering process design, facility concept design and quality management system set-up from lab development to large-scale GMP manufacturing.
Merck KGaA, Darmstadt, Germany is among only a few manufacturers that have an industrialized process to make viral vectors. To create personalized therapy products, genes are delivered into immune cells using viral vectors, such as the ones that the company produces. It offers a unique combination as a contract manufacturing organization, serving other companies to provide services, and as a bioprocess manufacturing equipment maker.
A confluence of demand, growth and subsequent need to scale the cell and gene therapy market in China is an important driver for Merck KGaA, Darmstadt, Germany to deliver its expertise to this region. According to clinicaltrials.gov, China is the world-leader in terms of where gene-modified cell therapy clinical trials are conducted. Today, more than 130 companies in China are developing cell and gene therapies ranging from chimeric antigen receptor T cell therapy (CAR-T) / T cell receptor therapy (TCR-T) and adeno-associated virus (AAV) to oncolytic virus1. Moreover, 28 cell and gene therapy Investigational New Drug (IND) applications2 were submitted in China between Dec. 2017 – Dec. 2018 with more than a third already approved for clinical trials.
Merck KGaA, Darmstadt, Germany plans to provide a complete set of process products, services and staff training to support GenScript in building a world-class plasmid and viral vector manufacture platform to accelerate the industrialization of cell and gene therapy in China.
1) HSmap report 2017 – Chinese Gene Therapy Industry Atlas
2) Source: Yaozhi database
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