Darmstadt, Germany, March 20, 2019 /PRNewswire/ -- Leading science and technology company Merck announced today that it has signed a non-binding memorandum of understanding with Chinese biotechnology company GenScript to establish a strategic alliance focused on the manufacturing of plasmids and viral vectors.
Udit Batra, Member of the Executive Board of Merck KGaA and CEO of Life Science, stated, “The manufacturing of high-quality plasmids and viral vectors is a most critical component in the commercialization of cell and gene therapies. As one of the world’s largest manufacturers of viral vectors, this collaboration will enable GenScript to leverage our nearly 30 years of leading expertise in the manufacturing of cell and gene therapy products.”
Daniel Wang Dongliang, Vice President of Operations for the Biologics Division at GenScript, stated, “We are pleased to plan a collaboration with Merck to better serve our domestic and overseas customers with our cGMP (current Good Manufacturing Practice) manufacturing facilities and to accelerate the drug commercialization process.”
The alliance envisioned by the two partners will help accelerate the industrialization and commercialization of cell and gene therapies in China. GenScript, a leading biotechnology company headquartered in Nanjing, China, plans to establish a global standard platform for plasmid and viral vector manufacturing services in China. Merck KGaA plans to provide GenScript with comprehensive products, training, and consulting services covering process design, facility conceptual design, and quality management system establishment, spanning from laboratory development to large-scale GMP (Good Manufacturing Practice) manufacturing.
Merck is one of the few manufacturers with industrialized processes for producing viral vectors. To create personalized therapeutic products, genes need to be delivered into immune cells using viral vectors—such as those produced by Merck. Additionally, Merck offers a unique product portfolio as both a contract manufacturing organization (CMO) and a manufacturer of bioprocessing equipment.
The demand, growth, and subsequent expansion requirements of China’s cell and gene therapy market are significant drivers compelling Merck to provide its expertise in China. According to clinicaltrials.gov, China is a global leader in conducting clinical trials of genetically modified cell therapies. Currently, more than 130 companies in China are developing cell and gene therapies ranging from chimeric antigen receptor T-cell (CAR-T) therapies and T-cell receptor-engineered T-cell (TCR-T) therapies to adeno-associated virus (AAV) vectors and oncolytic viruses [1]. Furthermore, 28 new drug applications for cell and gene therapies were submitted in China between December 2017 and December 2018 [2], with more than one-third of these applications approved for clinical trials.
Merck plans to provide a comprehensive portfolio of process products, services, and personnel training for this collaboration, in order to support GenScript in building a world-class plasmid and viral vector manufacturing platform, thereby helping to accelerate the industrialization of cell and gene therapies in China.
Reference
[1] 2017 HSmap Report—Panoramic View of China's Gene Therapy Industry [2] Source: YAOZHI Database
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