Merck, GenScript Join Hands To Accelerate Cell & Gene Therapy in China
19 MAR 2019 | DARMSTADT, GERMANY: In an announcement made by Merck, it has entered into a non-binding Memorandum of Understanding with GenScript a China-based biotech company with an aim to accelerate Cell and Gene Therapy Industrialization in China. The pact primarily focuses on the plasmid and viral vector manufacturing.
Udit Batra, Member of the Merck Executive Board and CEO, Life Science said, “As we’re one of the world’s biggest manufacturers of viral vectors, this collaboration provides GenScript accessibility to our leading experience of almost 3 years in cell and gene therapy production.”
“We’re excited about the planned collaboration with Merck to serve our local and international clients with cGMP manufacturing facilities and to quicken the drug commercialization process,” stated Daniel Wang Dongliang, vice president of Operations,” Biologics Department, in GenScript.
The parties picture an alliance that will accelerate the industrialization and commercialization of cell and gene therapy in China. GenScript, a major biotech firm headquartered in Nanjing, China, aims to create a global-standard platform of plasmid and virus production service in the country. Merck intends to give GenScript with comprehensive products, training and consulting solutions covering processdesign, center concept layout, and quality management platform set-up from laboratory development to large-scale GMP manufacturing.
Merck is among only a few manufacturers that have an undercover procedure to make viral vectors. To create personalized therapy products, genes have been delivered into resistant cells with viral vectors, such as the ones which Merck produces. The business offers a unique combination as a contract manufacturing organization and as a bioprocess manufacturing equipment maker.
A confluence of demand, growth and a subsequent requirement to scale the cell and gene therapy market in China is an important driver for Merck to deliver its expertise to the area. 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 growing cell and gene therapies ranging from chimeric antigen receptor T cell treatment (CAR-T) / T-cell receptor therapy (TCR-T) and also adeno-associated virus (AAV) into oncolytic virus1. Moreover, 28 cells and gene treatment Investigational New Drug applications2 were submitted in China between Dec. 2017 — Dec. 2018 with over a third already approved for clinical trials.
Merck intends to provide a whole set of process goods, services, and personnel training to support GenScript in developing a world-class plasmid and viral vector production platform to accelerate the industrialization of their cell and gene therapy in China.