Merck To Collaborate with GenScript to Accelerate Cell and Gene Therapy Industrialization in China

On Mar 21, 2019

Merck announced the signing of a non-binding Memorandum of Understanding with Chinese biotech company 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 Merck Executive Board and CEO, Life Science. “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 in gene and cell therapy manufacturing.”

Merck is collaborating with Chinese biotechnology company GenScript for production of plasmids and viral vectors for gene therapies in China

“We are excited about the planned collaboration with Merck 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 Development Business Unit, 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 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 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 Merck produces. The company offers a unique combination as a contract manufacturing organization 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 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 virus. Moreover, 28 cell and gene therapy Investigational New Drug applications were submitted in China between Dec. 2017 – Dec. 2018 with more than a third already approved for clinical trials.

Merck 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.