Wednesday, March 20, 2019
Merck , a leading science and technology company, today announced the signing of a non-binding Memorandum of Understanding with Chinese biotechnology company GenScript to form a strategic alliance with the aim of making plasmids and viral vectors.
"The manufacturing of high quality plasmids and viral vectors is one of the most critical components in the marketing of cellular and genetic therapies," said Udit Batra , a member of the executive board of Merck and chief executive officer of the biological sciences. "As we are one of the world's largest manufacturers of viral vectors, this collaboration will give GenScript access to our pioneering experience of nearly three decades in the manufacture of gene and cell therapies."
"We are excited about the planned collaboration with Merck to better serve local and foreign customers, with the current manufacturing facility of good manufacturing practices (cGMP) and to accelerate the drug marketing process," said Daniel Wang Dongliang , Vice chief operating officer of GenScript's Biological Development Business Unit.
The parties envisage a partnership that will accelerate the industrialization and commercialization of gene therapy in China . GenScript, the leading biotechnology company based in Nanjing , China , aims to create a world-class platform for plasmid and virus manufacturing services in the country. Merck plans to provide GenScript with product coverage, training and consulting services that include process design, the conceptual design of facilities and the configuration of the quality management system, from laboratory development to manufacturing based on good practices on a large scale.
Merck is among the select manufacturers that use an industrialized process of producing viral vectors. To develop customized therapeutic products, the genes are delivered to the cells of the immune system, using viral vectors, such as those that Merck manufactures. The company offers a unique combination being a contractual manufacturing organization and manufacturer of equipment for the creation of bioprocesses.
The confluence of demand, growth and the consequent need to expand the market for cellular and gene therapy in China is one of the important factors for Merck to provide its specialized knowledge to this region. According to clinicaltrials.gov, China is the world leader in terms of where clinical trials of modified gene therapies are conducted. Today, more than 130 Chinese companies are developing gene and cell therapies, ranging from T cell therapy with chimeric antigen receptor (CAR-T) / cell receptor therapy T (TCR-T) and adeno - associated virus ( AAV) to oncolytic virus 1 . In addition, in China, there are 28 requests for new investigational drugs for cellular and genetic therapies 2 made between December 2017 and December 2018, with more than one-third already approved for clinical trials.
Merck plans to provide a complete set of process products, services and personnel training to support GenScript in developing a high-level plasmid and viral vector fabrication platform to accelerate the industrialization of cellular and genetic therapies in China .