Collaboration to build global-standard platform for plasmid and virus manufacturing in China.
A strategic alliance between pharma giant, Merck and Chinese biotech company, GenScript, aim to accelerate the industrialisation and commercialisation of cell and gene therapy in China.
The manufacturing of high-quality plasmid and viral vectors is one of the most critical components in the commercialisation of cell and gene therapy.
Merck is among only a few manufacturers that have an industrialised process to make viral vectors.
To create personalised therapy products, genes are delivered into immune cells using viral vectors.
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 December 2017 to December 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 creating a global-standard platform of plasmid and virus manufacturing service in the country. [APBN]