MilliporeSigma has signed a collaboration agreement with China-based GenScript focusing on plasmid and viral vector manufacturing.
 
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 aims to create a global-standard platform of plasmid and virus manufacturing service in the country. MilliporeSigma 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.
 
“Manufacturing of high-quality plasmid and viral vectors is one of the most critical components in the commercialization of cell and gene therapy, and we are one of the world’s largest manufacturers of viral vectors,” said Udit Batra, chief executive officer, MilliporeSigma. “This collaboration will give GenScript access to MilliporeSigma’s nearly three decades of experience in gene and cell therapy manufacturing.”
 
“We are excited about the planned collaboration with MilliporeSigma 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, GenScript.
 
A confluence of demand, growth and subsequent need to scale the cell and gene therapy market in China is an important driver for MilliporeSigma 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. In addition, 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.
 
MilliporeSigma 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.