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

• Collaboration to build global-standard platform for plasmid and virus manufacturing in China
• MilliporeSigma plans to provide comprehensive products, services and training to GenScript on manufacturing

Burlington, Massachusetts, March 19, 2019 — MilliporeSigma today 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, CEO, MilliporeSigma. “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.”

“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. 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.

MilliporeSigma 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 MilliporeSigma manufacturers. 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 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 virus1. Moreover, 28 cell and gene therapy Investigational New Drug applications2 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.

1 HSmap report 2017 – Chinese Gene Therapy Industry Atlas
2 Source: Yaozhi database

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About GenScript

GenScript Biotech Corp. is a world leader in the biological reagent service industry. Headquartered in Nanjing, China, the Group currently has a couple of R&D, production and operation centers in Nanjing and New Jersey, two production bases in Zhenjiang and Jinan, two European bases for its subsidiary Legend in Netherlands and Ireland, and a wholly-owned subsidiary in Japan. With the fast growth in developing biological reagents, the Company now expands its business into immunotherapy, contract development and manufacturing organization (CDMO), lab equipment and industrial microbiology applications. To support these businesses, it has established open and innovation-driven technological platforms, GMP facilities for pre-clinical drug discovery and pharmaceutical product development and a full-range industrial microbial R&D and industrialization platform for enzyme screening, GMP plasmid and virus production, antibody drug discovery (Bispecific antibodies technology; Hybridoma technology; Humanized Antibody technology; Phage display technology), genetic engineering, protein engineering and fermentation process optimization. The Company is uniquely positioned and well equipped to further fulfill its mission in making people and nature healthier through biotechnology.