MoU: Merck & Synplogen for Gene Therapy

NEWS RELEASE

• Company’s Millipore^® CTDMO Services (Contract Testing, Development and Manufacturing Organization) to streamline viral vector development and production in Japan
• Collaboration includes VirusExpress^® Platform to accelerate development and clinical research
• MilliporeSigma to provide hands-on training to Synplogen scientists at M Lab™ Collaboration Center in Japan

Burlington, Massachusetts, December 8, 2022 – MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, has signed a non-binding Memorandum of Understanding (MoU) with Synplogen, a startup spun out of Kobe University's Graduate School of Science, Technology and Innovation. Both companies aim to provide streamlined development, manufacturing and testing for viral vector gene therapies for Japan.

“With nearly 30 years’ experience in cell and gene therapy, we look forward to collaborating with Synplogen to further the development and manufacturing of viral vectors in Japan,” said Isao Hatano, Head of Process Solutions, Japan, Life Science business sector of Merck KGaA, Darmstadt, Germany. “Our work together will focus on developing the targeted template and manufacturing for viral vectors in order to bring these life-changing therapies to more patients.”

The collaboration also includes licensing MilliporeSigma’s VirusExpress^® 293 Adeno-Associated Virus (AAV) Production Platform. It will enable Synplogen to increase the speed to clinical manufacturing, while reducing process development time and costs. The approach will leverage the company’s Millipore^® CTDMO Services facility in Carlsbad, California, USA, which opened in 2021 to support large-scale commercial and industrial manufacturing of viral and gene therapy products.

“Synplogen has been providing customers with the technologies and services including DNA synthesis, cell, process and test method development necessary for gene therapy products, a market that has grown dramatically in recent years. Our collaboration with MilliporeSigma will enable us to provide a full range of services from Chemistry, Manufacturing and Control development to GMP manufacturing and potentially expand the business globally, by licensing our proprietary technologies to overseas companies,” said Kazuhiko Yamamoto, Representative Director and CEO of Synplogen Co., Ltd.

As part of the MoU, MilliporeSigma will offer technical support, training and process development and optimization at its M Lab™ Collaboration Center in Tokyo. The company operates M Lab™ Collaboration Centers in nine countries worldwide, where its scientists and engineers provide customers with opportunities for collaboration, technical guidance, and education in a fully simulated bioprocessing manufacturing lab environment.

About Synplogen
Synplogen Co., Ltd. is a synthetic biology startup company founded in 2017 and originated from Kobe University. Utilizing its proprietary DNA synthesis technologies "OGAB method" and "Combi-OGAB method", the company is capable of synthesizing ultra-long and complex DNA and constructing DNA libraries with various combinations. We also provide one-stop solutions for the design, development, and analysis of high-quality, cost-effective viral vectors for gene therapy at our Kobe R&D Center, as a biofoundry specializing in gene therapy. URL：https://www.synplogen.com/