Merck 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 integrate their capabilities 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 at Merck’s Life Science business sector in Japan. “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 Merck’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 Merck’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 Merck 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, Merck will offer technical support, training and process development and optimization at its M Lab Collaboration Center in Tokyo. Merck 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.