Merck’s Millipore CTDMO Services and Synplogen will integrate their capabilities to provide streamlined development, manufacturing and testing for viral vector gene therapies for Japan
The collaboration includes licensing Merck’s VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform, which the company says will 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.
Meanwhile, Merck will also 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).
“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.”
Synplogen is a DNA synthesis startup spun out of Kobe University in 2017. Combining its proprietary OGAB techniques with cutting edge genetic engineering, information science and robotics, Synplogen provides a variety of services including DNA synthesis, DNA library development and synthesis and viral vector development for gene therapy applications.
Kazuhiko Yamamoto, CEO of Synplogen, said: “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.”