News Release
Synplogen Signs MOU with Merck to Promote Process Development and Manufacturing of Viral Vectors
for Gene Therapy
KOBE, Japan, December 9, 2022 - Synplogen Co., Ltd. (Head office: Nada-ku, Kobe; President and CEO:
Kazuhiko Yamamoto; hereinafter referred to as "Synplogen"), a biotech startup spun out of Kobe University,
has signed an MOU with Merck (hereinafter referred to as "Merck") to collaborate on the processdevelopment and GMP manufacturing of viral vectors for gene therapy.
Synplogen provides design, development, and analysis services for high-quality, cost-effective viral vectors
for gene therapy (Gene Therapy Biofoundry Services), utilizing its proprietary ultra-long DNA synthesis
technology. At its Kobe R&D Center, Synplogen can offer a wide range of services to meet customer needs,
including DNA synthesis, plasmid DNA mass preparation, viral vector production, process development,characterization and quality testing, and support for technology transfer to GMP-compliant manufacturing
facilities.
Merck is one of the world's leading science and technology companies providing viral vector manufacturingsolutions covering process development, manufacturing and quality testing of adeno-associated virus(AAV) and lentivirus (LV) vectors, and is a leading CTDMO and technology development company.
“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 (CMC) development to GMP manufacturing and potentiallyexpand the business globally, by licensing our proprietary technologies to overseas companies,” said
Kazuhiko Yamamoto, President and CEO of Synplogen Co., Ltd.
“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 thetargeted template and manufacturing for viral vector in order to bring these life-changing therapies to morepatients.”
Based on the MOU, Synplogen will receive technical consulting and support from Merck for thedevelopment of manufacturing processes and quality testing methods for gene therapeutic viral vectors
from upstream to downstream processes, CTDMO services for investigational and commercial productionof gene therapeutic viral vectors, as well as demonstrations and practical training through the M Lab TM

Collaboration Center.
Merck's VirusExpress® 293 adeno-associated virus production platform is expected to shorten the time toinvestigational manufacturing for AAV vectors and accelerate the timeline of pipeline development for
Synplogen's customers to move into clinical trials.

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-OGABTM
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, andanalysis of high-quality, cost-effective viral vectors for gene therapy at our Kobe R&D Center, as abiofoundry specializing in gene therapy.
Head Office:

1-1 Rokkodai-cho Nada-ku, Kobe Japan

Established:

February 2017

Representative:

Kazuhiko Yamamoto, President and CEO

Capital:2,325.68 million yen (including capital reserve)

Business:

Custom DNA synthesis and biofoundry services for gene therapy

URL:

https://www.synplogen.com/

About Merck
Merck, a leading science and technology company, operates across life science, healthcare and electronics.
More than 60,000 employees work to make a positive difference to millions of people’s lives every day bycreating more joyful and sustainable ways to live. From providing products and services that accelerate drug
development and manufacturing as well as discovering unique ways to treat the most challenging diseases
to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of €19.7 billion in 66 countries.
About Merck Ltd.
Merck Ltd. was founded in 1968 as the Japanese subsidiary of Merck. Merck Ltd. is engaged in products
and services related to life sciences, including basic bioscience research, pharmaceutical manufacturing anddrug discovery. Merck Ltd. is responsible for the life science business and Merck's administrative functions.
For more information about Merck Ltd., please visit https://www.merckgroup.com/jp-ja.
Contact:
Synplogen Co., Ltd.
Email: info@synplogen.com