Merck and Transcenta Collaborate to Advance Continuous Biomanufacturing, Make the 'Facility of the Future' a Reality

Companies to co-develop a first-of-its-kind,single-use flow-through polishing system for GMP operation

Merck's continuous processing expertise to accelerate Transcenta's development,implementation of continuous bioprocessing platform

Collaboration expected to accelerate affordable access to therapeutics for patients in China and globally

SHANGHAI,Nov. 8,2020 --On November 7,Merck,a leading science and technology company,and Transcenta,a global biotherapeutics company,announced a strategic technology collaboration to implement continuous manufacturing for protein therapeutics.

From left to right: Frank Ye,Chief Operating Officer of Transcenta; Ian Carmichael,Vice President and Head of BioProcessing China,Life Science business of Merck

"Merck's commitment and extensive expertise in next-generation manufacturing uniquely positions us to help transform Transcenta's vision for a fully continuous manufacturing process into a reality," said Ian Carmichael,vice president and general manager of Bioprocessing,Life Science,at Merck in China. "Our joint effort reflects a shared commitment to advance BioProcessing 4.0 and continuous bioprocessing to accelerate access to health for patients in China and across the world."

Keynote speech by Ian Carmichael,Life Science business of Merck

This unique model of collaboration between supplier and customer brings the teams together in real time to convergesingle-use,continuous and digital bioprocessing technologies for the further development of Transcenta's integrated continuous bioprocessing (ICB) platform. As part of the initiative,Merck and Transcenta will co-develop a first-of-its-kind,single-use flow-through polishing system,one of the key elements of Transcenta's ICB Platform.

Keynote speech by Frank Ye,Chief Operating Officer of Transcenta

The first phase of this multi-year partnership will focus on developing and designing the process technologies,single-use system and automation,while the second phase will focus on an expanded scope of process and digital technologies to optimize a continuous manufacturing process. This highly collaborative relationship leverages Merck's BioContinuum™ Platform and extensive expertise in continuous processing to help realize Transcenta's vision to implement fully continuous bioprocessing in GMP manufacturing in China.

"To fulfill our mission to deliver high quality and affordable innovative biologics to patients around the world,Transcenta is advancing our highly productive ICB platform for the manufacturing of any protein biologics through process intensification,automation and power of continuous bioprocessing," said Chris Hwang,chief technology officer at Transcenta. "Merck's BioContinuum™ Platform and broad portfolio make them an ideal collaborative partner to help us accelerate and realize the potential of ICB."

Merck has been a key driver of the evolution toward continuous processing through its expanding BioContinuum™ Platform,which combines intensified,connected and continuous processing with software,automation and analytical technologies to help manufacturers reach their Bioprocessing 4.0 goals. Bioprocessing 4.0 refers to driving manufacturing forward by increasing digitilization and the interconnection of products,supply chains and business models. It is defined as a totally end-to-end connected bioprocess,in which all systems and equipment in the process are digitally connected. Merck was the first supplier to combine advanced process technologies with software,automation and analytics into a single environment with its Bio4C™ Software Suite.

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About Transcenta Holding Limited

Transcenta is a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery,development and manufacturing. With a Discovery and Translational Research Center in Suzhou,a Process and Product Development Center and Manufacturing Facility in Hangzhou,and Clinical Development Centers in Beijing,Shanghai,and Guangzhou in China and in Princeton,US,and External Partnering Center in Boston,Transcenta has established a global footprint. Currently,Transcenta has over 10 innovative pipeline molecules in oncology and select non-oncology areas. Upon the latest financing,the company has raised over $230 million from globally prominent investors. For more information,please visit www.transcenta.com.

About Merck

Merck,operates across healthcare,life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019,Merck generated sales of € 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada,where the business sectors of Merck operate as EMD Serono in healthcare,MilliporeSigma in life science,and EMD Performance Materials.