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MilliporeSigma Announces Collaboration with Biotheus to Accelerate Drug Submission and Approval Process for Biopharmaceutical Industry in China

News Release

  • Company to offer its first-to-market Blazar® Rodent Panel for virus testing
  • Reduces biosafety turnaround time by up to 80%
  • Reduces animal testing through molecular-based technology

Burlington, Massachusetts, November 7, 2022 – MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced a collaboration with Biotheus, a China-based biotech company focused on developing treatments for cancer and autoimmune diseases. Utilizing the Life Science business sector’s Blazar® Rodent Panel, Biotheus’ turn-around-time (TAT) of its cell line characterization reduced from around 60 days to 14 days.

“The pressure to shorten delivery times and reduce costs for biologics are driving an evolution in the biomanufacturing space,” said Marc Jaffré, Managing Director, China, Life Science business sector of Merck KGaA, Darmstadt, Germany. “We have a 75-year history of biosafety testing experience. With this state-of-the-art platform, the Blazar® Rodent Panel can support our biopharmaceutical clients in China to accelerate their scientific breakthroughs and produce safe, life-saving therapies faster.”

“The Blazar® Rodent Panel is one of the few technologies available on the market that will empower us in expediting approvals for IND and BLA in China and beyond,” said Xu Yingda, Vice President of Chemical Manufacturing and Control, Biotheus Inc. “We look forward to our continued collaboration in the development of novel drugs to treat cancer and inflammatory disease and expand our clinical trial activities worldwide.”

The award-winning Blazar® Rodent Panel can detect a much broader range of adventitious viruses compared to traditional Polymerase Chain Reaction methods as it targets conserved regions within virus families. The Blazar® Rodent Panel allows the biopharma industry to move away from using traditional animal experiments to detect rodent origin virus in the cell banks used in the production of the biologics. Introduced in 2020, it also reduces the use of animals in accordance with the 4Rs principles – replacement, reduction, refinement and responsibility.

About the Life Science business of Merck KGaA, Darmstadt, Germany

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 28,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

More than 64,000 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 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 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit www.emdgroup.com.

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