- Includes scale-up and GMP manufacturing of drugs in late-stage development
- Antibody targets advanced, refractory brain tumors in pediatric patients
BILLERICA, Mass., Aug. 1, 2016 /CNW/ -- MilliporeSigma will provide its Provantage® End-to-End development and manufacturing services to Y-mAbs Therapeutics, Inc. in support of Y-mAbs' monoclonal antibody in late stage clinical development.
The antibody, targeting refractory leptomeningeal tumor neuroblastoma and diffuse intrinsic pontine glioma, is a potential breakthrough treatment for pediatric patients. Following transfer of Y-mAbs' lead cell line to MilliporeSigma, services will include scale-up and GMP manufacturing of an antibody currently in late stage clinical development.
"Pediatric brain cancer is an especially challenging therapeutic area that comes with an extreme sense of urgency," said Udit Batra, CEO, MilliporeSigma. "Through our Provantage® services, which offer a templated, nimble approach to development and manufacturing, we expect to accelerate progress of this innovative therapeutic for patients in need."
"Through our agreement with MilliporeSigma, Y-mAbs takes a major step towards our commitment of making these breakthrough pediatric treatments available to children with advanced and life-threatening cancers,"said Thomas Gad, Y-mAbs' Founder, President and Head of Business Development and Strategy. "We expect to take delivery of cGMP drug product for our planned clinical trials by first half of 2017, and we are committed to making this leading immunotherapy product available to patients with life-threatening diseases worldwide."
MilliporeSigma's Provantage® End-to-End solution is a comprehensive suite of products and services enabling biopharmaceutical companies to accelerate the progression of molecules into the clinic and toward commercialization. The turnkey package includes process development, cGMP manufacturing, facility design, equipment for pilot plant production, process and equipment training, technology transfer, equipment qualification and set-up for commercialization.
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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 19,000 employees and 65 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Udit Batra is the global chief executive officer of MilliporeSigma.
Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.
Merck KGaA of Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 12.85 billion in 2015. Around 50,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.
Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the name and the trademark "Merck" internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD performance materials.
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