MilliporeSigma to Provide Provantage? End-to-End Development and Manufacturing Services to Y-mAbs for Lead Antibody Compound
- Includes scale-up and GMP manufacturing of drugs in late-stage development
- Antibody targets advanced, refractory brain tumors in pediatric patients
Billerica, Massachusetts, August 1, 2016 — 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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Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck KGaA, Darmstadt, Germany, generated sales of € 12.85 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the ?Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Merck KGaA, Darmstadt, Germany today announced that updated data from the ongoing, single-arm Phase II VISION study evaluating tepotinib* were published.