- Company’s first end-to-end center outside of Europe
- Accelerates clinical development from molecule to commercial production
BILLERICA, Mass., Sept. 22, 2017 /PRNewswire/ -- MilliporeSigma today announced the opening of its first BioReliance® End-to-End Biodevelopment Center in the Asia Pacific (APAC) region. Located in Shanghai, China, the center will provide a full range of process development capabilities and services, including cell line development, upstream and downstream process development and non-GMP clinical production.
“Our new BioReliance® End-to-End Biodevelopment Center will host small-scale drug manufacturers working on early-phase clinical trials,” said Udit Batra, CEO, MilliporeSigma. “MilliporeSigma has 30 years of process development experience and a track record of delivering robust clinical production process and clinical material within nine to 12 months. We look forward to advancing scientific discovery and innovation in China and beyond.
The Shanghai center is designed to meet the specific needs of customers in the APAC region. Staffed by local process scientists and engineers, the center will provide an integrated suite of services for biopharmaceutical companies in China and across APAC to accelerate clinical drug development from molecule to commercial production. Customers will get full support, not only with process development or production, but also with regulatory, quality and training.
“MilliporeSigma is a leading solutions provider,” said Dr. Chengbin Wu, founder and CEO, EpimAb Biotherapeutics, a privately held start-up company dedicated to generating novel bi-specific antibody therapeutics in oncology and immune-oncology based on its proprietary FIT-Ig (Fabs-In-Tandem) platform. “The opening of this center will provide biopharma and emerging biotech companies like us access to the latest technologies and experienced scientists, helping us in accelerating our drug development and providing more affordable medicine to patients.”
MilliporeSigma’s end-to-end global team has a track record of executing nearly 240 large molecule projects, ranging in scale from three to 2,000-liters. Early-stage companies with limited resources and infrastructure can benefit from MilliporeSigma’s expertise and experience in process development and GMP clinical manufacturing to advance their early clinical development programs. Additionally, MilliporeSigma’s end-to-end approach can facilitate and accelerate scaling, process and analytical method validation and technical transfer of an entire process to a customer-designated location.
MilliporeSigma’s end-to-end offering delivers important benefits and addresses key challenges for biopharmaceutical companies at all stages of molecule development and commercialization in any geography.
MilliporeSigma’s BioReliance® End-to-End Biodevelopment Center in Martillac, France, is a fully operational, single-use, GMP facility for manufacturing clinical-stage batches. Equipped with a full suite of MilliporeSigma technologies, including the 2000-liter single-use Mobius® bioreactor, Martillac offers biopharma companies a complete solution to support their clinical development programs.
MilliporeSigma’s BioReliance® End-to-End Biodevelopment Center in Burlington, Massachusetts, USA will provide a full range of process development capabilities and services. This includes cell line development services and both upstream and downstream process development, as well as non-GMP clinical production.
This new investment in China marks another milestone for MilliporeSigma in one of Asia’s most dynamic biotech markets. In November 2016, the company announced a $300 million production value chain investment in Nantong, dedicated to both the production of pharmaceuticals on China’s Essential Drug List and the manufacture of a range of innovative products and services for the pharma, biopharma and life sciences industries.
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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 20,000 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, 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 15 billion in 2016. 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. The company 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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SOURCE MilliporeSigma
