MilliporeSigma,life science business of Merck KGaA, 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’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.
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.