The life science business of Merck KGaA, Darmstadt, Germany, one of the world’s leading science and technology companies, is committed to advancing the development and commercialization of new medicines for patients in need. The company offers contract development and manufacturing (CDMO) services through BioReliance® End-to-End Solutions. They are a full-service biologics CDMO offering deep expertise and flexible, custom solutions at all stages of development and manufacturing for your monoclonal antibody, bispecific antibody, ADC or fusion protein. Their services span from mammalian cell line and process development to media and feed screening, master cell banking, scale up and commercial drug substance manufacturing. Plus, their analytical methods development, validation and testing are all done in house.
MilliporeSigma's three facilities across the USA, Europe and China, as well as their industry-leading single-use technology give them the flexibility to reserve slots for small batches or increase capacity for large ones in alignment with their customers’ timeline.
The company has a long history of contract development and manufacturing success. Their biodevelopment center in Martillac, France, established in 1987 as a CDMO, was acquired as the discovery, development, and manufacturing function for the Healthcare business of Merck KGaA, Darmstadt, Germany. The manufacturing site, which has been audited and approved by the French health authority (ANSM), obtained a certificate of GMP compliance in 1995. In addition, the site has been visited by the U.S. FDA, UK and Australian authorities. It was upgraded to a fully single-use platform in 2011 when the CDMO returned to offering services for external clients. This location offers pilot production up to 200L and clinical and commercial production up to 4000L with eight single-use Mobius® bioreactors and three manufacturing suites. To ensure that projects are positioned for success from the earliest stages, the CDMO has extensive experience working with a range of popular cell lines including development of CHOZN® GS -/- and CHOZN® K1, proprietary cell lines to optimize development of biologics.
In 2017, the CDMO expanded to better serve clients around the world, leveraging identical technologies in each location to facilitate tech transfers. New biodevelopment centers opened in Boston and Shanghai; both offer clinical production up to 200L. In 2020, a 3700 m2 facility in Shanghai opened and has obtained a certificate of GMP compliance. A 2800 m² commercial manufacturing expansion of the GMP-certified Martillac, France facility will be available in 2022.
With more than 30 years’ experience in process development and 25 years in manufacturing, the BioReliance® End-to-End Solutions team, has helped to bring more than 260 biologics to market and they have released 80+ drug substance batches since 2012 over a range of molecules and scales.
“We take the time to understand our clients’ goals and make them ours. We ask questions about how fast a client needs to go and the acceptable level of risk,” explains Sébastien Ribault, Ph.D. VP and Head of End-to-End Solutions. “From those insights, we establish the strategy and design custom solutions, tailored to each molecule and project. Being adaptable by nature, we integrate our activities with existing or new partners involved in the project, helping to ensure streamlined progress towards every milestone.”