Instant Report

Date: 02-Mar-2021

Merck To Develop And Manufacture Therapeutics Of Monoclonal Antibody Drugs For Alteogen

Merck, a leading science and technology company, announced an agreement with Alteogen, of South Korea, providing late-stage CDMO services through Merck’s BioReliance End-to-End Solutions. Alteogen selected Merck to develop and produce recombinant biologics for the development and clinical evaluation of next-generation therapeutics of monoclonal antibody drugs.

“There is growing demand for the subcutaneous route of administration, as it enables self-medication, improves quality of life and reduces health care costs,” said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. “This agreement supports large-volume subcutaneous administration of biologics that would otherwise be administered as an IV infusion. This advances Merck’s strategy of providing breakthrough, next-generation biologics for novel modalities.”

Merck will provide Alteogen with late-stage CDMO services, including the transfer of Alteogen’s existing process to Merck’s GMP facility in Martillac, France, for the development and production of materials for novel therapeutics and their clinical evaluation.

As a full-service biologics CDMO, Merck’s BioReliance End-to-End Solutions offers deep expertise and flexible, custom solutions. Its services are used at all stages of development and manufacturing for recombinant proteins, including monoclonal antibodies, bi-specifics, antibody-drug conjugates or fusion proteins. Merck’s BioReliance End-to-End Solutions spans from mammalian cell line and process development to media and feed screening, master cell banking, scale up and GMP clinical and commercial drug substance manufacturing. Analytical methods development, validation and testing are all done in house.

With more than 30 years’ experience in process development and 25 years in GMP manufacturing, Merck has helped bring more than 260 biologics to market and has released more than 80 GMP drug substance batches since 2012 across a range of molecules and scales. Merck’s biologics CDMO has a global network of three facilities in Europe, the United States and China.