Merck to Manufacture Next-Generation Biotherapeutics for Alteogen

• Merck to provide biologics contract development and manufacturing services through BioReliance^® End-to-End Solutions
• Includes late-stage development, scale up and Good Manufacturing Practice (GMP) manufacturing of novel biologics supporting therapeutic antibody formulation
• Underscores growing importance of differentiated service offering and leverages Contract Development and Manufacturing Organization (CDMO) network in three regions

Darmstadt, Germany, February 25, 2021—  Merck, a leading science and technology company, today announced an agreement with Alteogen, Inc., 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.

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About Alteogen Inc.
Alteogen lnc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen’s portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed proprietary recombinant human hyaluronidase enzyme utilizing HybrozymeTM technology, which enable the large volume subcutaneous administration of drugs that are typically administered as an IV injection. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).