MilliporeSigma To Manufacture Next-Generation Biotherapeutics For Alteogen

• MilliporeSigma 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

MilliporeSigma announced an agreement with Alteogen, Inc., of South Korea, providing late-stage CDMO services through MilliporeSigma’s BioReliance^® End-to-End Solutions. Alteogen selected MilliporeSigma 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 at MilliporeSigma. “This agreement supports large-volume subcutaneous administration of biologics that would otherwise be administered as an IV infusion. This advances MilliporeSigma’s strategy of providing breakthrough, next-generation biologics for novel modalities.”

MilliporeSigma will provide Alteogen with late-stage CDMO services including the transfer of Alteogen’s existing process to MilliporeSigma’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, MilliporeSigma’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. MilliporeSigma’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, MilliporeSigma 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. MilliporeSigma’s biologics CDMO has a global network of three facilities in Europe, the United States and China.

All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

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 Hybrozyme^TM 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).

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 some 22,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of €16.2 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.