DM Bio said it has signed a CDMO (contract development and manufacturing organization) contract with Abion for an antibody treatment new being developed by the latter.
Under the accord, DM Bio will be manufacturing the drug substance of the antibody treatment as well as developing its manufacturing process to enhance productivity, it said. DM Bio is a joint-venture biopharmaceutical company between Dong-A Socio Group and Meiji Seika Pharma of Japan.
DM Bio said it has production facilities that satisfy current good manufacturing practice (cGMP) standards set by the U.S. the Food and Drug Administration for antibody biopharmaceuticals. The company’s facilities also have received GMP approval from the Japan Pharmaceuticals and Medical Devices Agency.
It is focusing on the CDMO business as well as biosimilars jointly developed by Dong-A Socio Group and Meiji Seika Pharma.
Last year, DM Bio received the consulting service from Lachman of the United for its GMP system to meet the FDA standards and expand its CDMO domain to the contract research organization (CRO) business. It also established a research center for the same purchase.
Major pipelines of Abion, a developer of targeted anticancer new medicine, include ABN401, a treatment for solid cancer with c-Met mutations, ABN501, a Claudin antibody drug, and ABN90X, a therapy for biological infectious disease disaster. ANB401 is in phase 1/2a clinical trials in Australia and Korea.
“DM Bio is conducting its CDMO business in earnest by signing a contract with Abion following contract with a bio-venture company,” an official of DM Bio said. “We will expand CDMO contracts from domestic and foreign biopharmaceuticals based on global-level manufacturing facilities and systems.”
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