TaiMed Biologics has made a breakthrough in its CDMO (Contract Development and Manufacturing Organization) business, announcing on the 30th that it has signed an agreement with a U.S. client for the production of clinical trial antibody drugs. This marks TaiMed’s first CDMO contract from an overseas client. Following the formal signing of the agreement, the two parties will initiate technology transfer, followed by analytical testing and related manufacturing processes.

Due to confidentiality agreements, specific commercial terms of the contract have not been disclosed.

CEO James Chang stated that this collaboration with a U.S.-based client represents a significant milestone for TaiMed. It not only demonstrates international recognition of the company’s professional CDMO capabilities but also injects new momentum into its operational growth.

In terms of technical capacity, TaiMed’s Zhubei facility for protein and antibody drug manufacturing is equipped with state-of-the-art infrastructure and ample production capacity, featuring multiple bioreactors ranging from 50 to 2,000 liters to meet clinical and commercial manufacturing needs. The facility has already successfully completed multiple antibody drug production runs.

TaiMed’s Zhubei plant passed inspections by the U.S. FDA in both 2022 and 2023 with no deficiencies, underscoring the company’s robust capabilities in process development, scale-up technology transfer, and GMP batch manufacturing.

On the operational front, in addition to the ongoing sales of Trogarzo, the CDMO business is expected to drive further business development and contribute positively to TaiMed’s performance. This also reinforces the company’s comprehensive CDMO service model—covering everything from process development to commercialization—anchored in Taiwan and now extending into the global market.

Resource: 海外拓展報捷 中裕與美國客戶簽訂CDMO訂單