Locus Cell Secures First International Phase III CDMO Partnership with Cambium Bio for Dry Eye Therapy
核心洞察
Taiwan-based regenerative medicine CDMO Locus Cell (搜索) has signed its first international Phase III manufacturing agreement with Australian biotech Cambium Bio (搜索) for Elate Ocular® (搜索), a dry eye disease therapy.
The partnership designates Locus Cell (搜索)'s Zhubei Smart GMP Facility as the manufacturing site, meeting FDA and GMP standards for both clinical and commercial production capabilities.
Cambium Bio (搜索) has also secured licensing rights with France's Benta SAS (搜索) for Middle Eastern and European markets, while Locus Cell (搜索) will handle all other international manufacturing.
Taiwan-based regenerative medicine contract development and manufacturing organization (CDMO) Locus Cell (搜索) has secured its first international Phase III manufacturing partnership through a Memorandum of Understanding (MOU) with Australian biotechnology company Cambium Bio (搜索). The agreement designates Locus Cell's Zhubei Smart GMP Facility as the manufacturing site for Cambium Bio's Elate Ocular® (搜索), a Phase III dry eye disease therapy currently under clinical trials in Taiwan, the United States, and Australia.
Strategic Manufacturing Partnership
Under the MOU, Cambium Bio (搜索) will entrust Locus Cell (搜索) with contract development and manufacturing responsibilities for Elate Ocular® (搜索)-related products under strict Good Manufacturing Practice (GMP) standards. The technology originates from Cambium's parent company, Zheng Yang Biomedical Technology Co., Ltd. (搜索)
"This MOU represents our first Phase III international CDMO project, a strong vote of confidence in our Zhubei smart GMP facility," stated Jiunn-Rong Chiou, Chairman of Locus Cell (搜索). "It proves our vision of 'rooted in Taiwan, serving global clients' is achievable. By integrating FDA requirements—including electronic batch records, traceability, environmental monitoring, and data integrity—we are ready to seamlessly support global pharmaceutical partners."
Advanced Manufacturing Capabilities
The Zhubei Smart GMP Facility has been designed to meet both FDA and GMP standards, positioning it as one of the few facilities in Asia capable of handling both clinical and commercial production. Karolis Rosickas, CEO of Cambium Bio (搜索), highlighted the facility's capabilities: "Locus Cell (搜索)'s Zhubei smart GMP facility will meet FDA and GMP standards and is one of the few in Asia capable of both clinical and commercial production. Its digital-enabled stability and flexibility will lower costs, ensure quality, and strengthen competitiveness."
Global Expansion Strategy
The partnership forms part of a broader international expansion strategy for Cambium Bio (搜索)'s dry eye therapy. In addition to the manufacturing agreement with Locus Cell (搜索), Cambium recently signed a licensing MOU with France's Benta SAS (搜索) for Middle Eastern and European rights to Elate Ocular® (搜索). Outside of these regions, all other international clinical and commercial manufacturing will be handled by Locus Cell, accelerating global expansion and reinforcing the company's strategic role in the international supply chain.
Industry Significance
This collaboration marks a significant milestone for both companies, with Locus Cell (搜索) demonstrating its capabilities in advanced regenerative medicine and readiness to support large-scale clinical trials on a global scale. The agreement highlights the growing importance of specialized CDMO services in the regenerative medicine sector and Taiwan's emerging role as a manufacturing hub for international pharmaceutical companies.