Northwest Biotherapeutics has entered into agreements for large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax-L and DCVax-Direct products, with its long-time contract manufacturer, Cognate Bioservices. The agreement includes development of infrastructure and key systems, and execution of product validation work required for regulatory submissions.
Cognate will provide manufacturing and services for DCVax-L and DCVax-Direct. Additional agreements provide for a comprehensive scale-up program for expansion of the company's clinical programs in the U.S. and Europe, and compassionate use programs, as well as an extensive development program for long-term preparations for potential commercialization, including building the infrastructure, systems and logistics for product validations.
"We are excited to enter into a broad program to expand capacity and build large scale infrastructure, systems and operations under these Agreements with Cognate," said Les Goldman, senior vice president of business development at NW Bio. "Such a program is essential for our future success, and involves a major commitment of resources and time. Cognate is a world leader in such developments, with an unparalleled 12-year track record of regulatory and operational success with two dozen different cell product trials, and with clinical grade manufacturing of cell products on three continents. We could not have a better and more effective partner for this major undertaking."