Cleanroom completed for cancer therapy

Published: 17-Oct-2005


Nanotechnology company pSivida's manufacturing partner QSA has completed the construction and validation of a state-of-the-art cleanroom facility at its Auriga Medical facility in Braunschweig, Germany, dedicated to the supply of pSivida's lead cancer therapy, BrachySil.

The cGMP facility will fulfil the final process in the manufacture of BrachySil for future clinical and commercial use, and represents the final stage in establishing the manufacturing and supply infrastructure to take it through clinical trials to market. pSivida and QSA entered into an extendible three-year manufacturing agreement for BrachySil in March 2004, under the terms of which QSA's specialist brachytherapy and radioimmunotherapy business, Auriga Medical, was to design and construct a dedicated facility, optimised for the processing of BrachySil. Auriga Medical will also manage the supply logistics for clinical and commercial use. "This facility marks a significant step forward towards commercialising BrachySil," said pSivida's managing director Gavin Rezos. "All key steps and facilities are now operating to the essential GMP requirements necessary for regulatory approval."

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