Global nanotechnology company pSivida Limited has announced that it's UK manufacturing partner, Atomising Systems Ltd ("ASL"), has reached a key milestone in the manufacture of BrachySil, its lead product, by completing construction of a state of the art dedicated cleanroom facility to GMP specifications at its Sheffield plant in the United Kingdom. ASL is a world leader in high temperature atomising technology.
The milestone achievement will enable pSivida to increase BrachySil production in support of both larger clinical trials for advanced liver cancer and new Phase IIa trials in a second cancer indication planned for later this year. For future commercialisation, pSivida will use the dedicated facility to produce ultra-pure nano-structured BioSilicon microparticles doped with phosphorus: These microparticles are created using a specially developed melting process and water atomisation.
Following this process, the BioSilicon microparticles are activated to become BrachySil, i.e. the integral phosphorus is converted into its radioisotope form - 32-P - at AEA Technology QSA's Auriga Medical facility in Germany.
pSivida's Managing Director, Gavin Rezos, said, "The development of this facility is important in the future development of BrachySil as a solid tumor cancer therapy. It forms one piece of the overall process for getting this exciting product through clinical trials to market and scale up production once regulatory approval is received."
BrachySil has recently shown excellent results in Phase II clinical trials as a radiotherapy for the treatment of inoperable primary liver cancer, where it is delivered directly into tumors without surgery, a procedure known as brachytherapy.