XstalBio Ltd has announced the United States Patent and Trademark Office has issued US Patent, US 8,932,715, covering the use of precipitation stabilising additives for manufacture of dry powders of therapeutic proteins, including monoclonal antibodies (mAbs).
Applications in development include proven multi-year intermediate storage of protein drugs as bulk dry powders (API stable for >7 years) and production of high concentration mAb solutions suitable for subcutaneous injection.
The proprietary technology allows delicate protein drugs, unstable in aqueous solution, to be rapidly and cost-effectively precipitated into very stable dry microparticles with full retention of bioactivity.
XstalBio has exclusive rights to the patented technology and is developing a commercial process suitable for GMP manufacture of tonne per annum quantities of protein powder.
XstalBio R&D Director, Barry D. Moore, commented “The stabilizing additives described in this patent have enabled XstalBio to develop an exciting platform technology for processing delicate therapeutic proteins into dry powders with exceptional shelf-lives. Compared to lyophilisation the XstalBio precipitation process offers advantages of speed, cost and dose-flexibility and it produces humidity- and temperature-stable powders that are much easier to handle than spray dried particles. Drug substance can be stored as a bulk dry powder without freezing for over seven years and the same platform formulation has been applied to multiple human and animal health proteins. We anticipate in the future this disruptive technology will provide significant benefits to patients, by helping pharma companies to bring a new generation of more convenient protein medicines to the market faster and at significantly lower cost.”