XstalBio awarded US patent for stabilisation of therapeutic proteins
The company has developed a platform technology for processing delicate therapeutic proteins into dry powders with exceptional shelf-lives
XstalBio, a biologic formulation and drug-delivery company, has announced that the United States Patent and Trademark Office has issued US Patent, US 8,932,715, covering the use of precipitation stabilising additives for the 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.
Glasgow, UK-based 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 Moore, said the stabilising additives described in this patent have enabled the company to develop an innovative platform technology for processing delicate therapeutic proteins into dry powders with exceptional shelf-lives.
Compared with lyophilisation, Moore says 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 for more than seven years as a bulk dry powder without freezing and the same platform formulation has been applied to multiple human and animal health proteins.
'We anticipate in the future that 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,' he added.
