XstalBio Issued US Patent for Stabilization of Therapeutic Proteins

XstalBio Ltd a biologic formulation and drug delivery company recently announced the United States Patent and Trademark Office has issued US Patent, US 8,932,715, covering the use of precipitation stabilizing 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.

“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,” said XstalBio R&D Director Barry D. Moore. “Compared to lyophilization 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 7 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.”

XstalBio is a privately held company founded in 2004 and based in Glasgow, Scotland. XstalBio works collaboratively with international clients to help drive biopharmaceuticals and vaccines to market by enabling delivery of products to patients. The company provides its experience, innovative technologies, and expert consultancy to find efficient solutions to complex bioformulation challenges and accelerate the development of biologics.

XstalBio has successfully formulated over 50 APIs working with many of the world’s top pharmaceutical and biotechnology companies as well as leading vaccine and animal health companies. APIs include mAbs, mAb fragments, cytokines, hormones, plasmids, and peptides spanning a broad range of molecular weights and physical characteristics. In addition, the company has generated novel adjuvant formulations of many types of antigens, including recombinant proteins, bacterial lysates, toxoids, and polysaccharides. Its scientists routinely take on challenging formulation issues and seek to solve them by applying innovative, straightforward, and scalable formulation technologies. The company has an excellent track-record for meeting milestones and moving forward with clients as their biopharmaceutical product challenges progress or change. To discuss or license any of XstalBio’s proprietary technologies for formulation, stabilization, delivery, or reconstitution of biologics, please contact them at m.c.parker@xstalbio.com, visit www.xstalbio.com, or talk to one of the XstalBio team by calling +44 141 330 3801.