XstalBio Ltd: US Patent Issued for Stabilization of Therapeutic Proteins
XstalBio Ltd 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.
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