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In this video an aqueous protein/parenteral excipient formulation is flow-precipitated at room temperature and pressure to form a suspension of dehydrated protein microparticles.  Even at this lab-scale, protein is processed at 5g per min and can then be secondary dried by vacuum or SCFE depending on the application. A GMP compliant process has been built and a manufacturing plant is being developed. XstalBio's flow-precipitation technology provides a versatile platform for processing therapeutic proteins and vaccines into extremely stable dry powders. Applications include inhalable biologic powders, concentration of therapeutic proteins, such as mAbs, to >150 mg/ml,  intermediate solid-state storage of sensitive proteins, such as ADC, sustained release formulations of proteins and cold-chain free oral vaccines.<br/><br/>These patented technologies are available for licensing from XstalBio. Please visit www.xstalbio.com or contact Dr. Marie Claire Parker by calling +44 141 330 3801. <br/>

Disruptive technologies for formulation, stabilisation and delivery of therapeutic proteins

XstalBio Ltd today announced the launch of CentuRecon™, a new patented reconstitution technology that has the potential to revolutionise the preparation of high concentration protein solutions from dry powders and make delivery faster and safer. Biologic drugs such as monoclonal antibodies are a major growth area for the pharmaceutical industry but their delivery by subcutaneous administration provides unique challenges.  CentuRecon™ enables dry formulations of therapeutic proteins to be prepared for injection at high concentration in minutes, rather than hours, and produces foam-free solutions that maximise the deliverable dose.  CentuRecon™ works well with standard lyophilised formulations and diluents and with normal vials, cartridges or dual-chamber syringes. It is particularly beneficial for very high concentration and/or viscous solutions that may need to be delivered with injection devices. Medical practitioners will find CentuRecon™ straightforward and cost-effective to implement with patients benefiting from fewer injections and shorter visits.  Further developments are expected to make self-administration simpler and more convenient. 

XstalBio’s R&amp;D Director, Barry D. Moore, commented “We believe CentuRecon™ is a game-changing technology; uniquely it provides a rapid, safe and reproducible method for preparing very high concentration protein solutions from dry powder formulations. We believe it will open up new clinical opportunities for biologics and become the reconstitution method of choice for R&amp;D scientists.   CentuRecon™ is a good example of how XstalBio’s R&amp;D team are able to develop technologies that provide simple solutions to complex problems.”

This patented technology is available for licensing from XstalBio. Please contact us at: centurecon@xstalbio.com, visit www.xstalbio.com or to talk to Dr. Marie Claire Parker by calling +44 141 330 3801. 

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