XstalBio tackles challenging biologic formulations (required dosing too frequent, controlled release of API required, competitors hold blocking formulation patents, better adjuvant needed for target antigens, etc… ).
XstalBio – bioformulation
XstalBio is driving biopharmaceuticals and vaccines to market by enabling delivery of products to patients. XstalBio provides experience, innovative technologies and expert consultancy to find efficient solutions to complex bioformulation challenges and accelerate the development of biologics. XstalBio has proprietary technology solving a wide range of bioformulation and delivery problems (delivery of high concentration protein solutions, dry biologic powders for delivery by inhalation, sustained release of biologics, thermally stable vaccines containing antigens, etc…). XstalBio has developed its proprietary protein-coated microcrystal (PCMC) technology to produce a respirable, stable pulmonary product. PCMC allows excellent powder handling characteristics and to easily control the API payload for both high and low potency requirements. XstalBio-PCMC particles are uniquely placed to deliver two or more biological actives, simultaneously immobilized in a chosen pre-set ratio on the surface of the particles. PCMC particles are straightforward to manufacture and have been scaled for production of clinical batches of product. XstalBio also developed CentuRecon, a novel method for rapid reconstitution of high concentration mAb or fusion proteins. This proprietary method 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 maximize the deliverable dose. CentuRecon is particularly beneficial for very high concentration or viscous solutions that may need to be delivered with injection devices. CaP-PCMC (calcium phosphate coated microcrystals) products can be prepared alternatively to supply as a ready-made and stable dry powder. XstalBio also offers XstalVax, providing a unique analytical service whereby vaccine antigens can be analyzed in situ, i.e. whilst bound to a particulate adjuvant, such as alum, Xstalbio’s proprietary vaccine formulations or immunostimulants such as CpG olidogdeoxynucleotides or MPL (Monophosphoryl lipid A). XstalVax can also provide troubleshooting investigations for formulated vaccines that are providing sub-optimal performance or are failing to deliver the required stability attributes.
XstalBio is a privately held formulation and drug delivery company with proprietary technologies applied to the delivery of biologics by injection, inhalation, oral and nasal routes. XstalBio is a biotech company based in Glasgow (UK) and Management Team is composed by Jan Vos, Allan Watkinson, Marie-Claire Parker, John Preston, Barry Moore and Frank Colhoun. XstalBio has successfully formulated over 40 APIs working with many of the world’s top pharmaceutical and biotech companies (including cytokines, mAb fragments, mAbs, hormones, plasmids, peptides, etc…).
More about XstalBio : www.xstalbio.com