Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations

Monoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer autoimmune disorders, but dosage forms typically limited to low concentrations large fluid volumes due formulation challenges. Hydrogel microsphere formulations offer a route quicker, patient-friendly dosing regimens monoclonal with loading favorable flow properties needed injection through narrow syringe needle under moderate applied force. Crystals an intact antibody prepared as concentrated suspension (>300 mg mL−1) which is then encapsulated within hydrogel microspheres diameters small 30 µm. The contain up 56 wt% (dry basis) release 4 days vitro dissolution conditions. into densely packed suspensions containing 300 mL−1 evaluate flow. These shear-thin have lower viscosity when compared both liquid suspended crystal antibody, demonstrating potential encapsulants carrier can mask undesirable therapeutics.