(21a) Injectable Hydrogel Beads for Delivery of High Concentration Mab Formulations

Monoclonal antibody (mAb) based therapeutics are now the largest and fastest growing sector of the biopharmaceutical market. These products have shown excellent results in clinical settings as a result of the high binding specificity and minimal side effects of mAbs. However, our inability to predict protein-protein interactions poses a challenge to formulation efforts for these products. As an example, several recent studies have demonstrated that concentrated mAb formulations necessary for subcutaneous (SC) injection are plagued by high viscosities that are detrimental to this form of drug delivery. To mitigate these hindrances, we have developed a hydrogel delivery vehicle for the encapsulation of mAbs at very high concentrations while maintaining formulations with low viscosity suitable for SC injection. Monoclonal antibody encapsulated beads are produced using a thermally responsive nanoemulsion that can be cross-linked by UV curing. The temperature dependence can be utilized to tune the internal structure of the hydrogel bead and subsequently, control the local concentration and release of mAb. Additionally, the concentrated local environment within the hydrogel matrix is expected to help not only to stabilize the protein for long-term storage and but also to retain its native structure and function upon release.