Subcutaneous delivery of protein therapeutics

Since their discovery monoclonal antibodies have been a worldwide medical phenomenon that has documented numerous novel therapeutic uses. However, delivery of such large therapeutic proteins remains a challenge in maintaining efficacious systemic concentrations as well as minimal costs. Furthermore, pharmacokinetic profiles of monoclonal antibodies begin to vary from the norm when considering obese populations and require additional analysis to avoid over-dosing. The goals of this thesis work were: 1) to develop a generic bioanalytical method for quantifying concentrations of multiple monoclonal antibodies without requiring the use of specific coating antibodies for each separate monoclonal antibody evaluated; 2) to evaluate the pharmacokinetics of rituximab in obese rats and normal-weight control animals; 3) to develop an in-vitro cell culture permeability assay for evaluating permeability properties of monoclonal antibodies.M.S.Includes bibliographical referencesby Andrew Maurice She