Facing the Noncompliance Challenge
Therapeutics which require protracted and often painful intravenous administration can result in medication noncompliance by patients. When the drug delivery experience is unpleasant, avoidance is common, especially among patients with chronic disease.
In response to this challenge, biopharmaceutical companies strive to develop antibodies and other protein formulations containing high concentrations of therapeutics so that a single, small intramuscular or subcutaneous injection is efficacious.
However, high antibody concentration pushes the molecules closer together causing molecular crowding. In turn, crowding increases the propensity for protein-protein interactions that can disrupt the hydrogen bonding matrix, induce protein misfolding, and can eventually manifest as antibody aggregation.
When developing high concentrations of antibodies, it is essential to pinpoint the interfacial domains of protein interaction by conducting protein aggregation studies. By understanding antibody Higher Order Structure (HOS), the antibody formulation can be optimized to limit aggregation.