(483) SCISSOR for in vitro evaluation and modeling of high concentration mAb formulation SC absorption
Introduction: The Subcutaneous Injection Site Simulator (SCISSOR) is used to simulate SC absorption of biologics. A trend toward high dose SC delivery of mAbs has necessitated understanding absorption behavior of formulations early during candidate screening. We present an evaluation of dissolution profiles for a set of high concentration mAb formulations (>150 mg/ml) with varying physicochemical properties. We used a Physics-hybrid neural network model to determine how mAb formulation and biophysical properties influence the Hill Equation coefficients and may allow prediction of dissolution kinetics.
Learning Objectives:
Understand how SCISSOR can be useful as a screening tool for high concentration SC mAb formulations
Explain the importance of formulation and biophysical parameters toward mAb behavior in the SC space
Demonstrate how modelling can elucidate the dissolution process of mAbs
