Antibodies tend to aggregate at the high concentrations typically required for their therapeutic application. The key challenge of this study was to reduce the rate of aggregation in isotonic aqueous formulation of rituximab at 100 mg/ml, whilst maintaining the pH of the original product to minimise the risk of increased rate of chemical instability
Rituximab, currently a liquid product, was reformulated into an aqueous presentation at 100 mg/ml based on the ArestatT formulation tools. The control was based on a marketed formulation, working at the same concentration. Improved formulations of rituximab were achieved by application of a recently discovered variant of ArestatT technology, namely Arestat-CT. Using the principles of the Arestat-CT formulation tools, rituximab formulated at 100 mg/ml and placed on storage trial for 12 weeks at 40?C had considerably lower rates of aggregation (formation of high molecular weight species - HMWS, measured by size-exclusion chromatography) compared with that of the control
