Beta Cyclodextrin Derivatives as Protein Aggregation Modulators

Protein aggregation is the major challenge encountered during manufacturing, storage and transportation of biopharmaceuticals (1,2). The objective was to evaluate the effect of two ßcyclodextrins derivatives: (KLEPTOSE® HPB hydroxypropyl-ß-cyclodextrin, with MS=0.65) and (KLEPTOSE® HP hydroxypropyl-ß-cyclodextrin, with MS=0.9) on two biologic drugs (Infliximab and Etanercept) aggregation using high-throughput formulation screening (iFormulate™) and nanoDSF (Differential Scanning Fluorimetry) (3,4).

Preliminary results demonstrate that KLEPTOSE® HPB BioPharma hydroxypropyl-ß-cyclodextrin and KLEPTOSE® HP BioPharma hydroxypropyl-ß-cyclodextrin at high molarity (200 mM) are efficient tools in modulating Infliximab relative degree of aggregation.