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.

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