R&D Scientist Waters | TA Instruments Lindon, Utah
Thermal stability is a leading indicator of overall clinical success of biologic drug products, and DSC (differential scanning calorimetry) is a primary tool used to characterize the effect of the solution environment on protein stability. The TA Instruments RS-DSC (Rapid Screening-Differential Scanning Calorimeter) is geared towards the biopharmaceutical industry with low volume, high concentration samples and offers a new dimension in DSC technology by employing simultaneous sample measurements to allow for significantly improved throughput over traditional microcalorimetric methods. This presentation illustrates the applications of short-term thermal stability for screening of buffers and protein sequence modifications in antibody drug product development. New data on high concentration protein samples demonstrates concentration dependence on thermal stability resulting from changes in the solution environment differentially affecting stability as protein concentration increases. To rapidly uncover the effects of concentration dependence, the TA Instruments RS-DSC allows for direct analysis of formulation strength biologic drug products.
Learning Objectives:
Upon completion, participants will be able to describe the need for thermal stability screening of biologic drug products at formulation concentrations.
Upon completion, participants will understand the applications of the new technology in their workflow.
Upon completion, participants will be able to define the importance of differential scanning calorimetery in understanding the short term thermal stability of their drug products.
