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Uses of Differential Scanning Calorimetry within Biopharmaceutical Development

According to a recent survey run by the HOS (higher order structure) consortium, which asked its members which techniques were most used for various applications in the development of biotherapeutic drugs, Differential Scanning Calorimetry (DSC) was highlighted as a useful technique in a wide range of areas, from candidate validation through to biosimilarity studies. The technology was voted particularly beneficial during formulation development and for comparability and biosimilarity studies.  This was underlined recently when DSC was used in the successful submission to the EMA for approval of Celltrion’s Remsima, a biosimilar to Remicade for treatment of rheumatoid arthritis.

The World Health Organization (WHO) names DSC in its guidelines to assure the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology (Replacement of Annex 3 of WHO Technical Report Series, No. 814).  In addition, a recent paper and webinar by John Gabrielson of Elion Labs shows the value of using the technique of Differential Scanning Calorimetry (DSC) to characterize the conformational stability of biotherapeutic products.