Drug Discovery & Development

Application Note

Presentation

Assessing Biocomparability for Lot Release

A biotherapeutic must maintain stability throughout storage until delivery to a patient.  Many proteins have a propensity to slowly aggregate and precipitate with time during storage, thereby representing significant loss of profit.  Differential Scanning Calorimetry (DSC) enables the rapid, accurate, and easy to perform measurement of the thermal transition midpoint (T_m) which has proven to be an exceptionally good indicator of the relative stability of biotherapeutics in solution.  Biocomparability studies using DSC can quickly identify the stability of a drug product when compare to a standard, thus allowing delivery of drug product in its native state.  DSC can also be used to aid in the selection of the appropriate storage conditions for either in-process or long-term storage.

DSC can be used to predict biotherapeutic stability as well as if structural changes have occurred during storage. In the example above DSC data correlates well with the stability predictions made with SEC-HPLC; an industry standard in stability predictions (Data and images courtesy of Jie Wen, Amgen, Inc).

Why use DSC for the assessment of manufacturability and storage and handling conditions?

• Easily determine guidance for optimal storage conditions before making critical decisions
• Quickly and easily assess the biocomparability of a drug product before  shipment

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