Drug Discovery & Development

Application Notes

Presentations

Manufacturability and In-process Storage and Handling

Many proteins have a propensity to slowly aggregate and precipitate with time during storage or processing.  During the earliest phases of protein therapeutic development, one must often choose from multiple candidates. This provides an opportunity to go forward with the protein analog that is the most stable to a process and identify ideal storage conditions. Screening candidates for manufacturability is one of the ways to ensure that the protein will have the greatest chance of being successfully produced as a therapeutic enters late stage development.  Differential Scanning Calorimetry (DSC) can be used to discern manufacturability potential among different biotherapeutic candidates based upon thermal stability and solubility.  DSC can also be used to aid in the selection of appropriate storage conditions during hold steps in process development and long-term storage.

DSC can identify the most stable candidate for manufacturing based on thermal stability and solubility. (Data and images courtesy of Jie Wen, Amgen, Inc.)

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

• Easily determine guidance for optimal in-process storage and handling conditions before making critical decisions.
• Easily assess which candidate will be more easily manufactured before further critical development decisions are made.

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