Drug Discovery & Development

Application Notes

Presentations

Optimization of Purification Conditions

A downstream production process must achieve the required purity and yield at a given scale and within a given economic framework.  Scalability, batch-to-batch reproducibility and yield are always of great concern since batch failure could have major economic consequences.  Thus, the choice of the right purification conditions is critical as these not only affect time to market, but also product yield and ultimately profitability. Now you can discover whether a biotherapeutic is stable under selected chromatographic loading and eluting conditions before running any purification process.  Differential Scanning Calorimetry (DSC) can provide this critical information and rapidly determine optimal purification conditions, thereby resulting in significant savings.

DSC can identify the most stabilizing loading and elution conditions before running any purification procedure(s). In the example shown above, the DSC data set was used to identify the most stabilizing elution conditions for a monoclonal antibody. Under the identified stabilizing conditions, the loading capacity of the column was increased resulting in significant financial savings during GMP runs (Data and image courtesy of Prathima Archarya, Diosynth Biotechnologies).

Why use DSC during biopharmaceutical process development?

• Rapidly, in days compared to weeks, optimize loading and elution conditions throughout purification.                    
• Increase the efficiency and yield of biotherapeutic purification, resulting in substantial financial savings.

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