ITC
Drug Discovery & Development
Downstream Purification Development
Downstream bioprocessing 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 failures could have significant economic consequences. Screening candidates for manufacturability early in development is one of the ways to ensure that a protein will have the greatest chance of being successfully produced as a therapeutic enters late stage development. Also, the choice of the right purification conditions, including which chromatographic method to use during purification, and the selection of appropriate storage conditions for hold steps and for long-term storage are 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 bioprocessing conditions before running any downstream process. Differential Scanning Calorimetry (DSC) can provide this critical information and rapidly determine optimal bioprocessing conditions, thereby resulting in significant savings and improved shelf life.
Why use DSC during downstream 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.
- 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.
- Guide the selection of chromatographic methods before carrying out purification.
Purification processes can also affect biological activity. Various analytical methods are commonly employed to monitor the biological activity of monoclonal antibodies, antibody-like proteins and other biotherapeutics as well as vaccines during the development process to confirm that the molecules remain functionally active throughout development. Isothermal Titration Calorimetry (ITC) provides a rapid and easy way to monitor the biological activity of a biotherapeutic during purification development. Using ITC, biological activity is monitored in solution, label-free, requiring no immobilization and minimal assay development, thus providing unique benefits over other methods.
Why use ITC to monitor biological activity?
- All measures are done in solution, label-free, requiring no immobilization and minimal assay development.
- Monitor both binding affinity and stoichiometry in a single experiment.
- Quickly and easily assess whether a biotherapeutic remains functionally active during bioprocessing.
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