Drug Discovery & Development

Assessing Biological Activity During Manufacturing

Antibodies, antibody-like proteins, and other biotherapeutics represent a large and growing number of molecular entities entering human clinical trials in virtually all disease indications.  Manufacturing processes can not affect biotherapeutic stability, but also biological activity.  Different analytical methods are employed to monitor the biological activity of biotherapeutics in manufacturing to confirm that proteins remain functionally active until patient delivery.

Isothermal Titration Calorimetry (ITC) provides a rapid and easy way to monitor the biological activity of a biotherapeutic during manufacturing.  Activity is assayed by monitoring both the binding of purified proteins to their therapeutic targets and the binding stoichiometry to ensure that a biotherapeutic retains functional activity.  Using ITC, biological activity is monitored in solution, label-free, requiring no immobilization and minimal assay development, thus providing unique benefits over traditional methods.

ITC quickly and easily assess whether a biotherapeutic remains functionally active during bioprocessing. Unlike “affinity-only” methods, loss of activity can be easily monitored by following the stoichiometry. Biological activity is monitored in solution, label-free, requiring no immobilization and minimal assay development, thus providing unique benefits over traditional 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 manufacturing.

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