Ex vivo biologics characterization

Cases and White Papers

Using our core characterization method AF4, we probe protein therapeutic characteristics and behavior in plasma, serum and whole blood – thus providing a route to investigate parenteral drugs in its intended in vivo application in an effort to improve patient cohort selection. This in order to maximize the positive impact of the drug while mitigating possible adverse risks. Such extensive characterization cannot be done with any other method.

  • We characterize biologics in formulations as well as in complex ex vivo samples
  • We provide fast and inexpensive sample analysis that monitor the individual response to treatment
  • The method can be used from R&D through clinical studies to batch release on the market

IgG antibody in plasma

In our recent publication we labeled an IgG antibody with the fluorescent marker FITC and analyzed it in PBS and in plasma.

  • The fluorescence detector detects the labeled IgG (while UV/MALS/dRI detectors detect all components of the plasma)
  • Peak profile differences indicate interactions between plasma components and the FITC-labeled IgG
  • We regularly run customer projects using patient tissues

Blood samples under close to native conditions

The ability to analyze blood samples under close to native conditions (i.e., ionic strength, pH, no filtering, no centrifugation, no addition of organic modifiers/solvents, no detergents) opens the possibility for:

  • Blood protein size profiling – investigating differences in the size distribution of blood between samples and changes over time
  • Investigations of therapeutic proteins when in blood

The elution profiles of serum and plasma show peaks that correspond with serum albumin (at 5 min) and immunoglobulin G (at 7 min). The third peak in the plasma profile may be fibrinogen which is expected to be present in plasma but not in serum. The elution profile of whole blood shows a peak that coincides with IgG and also larger sized components – the largest few in number (can be entire blood cells or fragments of them).