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Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents.

Glenn T MillerTeresa M CaiazzoAlison Joyce
Published in: Journal of immunological methods (2024)
Stability of conjugated critical reagents supporting ligand binding assays to enable biotherapeutic drug development is a universal concern. Formulation buffer employed for long-term cold storage may be key to mitigate protein aggregation issues. We investigated biophysical and functional attributes of murine mAb and human multispecific drug labeled with biotin, ruthenium, and Alexa fluor 647 frozen at -80 °C in PBS or a protein storage buffer for 3-15 months. Aggregation was observed at 4 months in mAb A-Ru (11.2%) and -Alexa (10%) in PBS followed by precipitation and reduced biological binding at 15 months. Increased aggregation in drug Ru (11.7%, 6 months) and Alexa (6.9%, 15 months) were noted but without impact on performance. There were no observations with biotin labeled reagents.
Keyphrases
  • endothelial cells
  • drug delivery
  • photodynamic therapy
  • binding protein
  • pet imaging
  • high throughput
  • monoclonal antibody
  • computed tomography
  • high resolution
  • mass spectrometry
  • quantum dots