Development and validation of a HPLC method simultaneously assisted with diode array and evaporative light scattering detection for the quantification of clinical mAb infusion bags in hospital pharmacy

Abstract

To secure the supply chain of the monoclonal antibody (mAb) standardized infusion bags, a reversed phase (RP) HPLC analytical method assisted with a diode array detector (DAD) and an evaporative light scattering detector (ELSD) was implemented in the pharmacy department of the university hospital center of Besançon (UHCB). For a well-defined batch, the concordance between the two detections evaluated using the Lin’s concordance correlation coefficient (CCC) (Lin’s CCC = 0.9858) and a Bland–Altman plot was excellent. The analytical quantification of the different dose-banded (DB) of the infusion bags prepared in advance were achieved using this new reversed HPLC-DAD/ELSD analytical method in less than 4 min. For a same batch of mAbs, DAD generated nearly uniform response and showed a slightly superior accuracy than did ELSD. Their agreement in terms of calculated dose is excellent. In the event of a breakdown of one of the two detectors, this allowed the mAb infusion bags to continue to be monitored and thus improved the drug supply chain safety. As well our optimized method was able to monitor degradation mAbs created by accidental stress during the time period of stockage.

Graphical Abstract

Keywords:

• DAD
• ELSD
• HPLC analysis
• monoclonal antibody

Acknowledgments

The authors would like to thank Gwenaelle Lenancker, Tiphaine Cholley, Théo Rousselle for their help in performing some experiments.

Ethics approval statement

Not applicable.

Contributor ship statement

YCG and CA conceptualized this work, designed the experiments, and wrote the manuscript. CA, CFL and YCG read the manuscript. All authors approved the final version of the manuscript for submission.

Disclosure statement

None declared.

Data availability statement

All relevant data are included in the manuscript.