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.
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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.