Monoclonal Antibody (MAB) analytical control within a Centralized Chemotherapy Preparation Unit (CCPU): a 9 months activity report

M. Leroy, H. Laouar, D. Morel, S. Edet, A. Sarrazin, M. Rigal, A. Jacolot, C. Padoin Unité de Préparation et de Contrôle des Chimiothérapies anticancéreuses
PUI Avicenne
HUPSSD, AP-HP, Bobigny.

Introduction

The installation of the CCPU and, next to it, the laboratory control, took place at the same time. Our wish was to establish a qualitative and quantitative control before any dispensation of chemotherapies, including MAB. For that purpose, we choose QCPREP+. This is an UV-visible absorption spectrometry coupled with a Raman emission spectrometry, which is mostly used to identify complex drugs like MAB, while UV-visible spectroscopy is not specific enough.
This study is about the operating report of the MAB analytic control.

Materials and Methods

We doped with new calibration ranges the QCPREP+ research libraries used for the identification of both drugs and solvents. At the present day, 48 cytotoxics and 9 MABs are commonly identified and quantified. Here are the MABs control results reached from 09/01/2013 to 05/23/2014: control number N, conformity rate (%), non-conformity classification (NC class: Identification or Quantification), range area (mg.L-1), determination factor r2.

Results

The analytical control results of MABs in a sufficient number are introduced:

We did not have enough data for the Alemtuzumab, Ipilimumab, Ofatumumab and Pertuzumab to be presented.

Discussion-conclusion

The analytical control before dispensation is making workable with the carried method of QCPREP+. The NC rate of MABs control is about 2.3%, which is quite similar to the cytotoxic’s. The majority of NC is quantification errors.

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