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

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.