French reference laboratory for the Therapeutic Drug Monitoring of monoclonal antibodies
The laboratory of Medical Biology of Tours University Hospital is labeled Reference Medical Biology Laboratory (Laboratoire de Biologie Médicale de Référence) for the Therapeutic Drug Monitoring (TDM) of monoclonal antibodies (2021-2026, decree published by the Ministry of Health in July 15, 2021). It is the only french laboratory with this title. A presentation and a directory of LBMRs (in French) is available on the website of French Ministry of Health.
Serum concentration of monoclonal antibodies varies from patient to patient, even when their dosage is adapted to weight. This is partly explained by the activity of the treated disease. In addition, there is a relationship between serum concentration of monoclonal antibodies and their efficacy and, in certain cases, between their serum concentration and their adverse effects.
The residual serum concentration of monoclonal antibodies, measured just before an injection, is therefore a biomarker of their efficacy and allows dosage personalization. This is the principle of therapeutic drug monitoring.
The medical biology analyses listed below are based on ELISA techniques developed and validated in the laboratory of Pharmacology-Toxicology of Tours University Hospital, with the help of the Pilot centre for Therapeutic Antibody Monitoring (PiTAM) (Centre Pilote de suivi Biologique des traitements par Anticorps, CePiBAc). These analyses are performed in the environment of the Laboratory of Medical Biology of Tours University Hospital, CHRU de Tours, which is accredited by COFRAC according to standard NF EN ISO 15189 (accreditation n° 9-3537. scope and sites available on www.cofrac.fr).
Antibodies or fusion proteins* whose serum concentrations are measured and interpreted:
adalimumab (Humira® and biosimilars) - Desvignes C et al. Bioanalysis 2015
basiliximab (Simulect®) - Thibault G et al. Transpl Int 2016
bevacizumab (Avastin® and biosimilars) - Ternant D et al. Ther Drug Monit 2010
cetuximab (Erbitux®) - Cézé N et al. Ther Drug Monit 2009
eculizumab (Soliris®) - Passot C et al. Bioanalysis 2017
infliximab (Remicade® and biosimilars) - Ternant D et al. Ther Drug Monit 2006
panitumumab (Vectibix®) - Desvignes C et al. Bioanalysis 2018
ramucirumab (Cyramza®) - Desvignes C et al. Bioanalysis 2021
rituximab (Mabthera® and biosimilars) - Daydé D et al. Blood 2009
trastuzumab (Herceptin® and biosimilars) - Bernadou G et al. Br J Clin Pharmacol 2016
Analyses in development:
(will soon be indicated)
If you need an analysis to be performed:
For a biomedical research project: Please go to the CePiBAc page (Centre Pilote de suivi Biologique des traitements par Anticorps - in French)
More information : Team - e-mails (in French)
Last update: May 25th, 2023