Sanquin improves accuracy for therapeutic drug monitoring of biologicals

For nearly 10 years, Sanquin has offered service testing for pharmacokinetics and immunogenicity of various biologicals, using in-house developed assays. These assays were used to generate significant insights into the clinical relevance of antibodies against biologicals (see publications).

In recent years, the application of diagnostics for biologicals has been shifting more and more from detection of unwanted immunogenicity towards monitoring of therapeutic drug levels, to ensure that every patient receives and adequate but not unnecessarily high drug dosage.

To support reliable drug monitoring, Sanquin has now further automated its drug level assays to increase precision and robustness using state-of-the-art equipment, and optimized its reference preparations for enhanced accuracy. Sanquin has implemented this new approach for the following biologicals: 

Adalimumab:                    January 2013
Infliximab:                        February 2013
Certolizumab-pegol        April 2013
Etanercept:                       May 2013
Rituximab:                        May 2013
Golimumab:                      June 2013
Tocilizumab                      September 2013
Abatacept                         October 2013
Ustekinumab                   December 2013

Results obtained using the old and new procedures correlate significantly, but the new procedures were found to result in improved accuracy. By implementing optimized procedures, Sanquin facilitates reliable therapeutic drug monitoring, both on the individual patient level as well as for large scale clinical studies.