In the field of bioanalysis we determine active substances in biological samples mainly derived from preclinical and clinical studies. We work according to the newest GLP and GCP guidelines.
Method Development and Validation
We develop methods for extraction and quantification of active substances in biological matrices. According to our customersâ€™ wishes, we also optimize pre-existing methods.
The validations of our methods are based upon the current EMA or FDA guidelines. These validations are normally conducted under GLP-conditions, however, upon special request of the client, another procedure can be Chosen.
Determination of Active Substances in Biological Matrices
The structure and physicochemical characteristics of the analyte to be examined, as well as the detection limit desired, guide the selection of instrumentation for the analysis.
Quantification of small molecules:
HPLC â€“ UV-Vis / ECD (electrochemical detection) / FD (fluorescence detection)
LC â€“ MS/MS with ESI (electrospray-ionisation) or APCI (atmospheric pressure chemical ionization) source options
Quantification of proteins /antibodies / antigens / ADA (anti-drug antibodies) / biomarkers / biosimilars:
ELISA â€“ absorption / fluorescence /luminescence
Determination of enzyme activity:
Microtiter Plates Reader â€“ absorption / fluorescence / luminescence
Evaluation and Reports
All data are evaluated and reported according to the newest guidelines (EMA or FDA).
In addition to generic data evaluation software, the following specialist software is available for specialist data processing:
Parallel Line Assay (PLA) Software 3.0 from Stegmann Systems: This software can be used to calculate the relative potency of a dilution assay and furthermore aids configuration optimization in identifying acceptable regions of the doseâ€“response curve.
PhoenixÂ® WinNonLin Software 6.4, from Pharsight Corporation:
Compartmental and non-compartmental pharmacokinetic evaluation as well as PK/PD modelling.