Bioanalysis

AZ Biopharm is a GLP/GMP-certified test facility

Bioanalytics

In addition to the pharmaceutical analysis, bioanalytics is the other core activity at AZ Biopharm. We analyze new and as well patent-free drugs, and if necessary, also their metabolites, biomarkers, oligosaccharides and polypeptides using highly sensitive technology such as

  • UHPLC-MSMS
  • HPLC-MS / MS
  • GC-MS
  • Immuno-binding assays (ELISA).

For this purpose, the substances to be analyzed, are extracted from plasma, serum, whole blood, urine and tissue samples, which originate from both preclinical and clinical trials, according to GLP and GCP or using “fit-for-purpose” qualified methods and analyzed by means of above-mentioned technologies. For the method development, validation and study conduct, we have employees with a total of more than 50 years of professional experience in bioanalytics and more than 300 validated assays.

AZ Biopharm GmbH is constantly expanding its assay portfolio and annually develops and validates around 30 new methods for active pharmaceutical ingredients, their metabolites, biomarkers, oligonucleotides or polypeptides. These methods are then used in the routine analysis of study samples in accordance with the EMA and FDA guidelines and the corresponding “white papers” for

  • pharmacokinetic and pharmacodynamic studies,
  • bioequivalence studies,
  • bioavailability studies and
  • toxicokinetic studies.

The compliance of the bioanalytics with the applicable national and international regulations is ensured by the consistent application of the guidelines as well as membership and active participation in the European Bioanalysis Forum (EBF). The AZ-Biopharm is also a member of the German Quality Management Association (GQMA) and thus can track and apply current regulatory developments. Therefore, we can guarantee our clients that the bioanalytics is in fully compliance with the current regulatory requirements.

Another area of our activities in the GLP analytics includes the analysis of preclinical formulation samples as well as residue analysis from primary products of farm animals.