BIOANALYTICS USING CHROMATOGRAPHIC METHODS
In addition to pharmaceutical analytics, bioanalytics is the focus of our activities at AZ Biopharm. We analyze new and off-patent active ingredients of chemical origin as well as their metabolites, if required, biomarkers, oligosaccharides, and polypeptides using highly sensitive techniques such as
BIOANALYSIS BY IMMUNOLOGICAL METHODS
For monoclonal antibodies, biosimilars and other proteins used as drugs, we analyze pharmcokinetic (PK) samples, immunological (ADA and nAB) samples by means of
- immuno-linkage assays (ELISA).
For this purpose, the substances to be analyzed are extracted and analyzed from plasma, serum, whole blood, urine and tissue samples, which originate from both preclinical and clinical trials, according to GLP and GCP or also with “fit-for-purpose qualified” methods. For analytical performance we have staff with a total of more than 50 years of professional experience in bioanalytics and more than 300 validated assays at our disposal.
BIOANALYTICS BERLIN – AZ BIOPHARM
AZ Biopharm GmbH is constantly expanding its assay portfolio and annually develops and validates approximately 30 new methods for active pharmaceutical ingredients, their metabolites, biomarkers, oligonucleotides, polypeptides, monoclonal antibodies, biosimilars and pharmaceutical proteins. These methods are subsequently used in the routine analysis of study samples according to EMA, FDA and the ICH M10 guideline as well as the corresponding “white papers” in the context of
- pharmacokinetic studies (PK),
- bioequivalence studies (BE),
- bioavailability studies, each under GCP, and
- toxicokinetic testing under GLP.
The compliance of the bioanalytics with the applicable regulations is ensured by the consistent application of the guidelines as well as the membership and participation in the European Bioanalysis Forum (EBF). AZ-Biopharm is also a member of the German Quality Management Association (GQMA) and thus has an overview of current regulatory developments. This ensures that bioanalytics are carried out in accordance with current regulatory requirements.
Another field of activity includes the analysis of preclinical formulation samples as well as residue analysis from primary products of farm animals.