AZ Biopharm GmbH Berlin
Bioanalysis of human and veterinary pharmaceuticals – reliable and quick service
AZ-Biopharm is an independent analytical laboratory established under this brand name in 2002. We are working under GLP-GCP-GMP regulations with state-of-the-art equipment.
For pre-clinical, clinical human and veterinarian studies, a large pool of validated methods are available for the determination of APIs in plasma, whole blood, urine and in edible tissues and milk of farm animals.
Quantitative determination of analytes in plasma of farm animals and quantitative determination in medicated feed or milk replacers, also in the context of proof of stability, are likewise possible. All methods are validated according to relevant guidelines, e.g., EMA BMV, FDA the Guidance for Industry, white papers and EMA reflection papers. Analytical techniques available for the assays are HLPC with UV, FID, DAD, RI and electrochemical detection, LC/MS, LC/MS-MS, UHPLCMS- MS, ICP-MS, GC/ MS and ELISA.
We have all the measures in place to provide turnover times for QA-ed pharmacokinetic results during FIH-studies within 2 WD and 5 WD from last sample measured until QC-ed data within BE studies. For all studies we guarantee: 10 WD after data accepted by the sponsor until drafting the analytical report. Quality is always ensured by a constantly developed QC system and in close collaboration with sponsors and local authorities.
Annual sample throughput is +100.000 study samples. All samples are stored in large walk-in freezers at -20°C and or in mobile -70°C freezers which are constantly monitored.