AZ Biopharm GmbH Berlin
Bioanalysis of human and veterinary pharmaceuticals – reliable and quick service.
AZ-Biopharm is an independent analytical laboratory, working under GLP-GCP-GMP requirements since 2002. We offer bioanalytic of small and large molecules within pre-clinical, clinical and veterinarian studies using >300 validated assays.
AZB also provides customized analytical solutions and develops/validates new methods for your drug candidates in whole blood, plasma, urine and/or tissue according to current guidelines especially ICH M10 using ELISA or UHPLCMSMS instruments. Our service portfolio is rounded off by our own lab kits production, sample logistic service as well as biostatistics.
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. 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 or in mobile -70°C freezers which are constantly temperature monitored.
Within our GMP department, we analyze raw material, excipients and FDP using state of the art equipment like HPLCDAD/ FLD/RID, GC-MS/MS and ICP-MS. AZB also carries out stability studies for FDP and IMP and has the permission to handle highly potent drugs and narcotics. Additional QP service for your FDP or IMP is possible at AZB as well.