AZ Biopharm GmbH Berlin

AZ Biopharm GmbH is a GLP/GMP certified CRO with many years of experience in bioanalytical and pharmaceutical testing of human and veterinary drugs. Under GLP/GCP we determine drugs, metabolites, oligonucleotides, biomarkers, biosimilars and ADCs in biological matrix from BE-, PK-, TK- and BA- studies using state-of-the-art analytical techniques like LC-MSMS, GC-MSMS, ICP-MS and ELISA. Under GMP we are doing QC of APIs, drug products, IMPs and stability testing.

We offer
Tailored solutions and individual offers
Qualified GLP/GCP and GMP-compliant analytics
Competent and speedy advice and project processing
Comprehensive reporting in German and/or English
Qualified/validated test equipment acc. 21 CFR Part 11

Range of services
Bioanalytics from preclinical to PhiII and BE studies
Bioanalytics of small chemical and biological drugs
Biostatistics for preclinical tox and clinical studies
Preparation of clinical trial material and lab manuals, and sample logistics
Stability tests (storage under ICH conditions, also for controlled substances)
Quality control of pharmaceutical raw materials, excipients, finished products and IMPs according to Pharmacopoeia (Ph. Eur., USP, JP etc.) and according to customer methods

Our equipment
LC-MSMS from Sciex (API 4000 and 6500+),
GC-MS and GC-MSM from (Shimadzu)
ICP-MS from Thermo
14 modern automatic HPLC devices with various detectors
12 devices for testing in-vitro release
Storage at temperatures below freezing (- 20 °C, - 80°C)

The AZ Biopharm is distinguished in particular by
5 working days from last sample measured to the QAed results
10 working days from the provision of the final results to the draft report

Special experience
More than 200 BE studies, also with highly active compounds and BTMs

Capacity
Over 100,000 study samples per year in bioanalytics
Walk-in freezer at -20 °C

Quality
GLP certified since 2003, GMP certified since 2012, numerous successful company audits (last year 16)

Further information: www.az-biopharm.de