Analytical Center Biopharm GmbH is a FDA, GLP and GMP certified testing facility (CRO) with >20 years of experience in bioanalytical and pharmaceutical testing of human and veterinary drugs. We focus on the content of active substances and, where applicable, their metabolites in biological matrix (pharmacokinetic and bioavailability studies, residue analysis in edible farm animal tissues), stability testing and physicochemical analysis of intermediates according to the Chemicals Act of Germany.
We offer you:
• Tailored solutions and individual offers
• Qualified GLP and GMP-compliant analytics
• Competent and speedy advice and project processing
• Comprehensive reporting in German and / or English
• A high standard of quality, guaranteed by our independent quality assurance and constantly evolving
• Qualified / validated test equipment, which is subject to the continuous control of the QSE and meets the requirements of 21 CFR Part 11

Range of services:
• Method development and validation (also for highly active and toxic substances)
• Stability tests (storage for ICH conditions, also for BTM)
• Quality control of pharmaceutical raw materials, excipients and finished products according to Pharmacopoeia (PhEur, USP, JP etc) and according to customer methods
• Determination of the content of active pharmaceutical ingredients and their metabolites in biological matrix (including urine, plasma, serum, wound secretions)
• Residue analysis in tissues of farm animals and in milk
• Testing of intermediates according to chemical act (ChemGes)

The AZ Biopharm is distinguished in particular by
• Fast response times
o 15- 20 working days for the processing of orders for pharmaceutical analysis
o 5 working days from last sample measured in bioanalytics to the delivery of QA-th results
o 10 working days from the provision of the final results in bioanalytics to the provision of the draft report
Special experience
• More than 400 BE studies with a positive authority vote with regard to bioanalytics
• Carrying out numerous release studies
Capacity
• Over 75,000 study samples per year in bioanalytics
• Test of 200 finished drug product batches per month
• Climate chambers according to ICH conditions
• Walk-in freezer at -20 ° C for storage of bioanalytical samples
• Additional climate cabinets for other climates and freezers at -80 ° C