In 1990 two scientists with a strong background in the field of pharmaceutical research and production founded the A&M Group. Since then this contract research organisation has constantly grown and today employs over 100 staff. These employees are spread over three strategic locations in Bergheim (near Cologne), Mainz and Basel. Being one of the first GLP certified contract research laboratories in Germany, the A&M Group has ever since gained well over a century of experience in GLP and cGMP compliant analytical services. This experience has been acknowledged by several positively commented FDA system audits.
Our comprehensive method portfolio can be subdivided into four fields of competence: bioanalysis (GLP), pharmaceutical analysis (GMP), mass spectrometry (GLP/GMP), and ICH compliant storage of pharmaceutical products.
Our bioanalysis core facility offers comprehensive analytical solutions surrounding the pre-clinical environment with special emphasis on pharmacokinetic and toxic kinetic studies in urine, plasma and tissues.
Off course, this service includes full method development and validation. Our experience in the field of stability testing (ICH Q1 A & ICH Q5) and its underlying analytic methods, e.g., detection of leachables and extractables from primary packaging, interactions of active substances with exciepence and identification of degradation products with regard to ICH 3Q A and ICH 3Q B guidelines, makes us an reliable partner of internationally renown pharmaceutical companies.
Mass spectrometry and its technical applications have been at the centre of the attention of the A&M Group ever since it’s founding days. We capitalise on this wealth of knowledge when characterising biopharmaceuticals (monoclonal antibodies & proteins) according to ICH Q6 B guidelines. Up to now we have characterised in excess of 50 biopharmaceuticals one of those even being Europe’s first approved “Biosimilar”.
The storage core facility of the A&M Group belongs to one of Germany’s largest storage units and has enough capacity to facilitate all samples needed for all kinds of stability studies at ICH compliant climatic conditions. Exceptional is our capability to even store drug substances and products which fall under the narcotics act. Further more, the storage facility coordinates the shipment of samples from the customer site to our laboratories and vice versa. Together with our long standing logistic partner we can guarantee a fully traceable shipment of samples.