The A&M Group has been founded in 1990 and is dedicated to analytical services for pharmaceutical industry ever since.
We offer GLP and GCP compliant bioanalytical services for small and large molecules as well as biomarkers and new modalities like oligonucleotides. A dedicated team of 20 experts offers everything from method development, validation to the analysis of several hundred to thousands of samples. As profound experts in the field of drug metabolism, we also offer a variety of ADME services such as metabolic profiling and MetID.
Our GMP testing facility employs over 340 people dedicated to stability and release testing of small molecules and biomolecules, studies of primary packaging and single use materials (E/L-studies), as well as functional assays like ELISA and cell-based potency assays. The dedicated biopharma testing site in Bergheim (near Cologne) employs over 230 people. This site offers ICH-compliant storage of testing items, as well as testing of all relevant parameters for biopharmaceutical batch release or stability testing under one roof. There is no need for multiple site audits, all project experts are on one site and expensive and time-consuming sample shipment between testing sites is not required. For IgG-type biosimilars we offer a full range of generic stability indicating methods, which can be readily adapted to the formulation and validated for full GMP studies. This service can be offered within well-defined timelines at foreseeable costs. Projects with an international scope benefit from our outstanding FDA inspection track record with six consecutive inspections without observations.
Further information: www.am-labor.de