A&M STABTEST GmbH

Exhibitor

The A&M Group: Analytical Excellence Made in Germany

The A&M Group has been founded in 1990 and is dedicated to analytical services for pharmaceutical industry ever since.
We offer GCLP compliant quantitative and qualitative mass spectrometry services for samples from PK- and TK-studies, as well as the structural elucidation of unknown compounds in MetID projects. A dedicated team of 15 mass spectrometry experts offers everything from method development, validation to the analysis of several hundred to thousands of samples.
Our GMP testing facility employs over 250 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 150 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 time lines at foreseeable costs. Projects with an international scope benefit from our outstanding FDA inspection track record with six consecutive inspections without observations.
For more information on the services we supply, please contact Dr. Steven Watt (steven.watt@am-labor.de)



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There are two parts to the Festival of Biologics: four conferences covering Antibodies, Immunotherapy, Biosimilars and Clinical Trials and an exhibition featuring solutions for pharma and biotech.

There is a registration fee to attend the conferences. To visit the exhibition is free.