(openPR) - Freiburg, 13. August 2008 - M-Scan GmbH (Freiburg, Germany) now provides GMP compliant contract analysis and has notified the Regierungspäsidium Tübingen according to article § 67 Arzneimittelgesetz (AMG).
After only 18 months since becoming operational, M-Scan GmbH has joined the other M-Scan labs in the UK, Switzerland and US, in offering a range of protein and glycoprotein analytical services in compliance with GMP regulations. “The quality system established at M-Scan GmbH has already been proven for many years at the other M-Scan laboratories. Also, M-Scan’s experience with MHRA, FDA and Swissmedic audits has contributed to a smooth and fast implementation of the quality system at M-Scan GmbH” stated Dr. Matthias Berg, Laboratory Manager of the 400sqm laboratory in Freiburg.
The M-Scan site in Freiburg specialises in analysis of biopharmaceutical products, from peptides and proteins, to biosimilars, engineered glycoproteins and monoclonal antibodies. This includes impurity analysis, amino acid analysis, extinction-coefficient estimation and determination, N- and C-terminal sequencing, de-novo sequence determination and carbohydrate analysis to FDA, EMEA and ICH guidelines.
Please contact:
Dr. Pascale Seiter
M-Scan - Mass Spectrometry Consultants and Analysts
Office Bonn
Trierer Straße 72
D-53115 Bonn
Tel.: +49-228-8509145
Fax: +49-228-8509143
Email: services.de@m-scan.com
Web: www.m-scan.com
Dr. Jörg Müller, MBA
M-Scan - Mass Spectrometry Consultants and Analysts
Office Munich
Hauptstr.68
D-82008 Unterhaching
Tel.: +49-89 - 66 50 84 52
Fax: +49-89 - 66 50 84 54
Email: services.de@m-scan.com
Web: www.m-scan.com
About M-Scan
M-Scan provides specialist mass spectrometry and related services for the characterisation of pharmaceuticals and biotech products. Studies involve recombinant and native molecules at all stages of the product development pipeline, including research (Proteomics), process QC, bioanalysis and regulatory approval. Structural analysis services are tailored to the requirements of the FDA “well-characterized” or “specified” molecule definition and a full analysis package is provided for characterisation under the ICH Q6B guidelines.
The four laboratories in the M-Scan Group (UK, Switzerland, Germany, and US) are equipped with over 25 mass spectrometers, providing a range of ionisation and detection techniques for optimum sensitivity and versatility. The labs are supported by offices in Europe, S. Korea, Singapore and India.
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