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Download Cologne Facility At-a-Glance
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Cologne at-a-glance Our facility in Cologne, Germany, formerly NewLab BioQuality, offers comprehensive GLP-compliant services for virus and TSE validation studies of biopharmaceuticals. Background Service Areas/Study Types • Founded in 1994 as Analysis GmbH in Frankfurt, Germany • Virus and transmissible spongiform encephalopathy (TSE) safety process validation studies • Relocated to Cologne, Germany, in 2000 • Acquired by NewLab BioQuality in 2005 -- Selection of process steps • Acquired by Charles River in 2008 -- Verification of scaled-down process steps • New purpose-built facility opened in 2010 -- Selection of viruses (TSE spike) -- Performance of study Laboratories and Facilities • 1,474 square meters/15,866 square feet, including a 743-square-meter/7,997-square-foot laboratory • Biosafety Level 2 and Biosafety Level 3 laboratories • On-site IT support for client personnel • Extensive site security and confidentiality measures • Dedicated client labs and assigned guest offices • Good Laboratory Practice (GLP)-compliant archive • State-of-the-art, temperature-controlled laboratories -- Interpretation of results • Product experience -- Monoclonal antibodies -- Recombinant proteins -- Transgenic products -- Tissue-derived products -- Blood-derived products -- Medical devices Staff • 48 employees • 21% PhD, 17% MSc Cologne, Germany Cologne, Germany: 49 221 3461 800 • North America: 1.877.274.8371 [email protected] • www.criver.com © 2014, Charles River Laboratories International, Inc. Compliance, Certifications, Accreditations and Professional Affiliations • Code of Federal Regulations (CFR) 21 Part 58 • Directive 2004/9/EC • Directive 2004/10/EC • Organisation for Economic Co-operation and Development (OECD) GLP certificate • Excellent regulatory compliance history Regulatory Guidelines • Food and Drug Administration (FDA), USA • International Conference on Harmonisation (ICH) • Japanese Ministry of Health, Labour and Welfare (MHLW) • Korean Food and Drug Administration (KFDA) Quality and Process Initiatives • Lean Six Sigma program Cologne, Germany: 49 221 3461 800 • North America: 1.877.274.8371 [email protected] • www.criver.com © 2014, Charles River Laboratories International, Inc.
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