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Thomas Pohl

Novartis Institutes for Biomedical Research, Cambridge - Novartis Pharma AG

45 Sidney Street

2nd Floor

Cambridge, MA 02139

United States

  • Novartis Institutes for Biomedical Research, Cambridge - Novartis Pharma AG

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Compliance and Regulatory Considerations for the Implementation of the Multi-Attribute-Method by Mass Spectrometry in a Quality Control Laboratory

Number of pages: 30 Posted: 26 Jul 2023
Annick Gervais, Eef H. C. Dirksen, Thomas Pohl, Karoline Bechtold-Peters, Will Burkitt, Valerio D’Alessio, Simone Greven, Andrew Lennard, Xue Li, Christopher Lössner, Ben Niu, Dietmar Reusch, Tomás O’Riordan, Justin W. Shearer, David Spencer, Wei Xu and Linda Yi
UCB, Byondis - Analytical Development and Quality Control, Novartis Institutes for Biomedical Research, Cambridge - Novartis Pharma AG, Novartis Pharma AG, UCB - Biological Characterisation Product Development Sciences, Merck Serono S.p.A. - Analytical Development & Innovation NBE, Bayer AG, Amgen Ltd, Bristol Myers Squibb, SCM, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol Myers Squibb, Roche Diagnostics GmbH Penzberg, Eli Lilly Kinsale Limited, GSK, Ipsen Biopharm Limited - BioPharmaceutical Development, AstraZeneca Pharmaceuticals - BioPharmaceuticals R&D and Biogen
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liquid chromatography mass spectrometry, multi-attribute method, Quality control, analytical target profile, critical quality attributes, new peak detection, compliance, regulatory submission