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Eef H. C. Dirksen

Byondis - Analytical Development and Quality Control

SCHOLARLY PAPERS

3

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115

TOTAL CITATIONS

2

Scholarly Papers (3)

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1.

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
Downloads 64 (924,743)
Citation 2

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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

2.

An Inert Tracer for Protein a Chromatography: A Minimally Fluorescently Labeled Antibody

Number of pages: 12 Posted: 13 Jan 2024
Alois Jungbauer, Narges Lali, Liana Tsiatsiani, Walter Elffrink, Bas Kokke, Peter Satzer, Eef H. C. Dirksen and Michel Eppink
affiliation not provided to SSRN, Austrian Centre of Industrial Biotechnology, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Austrian Centre of Industrial Biotechnology, Byondis - Analytical Development and Quality Control and affiliation not provided to SSRN
Downloads 35 (1,263,436)

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Fluorescent dye, residence time distribution, Antibody, labeling, mass spectrometry

3.

An Inert Tracer: The Binding Site of a Fluorescent Dye on the Antibody and its Effects on Protein a Chromatography

Number of pages: 12 Posted: 29 Mar 2024
Narges Lali, Liana Tsiatsiani, Walter Elffrink, Bas Kokke, Peter Satzer, Eef H. C. Dirksen, Michel Eppink and Alois Jungbauer
Austrian Centre of Industrial Biotechnology, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Austrian Centre of Industrial Biotechnology, Byondis - Analytical Development and Quality Control, affiliation not provided to SSRN and affiliation not provided to SSRN
Downloads 16 (1,491,251)

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Fluorescent dye, residence time distribution, Antibody, labeling, mass spectrometry