M
Monica Sadek
Researcher at Genentech
Publications - 3
Citations - 18
Monica Sadek is an academic researcher from Genentech. The author has contributed to research in topics: Chemistry & Quality (philosophy). The author has co-authored 1 publications.
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Journal ArticleDOI
Multi-attribute method performance profile for quality control of monoclonal antibody therapeutics.
Zhiqi Hao,Benjamin Moore,Chengfeng Ren,Monica Sadek,Frank Macchi,Lindsay Yang,Jack Harris,Laura Yee,Emily Liu,Vanessa Tran,Milady R. Niñonuevo,Chen Yan,Christopher Yu +12 more
TL;DR: In this article, a multi-attribute method (MAM) using peptide map analysis with high resolution mass spectrometry is used for product characterization and the identification of critical quality attributes (CQAs) of biotherapeutic proteins.
Journal ArticleDOI
A Robust Purity Method for Biotherapeutics Using New Peak Detection in an LC-MS-Based Multi-Attribute Method.
Monica Sadek,Benjamin Nathan Moore,Christopher Yu,Nicholas Ruppe,Austin Abdun-Nabi,Zhiqi Hao,Melissa Alvarez,Sanket N. Dahotre,Galahad Deperalta +8 more
TL;DR: In this paper , a new peak detection (NPD) method is proposed for sensitive and unbiased detection of new or changing site-specific attributes between a sample and reference that is not possible with conventional UV or fluorescence detection-based methods.
Journal ArticleDOI
Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control.
Feng Yang,Jennifer Hongyang Zhang,Monica Sadek,Zhiqi Hao,Dietmar Reusch,Wayman Chan,Anja Bathke,Hilary Pallat,Victor F. Lundin,J. Felix Kepert,Patrick Bulau,Galahad Deperalta,Christopher Yu,Tura C. Camilli,Reed J. Harris,John T. Stults +15 more
TL;DR: The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry as discussed by the authors .