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Simplifying workflows for MAM-based critical quality attribute monitoring of biotherapeutics in process development and QC using a novel LCMS platform

 

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A WORKFLOW DRIVEN PLATFORM SOLUTION FOR MAM-BASED CRTICAL QUALITY ATTRIBUTE MONITORING OF BIOTHERAPEUTICS IN PROCESS DEVELOPMENT AND QC Nilini S Ranbaduge, Ying Qing, Min Du, Weibin Chen Waters Corporation, 34 Maple Street, Milford, MA 01757, USA INTRODUCTION Biotherapeutics undergo rigorous…
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[ APPLICATION NOTEBOOK ] Multi-Attribute Methods for Biopharmaceutical Analysis Application Notes [ APPLICATION NOTEBOOK ] Introduction The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years. The ability…
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Pushing the Edge… With All Deliberate Speed Joe Fredette Senior Marketing & Business Development Manager Biopharmaceuticals Business ©2018 Waters Corporation COMPANY CONFIDENTIAL 1 Presentation Outline  Biopharma Industry Perspective  How Waters is Responding  Our Goal of Harmonization …
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PEPTIDE CHARACTERIZATION AND MONITORING WORKFLOW FOR BIOSIMILAR mAb DRUG PRODUCTS USING A COMPLIANCE READY LC-MS AND INFORMATICS PLATFORM 20221115_Remicade T0_200ng_03 2 TOF MSe (50 2000) 6V ESI (BPI) 1/2 20221115_Inflectra T0_200ng_12 2 TOF MSe (50 2000) 6V ESI (BPI) Kellen…
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