Meeting the Challenges of Implementing Accurate-Mass Mass Spectrometry for Biotherapeutic Development in Regulated/non-Regulated Environments

BIOPHARMACEUTICAL PLATFORM SOLUTION Key Applications TABLE OF CONTENTS Biopharmaceutical Platform Solution with UNIFI: Key Applications Intact Protein MS Analysis I Peptide Mapping I Released Glycan Analysis I Bioseparations Biotherapeutic proteins – such as monoclonal antibodies (mAbs), biosimilars, and antibody drug…

[APPLICATION NOTEBOOK] At-line Solutions for Upstream Bioprocessing Application Notes [APPLICATION NOTEBOOK] Introduction Bioprocessing harnesses the power of living cells to manufacture valuable products such as biological drugs for clinical use. The introduction and use of biologics has revolutionized biotherapeutics to…

SmartMS-ENABLED LC-MS SYSTEM FOR BIOTHERAPEUTIC DEVELOPMENT IN REGULATED/NON-REGULATED ENVIRONMENTS Henry Shion1; Mellisa Ly2; Nilini Ranbaduge1; Ximo Zhang1; Yun Alelyunas1; Ying Qing Yu1; Jason Rouse2; and Weibin Chen1 1 Waters Corporation, Milford, MA 01757; 2Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc., Andover, MA…

[ TECHNOLOGY BRIEF ] Analysis of Antibody Drug Conjugates (ADCs) by Native Mass Spectrometry on the BioAccord System Henry Shion, Ying Qing Yu, and Weibin Chen Waters Corporation, Milford, MA, USA Drug-to-Antibody Ratio (DAR) determination of Lys and Cys conjugated…