Development of a robust pH gradient method for monoclonal antibody charge variant analysis using cation exchange chromatography and a quality-by-design approach

Application note | 001631 Pharma Development of a robust LC method for metolazone and related impurities using analytical quality by design best practices Application benefits Authors Sylvia Grosse , Soo Hyun Park , 1 1 • Thermo Scientific™ Vanquish™ UHPLC…

Application note | 002598 Biopharma Automated method optimization for drug-to-antibody ratio determination using hydrophobic interaction chromatography Application benefits Authors Xuepu Li1, Xiaoxi Zhang1, Christof Mitterer2, • Robust and reproducible DAR determination methods for cysteine-linked ADCs, brentuximab vedotin, disitamab vedotin, and…

Automated QbD-Based Method Development and Validation of Oxidative Degraded Atorvastatin Application Note Pharmaceutical QA/QC Authors Abstract Vinayak AK and Syed Salman Lateef Quality-by-Design (QbD) approach emphasizes risk management and sound Agilent Technologies Inc, science. Its application in analytical method development…

[ APPLICATION NOTE ] Applying a Software-Assisted Analytical Quality-by-Design Approach for the Analysis of Formoterol, Budesonide, and Related Compounds by UPLC-MS Fadi L. Alkhateeb and Paul Rainville Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ ■■ ■■ INTRODUCTION Benefits…