Bristol-Myers Squibb: The Analyst’s Perspective – Assuring and Controlling Quality of Well-Characterized Biologics

Analytical methods are the foundation of all biopharmaceutical work: from product discovery, characterization, formulation, and testing to process development and optimization, raw materials analysis and equipment qualification, and quality assurance and control. Over the past 15 years, technological advancements have improved precision, robustness, reproducibility, linearity, and control over the vast array of assays and analytical instrumentation available for biochemical, microbiological, and cell biology studies. Single-use technologies have introduced organic chemistry and materials science into the mix. Authors, reader-survey respondents, and editorial advisors helped us identify and examine trends in comparability testing, multivariate analysis, automation, statistics, validation, and more.