Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

Introduction

• Capillary electrophoresis (CE) offers superior separation for complex biologics like monoclonal antibodies, but its irregular baselines and broad, asymmetric peaks make peak integration far more challenging than chromatography—especially in GMP environments under increasing regulatory scrutiny.

• Despite the critical role of integration in assessing purity and stability, major authoritative sources (USP, EP, JP, WHO, PDA) provide almost no guidance specific to electropherograms, leaving scientists, reviewers, and regulators without a framework for consistent, defensible integration practices.

• The article outlines why automatic integration—while preferred for efficiency and objectivity—often fails for CE, and it establishes clear expectations for when manual integration is scientifically justified, how it must be documented, and what policies, SOPs, and training programs companies must implement to meet data-integrity requirements.

• The work calls for an industry-wide collaboration to create standardised CE integration guidelines, benchmark datasets, and improved software tools—ultimately strengthening analytical reliability across GMP, R&D, clinical, and academic laboratories.

Key Learning Outcomes

• Understand why electropherogram integration is fundamentally more complex than chromatographic integration—including baseline drift, broad/asymmetric peaks, migration-time variability, and data-system limitations.

• Learn the essential components of a defensible CE integration policy and SOP, including required integration parameters, documentation expectations, reviewer qualifications, and criteria for appropriate manual versus automatic integration.

• Gain practical insight into how to strengthen data integrity in GMP and non-GMP labs, with clear guidance on training analysts, standardising integration practices, and preparing for regulatory inspections.

• Recognise the need for, and benefits of, industry-wide harmonisation, including collaborative guideline development, shared benchmark datasets, and enhancements to data-system software for CE workflows.

About

Timothy Blanc is the founder of Biopharm Control Strategy, LLC, a consulting firm focused on analytical strategy, data innovation, and AI-enabled workflows for biopharmaceutical development. Retired from Eli Lilly & Co., where he served as Director of Technical Services / Manufacturing Sciences, Tim led analytical control strategies and comparability assessments for monoclonal antibodies across Lilly’s global network. With over 35 years of industry experience, he has been a long-time leader in the CASSS CE Pharm community, advancing capillary electrophoresis applications and mentoring the next generation of scientists.