Near-infrared (NIR) spectroscopy is increasingly evaluated as a rapid, non-destructive analytical tool for pharmaceutical applications; however, its broader use for quantitative excipient analysis in biotherapeutic drug products has been limited by concerns regarding robustness, comparability, and suitability within regulated testing strategies. Advances in NIR instrumentation and data processing now enable rigorous, fit-for-purpose comparison to established analytical methods. This presentation describes assessment of a modern NIR platform designed to generate a list of formulation components and corresponding concentrations from biotherapeutic drug products. NIR-based excipient identification and quantitation were compared directly to validated or qualified reference methods. Performance was evaluated based on agreement, precision, and suitability for at-line use. Recent regulatory guidance, including ICH Q2(R2) and Q14, supports science- and risk-based analytical development, including spectroscopic and multivariate approaches when justified. Although not implemented in regulated testing, these findings support further comparability assessment and lifecycle planning for future pharmaceutical and PAT applications.
Learning Objectives:
Upon completion, participants will be able to evaluate the agreement between modern NIR–derived component identity and concentration results and those obtained using validated excipient analytical methods.
