Thursday 18th September - Main Conference Day ThreeThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

For commercial programs, robust process controls go beyond accuracy and precision, and require reliability, transferability and robustness. In-line spectroscopy-based process analytical technologies (PAT) have created an opportunity to address those concerns. PAT are common in bioprocessing and are highly scalable with a wide range of applications including determining product, solvent, and impurity concentrations. A cross-functional team including development and manufacturing have focused on the implementation and development of in-line near-infrared (NIR) spectroscopy for glycoconjugate programs. Key learnings from development and manufacturing regarding model development, implementation, and validation were analyzed to investigate and expand PAT applications across multiple glycoconjugate programs.