Wednesday Afternoon Session on Biopharmaceuticals Analysis

This parallel session, entitled “Biopharmaceuticals: Forward Looking,” is co-chaired by Peter Yehl of Genentech, Inc. and Samuel Foster of Rowan University in Glassboro, New Jersey, USA. It will be held from 3:45 to 6:00 pm in the Palm Rooms 1-2-3.

Kicking off the session, Cong Bi of Bristol-Meyers Squibb will present a keynote lecture titled “Development and Optimization of a Robust HPLC Method for Analytical Process Control of a Pharmaceutical Intermediate.”

Following at 4:15, will be Sissi White of Thermo Fisher Scientific delivering a keynote lecture about the characterization of lipid nanoparticle (LNP) composition using ultrahigh-pressure liquid chromatography with charged aerosol detection (UHPLC–CAD).

At 4:45, Jean-Marc Roussel of JM Rousell Consulting will present a keynote lecture titled “Improving the Interpretation of Robustness Studies: Managing the Leap into the Real World.”

Next, at 5:15, Shanhua Lin of Thermo Fisher Scientific will present new insights into the chromatography mechanisms of ion-exchange charge variant analysis, during which a discussion about dispelling myths and providing guidance for robust method optimization will take place.

The following presentation will be given at 5:30 and will be led by Stephen Groskreutz of Eli Lilly and Company. The talk is titled “Continuous Manufacturing of Tirzepatide using Online UHPLC-based PAT: An Enabling Technology for Commercialization of a Synthetic Peptide.”

The final presentation will be led by Georgy Cooney of S-Matrix Corporation Inc. Cooney will describe QbD experimentation supporting all stages of analytical procedure lifecycle management (APLM) with the Fusion Qbd software.