SAPA Annual Conference (Gold Corporate Sponsorship)

Date: 9/27-28 

Location: Hyatt Regency New Brunswick, NJ 

Attendee: 

• Ye Gu, Ph.D., Co-founder, CTO and Head of US BD for Crystal Bio 

• Derik McCarthy, SME 
  

• Mailisi Heshuote, Senior BD-Marketing Manager 
  

Speech title for CMC & Outsourcing session (9/27): Leveraging High Resolution Mass Spectrometry and Advanced Analytical Techniques in Biologics CMC Development 

Abstract: Analytical sciences are pivotal in the development of biologics, particularly within the realm of Chemistry, Manufacturing, and Controls (CMC). Employing phase-appropriate strategies is crucial to ensure that analyses are tailored to each stage of development. The use of advanced techniques, such as high-resolution mass spectrometry, can significantly reduce risks and prevent delays when applied effectively and timely. This presentation will delve into the application of high-resolution mass spectrometry and other state-of-the-art analytical tools throughout various stages of biologics CMC development. It will also present case studies on developability assessment, clone selection, and serum stability studies to highlight the practical impact of these techniques. 

Link: https://www.sapaweb.org/ac-2024