WORKSHOP ORGANIZERS IN 2024
14h00
Point-of-need analytics and process analytical technologies: 4 case studies
- Plenary
Chairman
Waters invites you to explore point-of-need analytics for CQA monitoring and process analytical technologies for both upstream and downstream operations, featuring real-world case scenarios.
10h00
POINT-OF-NEED PRODUCT ATTRIBUTE ANALYTICS
From early-stage screening to QA/QC monitoring.
Case Study 1
Early-stage determination of the correct pairing of multi-specific mAbs, using rapid LC-MS and LC-MALS methods.
High-throughput direct identification of constructs and measurement of quality attributes, including glycoforms and low molecular weight components.
Case Study 2
Deployment of Multiple-Attribute Method (MAM) for QC Analytical Testing and Replacement of Conventional Methods.
Opportunities and challenges associated with release and stability testing. Zoom on specific features like New Peak Detection to ensure batch production consistency.
10h00
PROCESS ANALYTICAL TECHNOLOGIES
From clone selection and upstream bioprocess development to downstream on-line monitoring.
Case Study 3
Expedite Process Development with Automated PQA and Spent Media Analysis with LC-MS Walkup Solutions.
Rapid product quality attribute (PQA) and media metabolite analysis help understand how process parameters affect product quality and facilitates process troubleshooting.
Case Study 4
In-line and on-line monitoring of CQAs for biologics & vaccines by RT-MALS.
This novel PAT characterizes key biophysical attributes and integrates with downstream processes to monitor aggregation, distinguish product from impurities, and identify process endpoints.
15h30