Building an Analytical Development Strategy to Best Support Process Development
Time: 9:00 am
day: Pre-Conference Day Track A
Details:
Effectively defining virus quality is the heart of successful gene therapy product development. Process analytical technology (PAT) is essential to providing information on critical quality attributes (CQAs) throughout the manufacturing process and QC release testing. Realtime process feedback is essential for increased process monitoring and control to ensure manufacturing success, but often critical process feedback is delayed due to lengthy testing times. Consequently a harmonised and efficient approach to-process analytics is hugely advantageous.
This workshop will set out to address:
• Defining standard operating procedures and analytical standards in quality control
• Analytical standards for the characterisation and stability of raw materials: setting up analytical standard stability programmes and characterising off-the-shelf-material to track stability
• Addressing challenges in scaling up the upstream/ downstream process development
• Enhancing bridging assay transfer from analytical development to quality control
• Strengthening the link between quality and process development teams: enhancing communication, knowledge transfer, and manufacturing/PD in GMP investigations
• Ensuring product compliancy and quality in analytical assays, and discussing methods of handling complex functional assays in the QC team
