Breakout Discussion Groups provide the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.
Tuesday, August 25 | 3:10 PM
Continuous Manufacturing of Gene Therapy Products: How Far from Reality?
Moderator: Ricardo J.S. Silva, PhD, Senior Scientist, Downstream Process Development, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
- GT products such as AAV will require different dose levels depending on the application
- Are the technologies used for continuous processing suitable for both production scales?
- What are the opportunities provided by continuous manufacturing: only footprint reduction?
- What are the technical challenges for implementing continuous processing in GT?
- Should all the processing be continuous? Will it even be possible? USP Challenges and DSP Challenges
- What type of technologies and materials are still missing? - Bioreactors? Filtration devices? Affinity chromatography? Better or improved cell lines?
Host Cell Proteins Characterization for Bioprocess Development
Moderator: Shawn Li, PhD, Associate Principal Scientist, Analytical Research and Development (AR&D) Mass Spectrometry, Merck & Co., Inc.
- What are existing HCP characterization toolkit?
- What are strategies for HCP ID and quantification?
- How LC-MS data fits into biologics CMC process development?
- How to tackle extremely low levels of residual HCPs, like lipase?
Protein Structure Elucidation with Spectroscopy
Moderator: Rina K Dukor, PhD, President & Co Founder, BioTools Inc.
- What technique(s) to use for different applications in upstream and downstream bioprocessing?
- Error bars in spectroscopic measurements; what are the best ways to determine them?
Comparability for Cell and Gene Therapies
Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.
Scott R Burger, Principal, Advanced Cell & Gene Therapy LLC
- Process changes and demonstrating comparability
- Coping with short development time frames
- Using surrogate material
- Determining the right assay panel
Friday, August 28 | 11:35 AM
How Quick A Cell Line Specific HCP Assay Can Be Developed, Qualified/Validated
Moderator: Bryant Yan, PhD, Senior Director, Analytical Development and Quality Control, Acceleron Pharma
- What are the requirements for BLA filing?
- How long does it take to complete it?
- How often this can be a PMC?
Challenges and Opportunities of Analytical Development for Novel Manufacturing Platforms
Moderator: Elena A. Smith, PhD, Deputy Director, Quality Control, Sanofi Group
- Adaptation of traditional methods vs alternative methods as a first choice
- Regulatory challenges for analytical control for the new manufacturing platforms
- Standards and reference materials for novel manufacturing platforms
- In process control for novel manufacturing platforms
- Cell Therapy CMC and Analytics