Pre-Conference Workshops
Monday, November 29 2021 | 09.00AM - 2.00PM EST
Morning Workshops
Workshop A: 09.00am-11.00am EST
Mastering Potency Assays: Your Blueprint to Tackle the Field’s Greatest Analytical Challenge
Your one stop shop for all things potency. Hear from and discuss with industry leaders on topics including, potency assay development strategies & common challenges
Join this workshop to discuss:
- Assessing Best Practice for Selection of Parameters for Assay Validation With Potency Assays
- Long Term Program Management for Potency Assays
- Developing In Vitro Mechanism of Action Potency Assays & Demonstrating Choice of Cell Line
- Understanding & Characterizing the Impact of Deamidation on Potency
Workshop Leader:
Arden Bond
Senior Scientist
AskBio
Eric Crampon
Analytics & Bioassay Lead
Takeda
Workshop B: 9.00am-11.00am EST
Reference Standard Materials 101
Join to discuss the “What, Why & How” for Reference Standards in the gene therapy field. Including types, uses and when they have to be changed.
Join this workshop to discuss:
- What are the different types of reference standards and what are their uses?
- When do I need a product reference standard and how and when are these changed?
- How should in-house reference materials be tested and controlled?
- Dossier requirements for approval
Workshop Leader:
Christopher Bravery
Independent Consultant
Workshop C: 09.00am-11.00am EST
AAV Full-Empty Characterization
Empty full characterizations stands as one of the greatest challenges in gene therapy analytics. Join to discuss analytical approaches for empty full characterization and understand how common hurdles can be overcome
Join this workshop to discuss:
- Best Practice Analytical Methods for Empty Full Characterization
- Alternative Methods to AUC for Empty-Full Characterization
- Strategies to Validate Empty-Full Characterization Without 100% empty and Full Capsid Samples
Workshop Leaders:
Nicholas Larson
Scientist
Biogen
Afternoon Workshops
Workshop D: 12.00pm-2.00pm EST
Transferring a Complex Analytical Method to Quality Control
As new analytical methodologies continue to come to the forefront it is hugely important they can be moved into the QC environment. Join to understand how such hurdles can be overcome.
Join this workshop to discuss:
- How to bring New Technologies & Analytical Approaches into a QC Environment
- Challenges of moving new and complex analytical methodologies into a QC environment
- What makes an analytical assay QC friendly?
Workshop Leader:
Dwayne Neal
Senior Director Analytical Validation
Avrobio
Workshop E: 12.00pm-2.00pm EST
Process Control & Process Analytics
Discuss how analytical and process development can marry together to reduce variability in results. Learn how choose the optimum process analytical strategy
Join this workshop to discuss:
- The greatest challenges with the use of analytics in the context of process development
- Best practice and strategy development to deduce variability in analytics
- How to chose optimum process analytics
Workshop Leader:
Bill Janssen
Independent Consultant
Workshop F: 12.00pm-2.00pm EST
Stability-Indicating Assays for AAV-Based Vectors
- AAV-based vectors used in Gene Therapy are new and complex modalities both in terms of structure and function.
- The mechanism of action of viral vectors is multifaceted, which requires matrixed approach for assessment of biological activity
Join this workshop to discuss:
- Stability-indicating methods for AAV-based vectors
- Challenges and opportunities for structure-activity relationship studies in the context of developing stability indicating assays
Workshop Leader:
Marina Feschenko
Director, Analytical Development
Biogen