Analytical Development 101 Day

Your Comprehensive Introduction to Gene Therapy Analytical Development

Want a comprehensive introduction to the analytical development field? Looking to understand basic principles and familiarize yourself with key terms and technologies?

Look no further than our Analytical Development 101 Day, a full-day workshop where you will learn the important foundations to the analytical development field, preparing you and increasing your confidence in the discussions that lie in the deeper-dive days ahead!

Monday, November 30, 7am-12pm PST | 10am-3pm EST

An Introduction to Gene Therapy

  •  Basic biology of the vectors and the importance of analytics (AV, AAV & lentiviral)
  • Exploring different vector stereotypes 
  • What are the main challenges with analytics with respect to other biologics? 
  • Describing the high-level challenges of GTs compared to monoclonal antibodies and relevant challenges, such as potency and impurities

Gael Debauve, Head of Gene Therapy CMC Analytics, UCB

The Gene Therapy Timeline 

  •  Introduction to how the analytics link to the process
  • Timing – how is the product release and shipment with the timeline
  • Getting analytics done and the product out the door in time
  • Interactions of gene therapy departments with regards to key assays

Lyndi Rice, Head of QC Viral Vector Analytical, BioMarin

What are the Assays?

An introduction to the individual assays used in gene therapy analytical development, discussing the advantages and limitations of each, and how they compare to protein analytics.

Bioassays

  • An introduction to the bioassays required: what does each assay mean?
  • What technologies are being used for analysis?
  • In vivo vs in vitro bioassays
  • Highlighting standards and controls

Win Den Cheung, Associate Director, Analytical Development, REGENXBIO

Molecular Biology 

  • What are the basic principles of qPCR and digital PCR? 
  • Detecting impurities and determining genome integrity
  • Introducing Next Generation Sequencing technique

Matthew Hankinson, Associate Director, Analytical Development, Allergan

Analytical Chemistry Techniques

  • An introduction to analytical chromatography techniques
  • Limitations and advantages to the techniques used for vector characterization 

Jeremy Johnston, Director, Analytical Development, AskBio