Pre-Conference Focus Day

9:30am | Virtual Coffee Morning

9:55am | Chair’s Opening Remarks

Deciphering Isolation Techniques that Translate to GMP level

10:00 am Exosome Isolation & Subtyping for Precision Therapeutic Development

  • Mei He Assistant Professor, University of Florida

Synopsis

  • Novel exosome isolation methods and subtyping
  • Precision molecular characterization of purified exosomes
  • Exosome engineering, manufacturing, and scaling up

10:30 am A Scalable Bioprocess & Analytical Suite for Engineered EV Therapeutic Products

Synopsis

  • Designing a scalable and modular EV bioprocess for engineered EVs
  • Isolating high purity EVs while maintain EV integrity and stability
  • Developing analytical methods and QC in-process release assay to ensure lot-to-lot consistency

11:00 am Characterization of Exosomes for Clinical Applications

Synopsis

  • Importance of exosome characterization and current challenges
  • Methods for exosome characterization
  • Ensuring reproducible exosome isolation to support clinical efforts

11:30 am Live Presenter Q&A

Synopsis

  • Ask the speakers your most burning questions!

12:00pm | Roundtable Discussion: Understanding How to Standardize Isolation Techniques

Synopsis

  • How to isolate and purify exosomes to a specific subpopulation
  • Determining whether to isolate by size or by markers
  • Analyzing different isolation methodologies for exosomes
  • How to translate to GMP level

12:45pm | Virtual Speed Networking

Synopsis

Grab a coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

1:30pm | Networking Lunch

Developing Systems to Successfully Reproduce the Large Scale Manufacturing of Exosomes

2:00 pm Recent Advances in Cation Exchange Purification of Exosomes

Synopsis

  • Exosome therapeutics will necessarily require consistent and economical purification of exosomes in a cGMP context
  • Cation exchange provides a highly scalable, low-cost unit operation for exosome purification from conditioned media and biological fluids
  • When combined with other unit operations, the overall efficiency of capture or end product purity can be optimized

2:30 pm Automated System Development for Scalable, 3D Biological Product Manufacture

Synopsis

  • Limitations and challenges to current cell and cell-based product manufacturing approaches
  • Innovative strategies for 3D cell/organoid culture
  • Innovative strategies for closed-system, clinical-grade culture automation

3:00 pm Compatible Angiogenic Exosome Processing Toward Therapeutic Application of Stroke Model

Synopsis

  • Generate good manufacturing practice (GMP) grade therapeutic exosomes from clonal endothelial progenitor cell lines derived from human pluripotent stem cells (PureStem®)
  • Develop purification methodologies to achieve a robust and scalable exosome production compatible with GMP for clinical grade PureStemexosomes
  • Demonstrate PureStem-exosomes as a resource in EV therapies for stroke and other ischemic disease models

3:30 pm Live Presenter Q&A

Synopsis

  • Ask the speakers your most burning questions!

4:00pm | End of Pre-Conference Focus Day