Post-Conference Cell Therapy Focus Day

** The post-conference focus day is only available to attend in person **

Friday, April 1

10:00 am Registration & Coffee Break

10:30 am Chairperson’s Opening Remarks

  • Ann F Durbin Associate Director, Assay Development, Abeona Therapeutics

10:39 am
FRAMEWORKS TO ADOPT FOR CELL THERAPY SPECIFIC COMPARABILITY DESIGNS

10:40 am Using Systems Analysis of Products & Enhanced Process Controls to Assure Product Potency & Uniformity

  • Allan B. Dietz, Ph.D. Director, Immune Progenitor and Stem Cell lab (IMPACT), Associate Professor of Laboratory Medicine, Associate Professor of Immunology, Mayo Clinic

Synopsis

  • Moving cell products to licensure requires sufficient characterization to assure product safety and importance
  • Dr Dietz will describe their philosophical approach toward discovery of purity and potency markers using systems biology (RNA-Seq; Secretome; Surfactome) and thoughts around next level process controls and analytics to support process integrity

11:20 am Virtual Presentation: How to Adopt a Quality By Design (QbD) Framework to Assess the Inputs Required For an Effective Cell Therapy Comparability Assessment

Synopsis

  • An exemplar approach of adopting QbD principles for cell & gene therapy to define:
    • Critical quality attributes to test
    • Critical starting material attributes to test
    • Discuss the need to set comparability exercise considering change impact
    • Specific criteria to establish clear product comparability

12:00 pm Lunch

1:30 pm Assessing How to Demonstrate Comparability Whilst Balancing The Unique Challenges of an Autologous Approach

Synopsis

  • Assessing How to Demonstrate Comparability Whilst Balancing The Unique Challenges of an Autologous Approach

2:10 pm Case Study: Demonstrating Autologous Cell Therapy Comparability Upon Changing Viral Vector Manufacturing Facilities

  • Ann F Durbin Associate Director, Assay Development, Abeona Therapeutics

Synopsis

  • How to prioritize analytical assays applicable to the comparability study
  • Example of demonstrating analytical comparability for both the viral vector, and for the autologous cell therapy drug product

2:49 pm
NAVIGATING CHANGES IN CELL THERAPY MANUFACTURING PLATFORMS

2:50 pm Case Study: How to Adapt Comparability Tests When Navigating Changes In Process Development

Synopsis

  • Learn how to best reinforce comparability design from early stage development
  • Assess the need for stage related comparability tests from starting material to the downstream cell product

3:30 pm Closing remarks

  • Ann F Durbin Associate Director, Assay Development, Abeona Therapeutics