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08:30 09:00 (30 mins)

Main agenda

Registration and Morning Coffee

09:00 16:00 (420 mins)

Main agenda

Applying new technologies to ATMPs: Gene Editing and CRISPR

  • Workshops will finish no later than 16:00
  • Refreshments, documents and a lunch will be provided
  • James Smith - Research Associate and Associate, CAMSI Translational Stem Cell Consortium and IP Asset Ventures, UK
  • David Brindley - Senior Research Fellow, University of Oxford, Managing Partner, IPAV, UK

09:00 16:00 (420 mins)

Main agenda

Comparability for ATMPs

Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging, for cell, gene and tissue products that cannot be fully characterised the challenges are greater still. Concerns about comparability undertaken during development are common issues raised during review and often delay market approval or contribute to failure. This course explains what comparability is and how to develop a successful comparability protocol.

Workshop Learning Overview

• What is comparability?

• Why is meeting existing specifications not comparability?

• How do I apply the principles of comparability to highly variable products?

• Case studies: Common mistakes with comparability and their consequences.

• Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study.

  • Christopher Bravery - Director, Consulting on Advanced Biologicals Ltd., UK
  • Karin Hoogendoorn - CMC Manager ATMPs, Utrecht University Medical Centre, Cell Therapy Facility , The Netherlands

12:00 16:00 (240 mins)

Main agenda

Viral Safety for ATMPs

Topics to be discussed include:

  • Regulatory Overview
  • Human-derived Raw Materials
  • Animal-derived & Recombinant Raw Materials
  • Viral Safety Concepts for ATMPs
  • Alison Wilson - Principal Consultant, CellData Services
  • Thomas R. Kreil - Senior Director, Global Pathogen Safety, Shire, Austria
  • Albert Stühler - Deputy Head, Virus Safety, Paul-Ehrlich-Institut