Translational process validation: a multi-faceted gem

November 12, from 11:20 am to 1:20 pm - Ontario Room at the Westin Hotel, Ottawa

This workshop will guide participants through the decision-making and the steps involved in translational process validation. Participants will learn through real case studies the steps involved in validating workflow, biomarkers, equipment and developing a QA/QC program necessary to translate cell and gene therapies out of the research laboratory.

Speakers will describe validation steps that were required to adapt cellular therapy production from pre-clinical research into GMP workflow for clinical trials using appropriate equipment, supplies and materials. The emphasis will be on how it was accomplished to advance knowledge on translating therapeutic discoveries.

	Autologous bilayered self-assembled skin substitutes (SASSs) as permanent grafts – clinical effectiveness for severely burned patients Friederike Pfau, LOEX, Centre de recherche du CHU de Québec-Université de Laval, Regenerative Medicine Division
	Cellular therapy product adaptation to GMP manufacturing workflow – overcoming obstacles and efficient validation Dr. David Courtman, Biotherapeutics Manufacturing Centre, The Ottawa Hospital Research Institute