Potency Assays for Mesenchymal Tissue Regeneration
Organized by the European LRA
Chair: Massimo Dominici, MD, Assistant Professor, University of Modena
Speakers: Massimo Dominici, Wilfried Dalemans, PhD, TiGenix NV, Bob Deans, PhD, Athersys Inc.
About the Webinar:
One fundamental aspect in translating pre-clinical results into safe and performing cellular therapy products during cell production and at the time of release is to establish dedicated potency assays.
These tests should address the following questions "How is it working? Will it always work? Can you measure that?” providing reproducible and standard insights capable to measure biological activity for the intended use.
The IHC guideline Q6B specifies that a potency assay shall be "the measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties”. Moreover, it is stating that "Potency is the quantitative measure of biological activity based on the attribute of the product which is linked to the relevant biological properties” additionally adding that "A correlation between the expected clinical response and the activity in the biological assay should be established in pharmacodynamics or clinical studies.”
While this is quite established for defined molecule-based therapies with precise mechanisms, potency assays for cell-based therapeutics has been historically challenging since living cells act by a series of factors sometimes difficult to define.
During this webinar we will address how it is possible to establish potency assays for adult multipotent mesenchymal progenitors by distinct strategies dissecting both cellular differentiation and soluble factors release. Two distinct paradigms of cell-based regeneration will be proposed, on one side bone regeneration and on the other side cardiac repair. These experiences will be shared by either an academic lab or industry, providing evidence on the feasibility in establishing potency assays for adult mesenchymal progenitors.
Wilfried Dalemans, PhD
Officer, Tigenix NV, Belgium
"Potency assay development for an
autologous cartilage repair cell product”
- ChondroCelect, an approved ATMP for cartilage repair
- Potency, general considerations and challenges for an autologous product
- Potency of expanded cartilage cells, looking from different angles
- Potency development for a routine setting
Member ISCT EU LRA Committee, ISCT
CAT-EMA RepresentativeUniversity of Modena and Reggio Emilia, Modena, Italy
"Developing potency assays for bone regeneration at academic level”
- BM-MSC in Phase II trial-REBORNE CONSORTIUM - FP7 EC PROJECT
- Development of potency assay by molecular analyses
- Development of potency assay by 2D cultures
- Development of potency assay by 3D cultures
Chair ISCT Commercialization
Executive Vice President of Regenerative Medicine, Athersys, Inc ,
"Adherent Stem Cells in Treatment of Ischemic Cardiovascular Injury:
Angiogenic Potency Assays”
- Bone marrow stem cells in Phase I/II development
- Establishing pass/fail criteria for lot release
- Secretion of VEGF, IL8 and CXCL5 (ELISA)
- MultiStem(R), and adherent stem cell product
This product is a downloadable PDF and provides a link to an mp4 video recording of the webinar.