Yesterday, at World Stem Cells & Regenerative Medicine Congress 2012, Paula Salmikangas, Co-ordinating Senior Research, Finnish Medicines Research, Vice Chair, Committee for Advanced Therapies (CAT), presented the regulators principle manufacturing issues of cell therapies.
Dr Salmikangas’s focus was upon manufacturing quality and the key challenges that need to be addressed:
- Bioequivalence: how do you show full quality compatibility between cell products?Â It’s practically impossible, so means are required to address this.Â And then there is the fact that very small changes in the cell culture environment can lead to significant variances in cell phenotype.
- Raw materials: generally, they are of research grade. Never mind the upscale of manufacturing, how are you going to ensure the quality and quantity of supply?Â Add to that the need for potency testing, the need to show a link between product quality to clinical outcome, compatibility tests, the particular requirements for first in man studies.
The heavy GMP requirements fall heavily on the typically academic sector which is undertaking early stage trials: a significant impediment to translation which needs to be addressed, said Dr Salminkangas.
Check back here in a couple of days for the presentation. Excellent presentation Paula!