Design and Development of Potency Assays for an Autologous Cell Therapy for Alzheimer's Disease

Professor Michael Valenzuela
Scientific Co-Founder
Skin2Neuron Pty Ltd

Hair follicle-derived neuroprecursors (HFNs) are transiently amplifying, neuronally-committed cells that can be efficiently and reliably manufactured from adult skin using Skin2Neuron's proprietary technology. Proof of concept studies have been conducted in rodents and canines ,suggest potential as a treatment for Alzheimer’s Disease (AD) –  donor cells survive, migrate and engraft in host brain memory circuits, restore depleted synapses, and rescue memory deficits to normal function.

However, for human clinical trial and a path to commercialization, a detailed understanding of the cells’ Critical Quality Attributes (CQAs) is needed, including potency criteria. These can be challenging to define because cells are living organisms with multiple potential mechanisms of action.

In this webinar, Prof Michael Valenzuela will be sharing Skin2Neutron's research in potency assays to better understand HFN cell mechanisms and
(i) batch-to-batch variability through Chemotaxis &
ii) Electrophysiologic function.

The development of two in vitro assays for chemotaxis and neurofunctionality derived using the Sartorius S3 Neurosystem will be presented, part of a comprehensive quality control system for the manufacture of clinical grade HFN cells.

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