Cell therapies are inherently complex
Unlike traditional pharmaceutical compounds that can often be defined by a specific molecular structure, cellular products consist of dynamic living populations whose characteristics may change in response to their biological and manufacturing environment.
Understanding the product therefore requires multidimensional characterization.
A central area of the TISTR and Vega Wellness development program is allogeneic umbilical cord-derived mesenchymal stromal/stem cell technology.
Umbilical cord tissue provides a source of mesenchymal stromal cells that can be isolated, expanded and characterized within controlled manufacturing processes.
Donor Qualification
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Tissue Procurement
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Cell Isolation
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Cell Banking
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Expansion
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Harvesting
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Formulation
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Quality Control
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Release
Variability introduced at any stage may potentially influence the final cellular product.
Cell identity is established through a combination of biological characteristics rather than cell count alone.
Depending on the stage and purpose of development, characterization strategies may incorporate:
Manufacturing processes must preserve appropriate cellular characteristics during expansion.
Relevant parameters may include:
High viability is important but viability does not by itself demonstrate biological function.
Potency assays are intended to evaluate measurable biological activity associated with a product’s proposed mechanism or functional characteristics.
Depending on the investigational application, research may evaluate biological functions associated with:
Potency development is therefore an important component of advanced cellular-product characterization.
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