Method for the determination of botulinum neurotoxin biological activity
US-9212355-B2 · Dec 15, 2015 · US
US8945847B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-8945847-B2 |
| Application number | US-201113114102-A |
| Country | US |
| Kind code | B2 |
| Filing date | May 24, 2011 |
| Priority date | May 24, 2010 |
| Publication date | Feb 3, 2015 |
| Grant date | Feb 3, 2015 |
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A method of ascertaining the bio-safety of an agent is disclosed. The method comprises: (a) contacting the agent with differentiating human pluripotent stem cells; (b) analyzing a level of gene expression of a plurality of genes in the differentiating human pluripotent stem cells, wherein the agent is qualified as being safe if at least one of the following qualification parameters are fulfilled: (i) the agent causes a difference in the level of gene expression below a predetermined number of genes as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent; (ii) the agent causes a difference in gene expression below a predetermined number of tissue-specific genes of a tissue as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent; or (iii) the agent causes a difference in gene expression below a predetermined number of genes involved in fetal development as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent.
Opening claim text (preview).
What is claimed is: 1. A method of ascertaining the bio-safety of an agent, the method comprising: (a) generating embryoid bodies from human pluripotent stem cells: (b) contacting the agent with said embryoid bodies concomitant with said generating or following said generating; (c) analyzing a level of gene expression of more than 4000 random, non-biased genes in said embryoid bodies; and (d) when said agent is qualified as being safe, testing said agent on an animal model t…
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