Quality & Safety

Nanotein assessed the NanoSpark activator with adherence to rigorous ISO 10993 standards in preparation for GMP manufacturing. The composition of the NanoSpark reagent is protein-based, and consequently naturally biodegradable, which provides a significant safety advantage over magnetic bead-based and synthetic products. A reputable medical device CRO was commissioned to complete the in vitro & in vivo ISO 10993 biocompatibility testing. The tests were run at >20X the predicted possible carry-over amount, which resulted in no toxicity or adverse effects:

ISO 10993 Biocompatibility Testing	Test	Type of Test	Result	Product Tested
ISO 10993-5	Cytotoxicity	In vitro	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-10	Sensitization	In vivo: Guinea Pig	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-10	Irritation/Intracutaneous Reactivity	In vivo: Rabbits	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-11	Acute Systemic Toxicity	In vivo: Mice	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-11	Pyrogenicity	In vivo: Rabbits	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-4	Hemocompatibility	In vitro	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-3	Genotoxicity Ames	In vitro	No Toxicity/Adverse Effect	NanoSpark STEM-T
ISO 10993-3	Genotoxicity Mouse Lymphoma Forward Mutation	In vitro	No Toxicity/Adverse Effect	NanoSpark STEM-T

Purchase The NanoSpark STEM-T Soluble T Cell Activator

The NanoSpark STEM-T Soluble T Cell Activator reagent kit is an easy-to-use T cell activator for T cell expansion, including CAR-T cells.

Quality & Safety

Purchase The NanoSpark STEM-T Soluble T Cell Activator

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