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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 |
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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.
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