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.