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.