We offer market-leading expertise in cytotoxicity assays. Our scientists use cell culture assays to assess the biocompatibility of a material or extract through an in vitro reaction of mammalian cells following exposure. These may be plastics or elastomers used as containers or to seal containers that will hold drugs or other solutions for parenteral administration (e.g., intravenous (IV) bags, IV tubing), plastics that will directly contact the patient (e.g., knee brace material, dentures, contact lenses, catheters) or materials that may be implanted (e.g., medical devices: joint replacements or cochlear implants).
Biological reactivity techniques are useful in evaluating the potential of materials and chemicals to have toxic properties. They provide a way to screen materials prior to, or in lieu of, in vivo tests.
We perform three methods of cytotoxicity testing as outlined by the USP:
- Elution Assay: Uses different extracting media and extraction conditions to test devices according to actual use conditions or to exaggerate those conditions
- Direct Contact Procedure: Recommended for low-density materials, such as contact lens polymers
- Agar Diffusion Assay: Appropriate for high-density materials, such as elastomeric closures
Our experts can also perform ISO or custom methods for cytotoxicity tests, as well as quantitative assays that employ techniques to measure cell viability after exposure.
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