Toxikon's In Vitro Diagnostics for Medical Devices

 A Consultative and Customized Approach

Toxikon’s can customize any study to assist you in advancing your product through clinical development and, ultimately, into global markets safely and in a timely manner. Toxikon’s integrated in vitro services are designed to address evolving challenges specific to evaluating the safety and efficacy of medical devices.  As a preclinical leader in life sciences, we understand the distinct intricacies of a safety evaluation. With more than 30 years of experience, we strive to be more than just contractor.  At Toxikon, we are committed to collaborating with you to develop testing programs. Our services are comprehensive, from translational medicine to surgical and pathology, and imaging capabilities. Our expertise includes, but is not limited to, ophthalmic, orthopedic, cardiovascular and neurologic device development, while our spectrum of studies includes:

• Molecular Biology/Virology:Detection of human and animal viruses in cell lines, mycoplasm testing, purification process validation for human derived blood products, and other tests
• Microbiology:  Routine lot release programs, bioburden determination, endotoxin evaluation, sterility testing, reusable device processing (cleaning, disinfection, and sterilization), validations, microbial or viral ingress assessments, antimicrobial efficacy, as well as packaging, product shelf life and life cycle validations. 
• Metabolism: Prediction of cytochrome p450 induction and drug-drug interactions, as well as metabolite profiling and stability testing
• Genetic and Molecular Toxicology: Ames assays, cell transformation, CHO chromosomal aberration and gene mutation assays, and lymphocyte assays
• Immunotoxcity/Cytotoxicity: Agar overlay, clonal assay, direct contact, inhibition of cell growth assays, and MEM elution, flow cytometry, and other methodologies.
• Culture Based Assays: Cell proliferation and cytokine production
• Binding Assays: RIA, immunodiffusion, and EIA/ELISA assays