Toxikon is a preclinical contract research organization. The company contracts and partners with biotech, pharmaceutical and medical device industries to deliver product development services from concept to final product.
Featured services: Biocompatibility testing, extractable and leachable testing, microbiology
- Biocompatibility testing: Better understand the potential risk of adverse events with your products through comprehensive biocompatibility testing. Toxikon’s biocompatibility subject matter experts perform high-quality testing and help create the standards that define these programs.
- Extractables and leachable testing: Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in medical devices and pharmaceutical products. The demand for these types of studies by U.S. and other governing bodies is increasing, as data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing and other materials, potentially rendering drug products unsafe. These materials include, but are not limited to polymers and other plastics, elastomers, coatings, accelerants and antioxidants. Toxikon uses a combination of commercially-available reference database as well as a proprietary database, built over the last several decades, based on thousands of studies conducted.
- Microbiology: Microbiological characterization of medical devices typically accompany regulatory submissions and bioburden, endotoxin and tests for sterility are common requirements. These tests are performed according to USP and AAMI guidance. Toxikon’s microbiology department collaborates with clients to develop customized study protocols that meet your specific requirements. Its staff of experienced microbiologists apply their technical expertise when conducting each study to generate timely, quality data to your program’s requirements.
Visit Toxikon at booth #105 at DeviceTalks West, Dec. 11-12.