Comparative Biosciences, Inc. offers a wide range of biocompatibility testing for various biomaterials including implantation, local irritation, pyrogenicity, sensitization, and multi-dose toxicity testing to meet FDA, ISO, and JMHW standards. Medical devices and their component materials may leach active compounds or have surface characteristics that may have undesirable effects clinically. Biocompatibility testing is used to establish biocompatibility and safety of these materials in a preclinical setting.

Sensitization Testing

Acute, Subacute and Chronic/Carcinogenicity Multi-Dose Studies

Implantation Testing

Implantation tests are useful for the assessment biomaterials that are exposed to the body for an extended duration. Following implantation, clinical signs, body weights, clinical chemistry and histopathology are assessed in rabbits at designated time intervals. Turn around time is about 3 weeks following the end of the in life phase.

Intramuscular Implantation (1-12 weeks)
Subcutaneous Implantation (1-12 weeks)
Long Term Implantation (as per sponsor request)

Local Irritation Testing

Irritation or local reactivity tests assess the local reaction of tissues to biological materials or extracts. Turn around time is 3 weeks except for the vaginal irritation test, which is 7 weeks.

Intracutaneous Irritation
Vaginal Mucosal Irritation
Ocular Irritation
Intraocular Irritation
Primary Skin Irritation

Pyrogenicity Testing

Pyogenicity testing is performed to determine the potential of test materials to induce a pyrogenic (fever) response over a 3-hour period. Turn around time is 3 weeks.

USP Rabbit Pyrogen Test
ISO Rabbit Pyrogen (Materials Mediated)
Rabbit Pyrogen Retest

Sensitization Testing

These tests assess the potential of the test materials to induce a dermal contact sensitization. Irritation or local reactivity tests assess the local reaction of tissues to biological materials or extracts. Turn around time is about 7 weeks.

Guinea Pig Maximization Tests for Sensitization
Guinea Pig Repeated Patch Dermal Sensitization

Acute, Subacute and Chronic/Carcinogenicity Multi-Dose Studies

Multiple dose toxicity studies usually include 6 male and 6 female mice per dose group with vehicle and multiple test material groups. Parameters include survival, clinical observations, body weights, clinical chemistry, necropsy with organ weights, and histopathology. A complete audited report is prepared. Turn around time is 3 weeks for the acute toxicity study, 6 weeks for the subacute studies and 12 weeks or less for the carcinogenicity studies.

Acute Toxicity in Mice (72 hour)
14-Day Subchronic Toxicity Test in Mice
Subchronic Intravenous Toxicity in Mice (5 repeat dose)
Subchronic Intraperitoneal Toxicity in Mice (5 repeat dose)
Subchronic Intravenous Toxicity in Mice (10 repeat dose)
Subchronic Intraperitoneal Toxicity in Mice (10 repeat dose
Chronic Toxicity and Carcinogenicity Studies (2 more years)
USP Safety Test in Mice (Finished Product Release)

All of our GLP Biocompatibility Studies feature

Protocol development
Highly qualified study director with advanced scientific degree
Study calendar with communication of significant study milestones
Highly qualified study biologists
Test article control
Highly qualified experts including board certified pathologist, opthlamologist and cardiologist
Quality Assurance Unit with critical phase audits, master schedule, SOPs, and appropriate training records
Audited final report
Long term archiving of data

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