Toxicology Testing for Devices

WuXi AppTec offers in-vivo and in-vitro non-clinical safety evaluation programs in our St. Paul facility tailored to meet the unique needs of medical devices, combination products and their constituent components. As the uniqueness of each product requires a case-by-case approach, we partner with clients to ensure that all study components meet specific program objectives.

Testing services are based on the current global regulatory guidelines and requirements, and our quality systems have been audited and accepted by regulatory authorities worldwide. WuXi AppTec scientists have extensive experience in designing non-clinical safety testing programs, and our services have supported a number of successful regulatory submissions in the U.S., Europe and Asia.

St. Paul Facility

Building on our many years of experience providing quality testing services to the pharmaceutical, biologics and medical device industries, WuXi AppTec is continually growing and enhancing its toxicology program at its St. Paul facility.

WuXi AppTec's scientists and staff have extensive experience in designing, developing, and conducting testing programs. The St. Paul facility is FDA registered and ISO 17025 certified. Additional qualifications include AAALAC and AALAS accreditation, and USDA and DEA licenses.

With WuXi AppTec's depth of expertise and its expanded facilities, including on-site clinical pathology, on-site histopathology, and on-site QA, our clients are assured they will receive the highest level of service for their toxicology studies.

Testing Services

Acute Toxicity (in-vivo)

Range Finding

  • Up/Down
  • Limit Test
  • Maximum Tolerated Dose (MTD)

Fixed Dose
Local Tolerance

Repeat Exposure (in-vivo)

Range Finding
Subacute
Subchronic
Chronic

Genotoxicity (in-vitro and in-vivo)

In-vitro Bacterial Mutagenicity
In-vitro Mouse Lymphoma
In-vitro Chromosomal Aberrations
In-vivo Mouse Micronucleus

Tumorigenicity



Biodistribution

Pharmacokinetics/Toxicokinetics
Tissue Collection qPCR Analysis

Immunotoxicity

Delayed-type Hypersensitivity
Anaphylaxis

Study Components

Available Animal Models

Mice (athymic and normothymic)
Rats (athymic and normothymic)
Rabbits
Canines
Caprine
Ovine

Dose Administration Routes

Dermal
Intraperitoneal
Intracardiac
Intracranial
Oral
Intradermal
Subcutaneous
Intramuscular
Intravenous (bolus)
Intravenous (continuous infusion)

Clinical Pathology

Serum Chemistry
Hematology
Coagulation
Urinalysis

Anatomic Pathology

Histology/Histopathology
Paraffin Sections

For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products OR click here to access a collection of PDF literature available for viewing and printing.