Whether you’ve contracted for pre-clinical testing before or you’re approaching the process for the first time, you may have key questions about APS’s preclinical animal models and testing capabilities.
The scientific community understands the vital importance of conducting the crucial pre-clinical tests before risking similar testing on humans. Through the years animal research has led to major medical breakthroughs involving penicillin, blood transfusion, tuberculosis, macular degeneration, asthma, meningitis, kidney transplants, breast cancer, Parkinson’s disease and insulin.
“Americans are living longer, healthier lives and we owe much of that success to biomedical research,” notes Robert Palazzo, president of the Federation of American Societies for Experimental Biology.
To help our clients understand the facets of our animal model capabilities, here are answers to some of their most common questions.
Q: What animal models are most frequently used for testing at APS?
A: APS works with all large and small research animal species except primates, but pigs are the most common. APS has the capacity to perform both large safety studies and small feasibility studies.
Q: What types of APS animal models are suited for gastroenterology-related devices?
A: We make those decisions based on direct experience and/or the literature and papers published on specific animal models being used. We usually recommend our clients discuss those choices with our surgeons who have experience in that space. This can be very device specific but we have performed gastroenterology procedures primarily on porcine models. We do have the capabilities to utilize other models if the porcine model does not work well for the device in question.
Q: Describe the experience of your researchers in testing specific device systems
A: Our scientists have had experience testing most major categories of medical devices. If we’re asked to test a product with which we haven’t had direct experience, we will discuss that with you and volunteer to conduct extra training and/or wet lab work before beginning your testing process. “There are definitely circumstances in which a client wants us to get more experience,” notes APS Business Development Associate Monica Tantalean. “We work in research, so we’re definitely open to researching, reading papers or anything else we need to try to get an idea of how best to meet clients’ needs.”
Q: What are your imaging capabilities?
A: We have the ability to do most imaging in house except for MRIs, which we’re able to perform with a local trusted partner. Our capabilities include intracardiac and duplex ultrasound, endoscopy, laparoscopy, intravascular imaging, electrophysiology mapping, fluoroscopy and CT. “If there’s something we don’t do, we have the ability to subcontract it out,” notes Tantalean.
Q: Why does APS recommend the GLP study be conducted after, not before, non-GLP testing?
A: Doing the less-rigorous non-GLP study first offers flexibility if something about the device needs to be changed or updated prior to GLP testing. GLP testing should be reserved for devices that are in their final iteration of development and no further updates are expected.
Q: Can you cite an example of how APS is seeking animal testing alternatives?
A: We were awarded the AAALAC’s Global 3Rs Award for developing a methodology called the In-vitro Blood Loop Assay that can accurately test thrombogenicity on its own without involving implantation in animals. The test was developed on-site over a three-year period and is expected to substantially reduce the number of research animals used in such testing nationwide.
Q: Besides in-vivo testing, what other services can APS provide to help further my product?
A: Our goal is to help you solve any obstacles that stand in the way of getting your product to market. That means we offer a range of related services, from in-vitro forms of product testing to analytical testing and bioskills.
Still have questions about how APS will manage your animal testing process? Contact us to learn more about how we can help you get your promising new product closer to market.