Is it possible that in vitro models will someday become so sophisticated and thorough that they are able to predict biocompatibility as well as an in vivo model — saving time and money (not to mention providing some relief to our furry friends)? Dr. Joel Gorski, Director of Research and Development for North American Science Associates (NAMSA), believes that day will come — but it will take a lot of hard work.
"If we're trying to get an in vitro process to replace animal testing, it has to be very effective," Gorski said. CeeTox, Inc (Kalamazoo, MI), a NAMSA subsidiary, recently received some help in the form of a contract from the U.S. Environmental Protection Agency's ToxCast™ Program to develop in vitro assays that could be deployed to identify and predict in vivo toxicity of thousands of compounds.
Gorski anticipates that these in vitro techniques could also be applicable the medical device industry — and provide a "better, faster, cheaper" way for medical device manufacturers to test certain compounds. Biocompatibility analyses like the sensitization test currently use guinea pigs to determine whether or not a device or device extract will elicit an immune system reaction from repeated exposures.
Gorski believes that if global regulatory bodies like the FDA and the Japanese Health Organization participate in round robin studies that evaluate in vitro techniques, they will eventually get a good shot at regulatory acceptance. In the meantime, in vitro testing remains a useful resource for compiling databases of toxicological risk assessments for compounds and formulations.
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