Biocompatibility testing of polymers: in vitro studies with in vivo correlation.

An in vitro method has been developed for screening of candidate biomaterials in an early phase of their development. The test is based on L-929 mouse fibroblast cultures and their response to powdered polymer samples. It applies microscopic observation for the detection of morphological changes, uses dye exclusion testing for cell viability determination, and utilizes estimation of population doublings as an end point. The test is shown to be reliable and reproducible and is compared to in vivo implantation studies in rats, previously reported.