SEDL / STP / STP810-EB / STP30153S

Tissue-Culture Biocompatibility Testing Program

Johnson, HJ
Manager and associate director, Travenol Laboratories, Inc., Morton Grove, Ill.

Northup, SJ
Manager and associate director, Travenol Laboratories, Inc., Morton Grove, Ill.

Pages: 10    Published: Jan 1983

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Abstract

Four methods of in vitro biocompatibility screening using L-929 mouse fibroblast cells are discussed, namely, the fluid medium, agar diffusion, flask dilution, and flask dilution extraction methods. The range of test methods allows toxicity screening of both solid and liquid specimens and has been shown to provide good agreement with and better sensitivity than the United States Pharmacopeia (USP) rabbit muscle implantation assay. Approximately 2000 specimens are subjected to such in vitro evaluations annually at our facility for evaluating stability studies, component changes, formulations, and manufacturing processes. A scale of 0 to 4+ is used to indicate the extent of cellular damage providing a quantitation of toxic response.