DEVELOPMENT OF A PRE-SCREENING METHOD FOR BDTBPP, A CYTOTOXIC LEACHABLE FROM SINGLE-USE BIOPROCESSING CONTAINERS.

摘要

Extractable and leachable compounds are a major obstacle in the implementation of single-use technologies. Recent studies show that a widely used trisarylphosphite-based processing stabilizer in plastic films, Irgafos 168?, can breakdown from gamma irradiation. One of the breakdown compounds, bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) has been found to leach out of single-use containers and suppress CHO cell growth. Due to its cytotoxic effect on bioprocessing cell lines, a targeted test for bDtBPP would be highly beneficial for pre-screening single-use bioprocessing containers and bags.