Experience in cell line testing.

Abstract

For more than ten years Microbiological Associates, Inc. has provided testing services for cell lines, products and processes associated with the safety of recombinant biologics. The results of numerous cell line characterizations performed under the guidance of "Points to Consider" documents shed light on the incidence of contamination of production cell banks. The most common sources of compromise of production substrates are also identified. Findings from this short review, though necessarily general, permit attention to be focused on areas of cell line characterization where concern is warranted. Conversely, where an alternative technique of equal sensitivity to existing tests is available for specific cell substrates, these may be given consideration. The observations presented here support the overall safety of biopharmaceuticals produced from genetically engineered cell lines and the wisdom of a multifaceted approach to assure product safety.