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The experience of Eli Lilly and Co. has demonstrated that large-scale bioprocessing can be conducted under conditions that provide safety for the fermentation operator as well as the environment. Thirty years of medical surveillance of workers associated with large-scale bioprocessing has shown no increased incidence of morbidity or mortality associated with these processes. Over 100 000 h of experience with large-scale recombinant DNA fermentations has demonstrated that, with proper design and validation criteria, genetically engineered microorganisms can be developed and the operation scaled to efficient and economical processes with excellent protection to the environment and the operating personnel. Large-scale mammalian cell culture processes, which possess their own unique set of bio-safety issues, are being developed with safeguards that ensure the use of well-characterized cell lines, the inactivation of process streams, and the elimination of risk to the bioprocess operators.
bioprocessing, recombinant DNA fermentations, biosafety
Director, Fermentation Process Research and Development, Eli Lilly and Co., Indianapolis, IN