title: Airborne endotoxin associated with industrial-scale production of protein products in gram-negative bacteria.
abstract: Human and animal proteins of therapeutic value can be produced in E. coli, a gram-negative bacteria. Endotoxin, a cellular component, is reported to have clinically significant health effects. Operations--including culturing the microbe, separating solids by centrifugation, and mixing/homogenizing--had associated endotoxin levels ranging from 0.07 ng/m3 to 12.8 ng/m3. Utilizing a 10-fold safety factor under the threshold where clinically significant changes can be detected, an action level of 30 mg/m3 for large scale operations involving the use of E. coli was established. Operations conducted without engineering controls had maximum airborne endotoxin levels of 1812 ng/m3.
authors.affiliation: Genentech, Inc., South San Francisco, CA 94080.
authors.forename: R B
authors.initials: RB
authors.lastname: Palchak
authors.forename: R
authors.initials: R
authors.lastname: Cohen
authors.forename: M
authors.initials: M
authors.lastname: Ainslie
authors.forename: C L
authors.initials: CL
authors.lastname: Hoerner
mesh_terms: D000395:Air Pollutants, Occupational / Q000032:analysis*; D004731:Endotoxins / Q000009:adverse effects / Q000032:analysis*; D004781:Environmental Exposure; D006090:Gram-Negative Bacteria; D006801:Humans; D008452:Maximum Allowable Concentration; D015202:Protein Engineering
chemical_list: D000395:Air Pollutants, Occupational; D004731:Endotoxins