title: Endogenous microbial contamination of cultured autologous preparations in trials of cancer immunotherapy.
abstract: BACKGROUND
  Standardization of the manufacturing and processing of cellular immunotherapy products is necessary to ensure patient safety, establish efficacy, and demonstrate potency. Recognition of the autologous donor as a likely source of microbial contamination of cellular immunotherapy products may improve patient care and reduce expense to the laboratory.
  
  
  METHODS
  Data on 243 immunotherapy products manufactured in the authors' institution between December 1997 and June 2001 were retrospectively reviewed. Also reviewed were the case reports of four patients whose autologous immunotherapy products were contaminated.
  
  
  RESULTS
  Twenty-five (10%) of the 243 immunotherapy products processed were positive on one or more tests for microbial contamination. In six (24%) of the products, the source of microbial contamination was the autologous donor. In 17 of the remaining 19 products, test results were judged to be false-positive.
  
  
  CONCLUSIONS
  The unique processing techniques and stringent controls involved in the manufacture of cellular immunotherapy products may result in changes in the sources of microbial contamination routinely encountered. The identification of the autologous donor as a potential source of the microbial contamination of the product may assist the clinician and the laboratory in troubleshooting products with positive results on microbial sterility testing. Also, the number of false-positive results in this study indicates that further research is needed to maximize the specificity of testing while maintaining the present high sensitivity.
authors.affiliation: Division of Transfusion Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Padley
authors.forename: C W
authors.initials: CW
authors.lastname: Greiner
authors.forename: T L
authors.initials: TL
authors.lastname: Heddlesten
authors.forename: M K
authors.initials: MK
authors.lastname: Hopkins
authors.forename: M L
authors.initials: ML
authors.lastname: Maas
authors.forename: D A
authors.initials: DA
authors.lastname: Gastineau
mesh_terms: D000368:Aged; D002404:Catheterization / Q000009:adverse effects; D018929:Cell Culture Techniques / Q000379:methods; D002478:Cells, Cultured / Q000382:microbiology* / Q000637:transplantation*; D002986:Clinical Trials as Topic / Q000009:adverse effects; D004340:Drug Contamination / Q000517:prevention & control*; D005189:False Positive Reactions; D005260:Female; D006412:Hematopoietic Stem Cells / Q000382:microbiology; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D011786:Quality Control; D014182:Transplantation, Autologous / Q000009:adverse effects*