This work was supported by the “Global Platform of Decontamination” project, funded in part by the French State.
Decontamination of prions in a plasma product manufacturing environment
Version of Record online: 27 AUG 2013
© 2013 American Association of Blood Banks
Volume 54, Issue 4, pages 1028–1036, April 2014
How to Cite
Bellon, A., Comoy, E., Simoneau, S., Mornac, S., Dehen, C., Perrin, A., Arzel, A., Arrabal, S., Baron, H., Laude, H., You, B., Deslys, J.-P. and Flan, B. (2014), Decontamination of prions in a plasma product manufacturing environment. Transfusion, 54: 1028–1036. doi: 10.1111/trf.12381
- Issue online: 11 APR 2014
- Version of Record online: 27 AUG 2013
- Manuscript Accepted: 9 JUL 2013
- Manuscript Revised: 8 JUL 2013
- Manuscript Received: 28 MAY 2013
- French State
The high resistance of prions to inactivating treatments requires the proper management of decontaminating procedures of equipment in contact with materials of human or animal origin destined for medical purposes. Sodium hydroxide (NaOH) is widely used today for this purpose as it inactivates a wide variety of pathogens including prions.
Study Design and Methods
Several NaOH treatments were tested on prions bound to either stainless steel or chromatographic resins in industrial conditions with multiple prion strains.
Data show a strong correlation between inactivation results obtained by immunochemical detection of the prion protein and those obtained with infectivity assays and establish effective inactivation treatments for prions bound to stainless steel or chromatographic resins (ion exchange and affinity), including treatments with lower NaOH concentrations. Furthermore, no obvious strain-specific behavior difference was observed between experimental models.
The results generated by these investigations show that industrial NaOH decontamination regimens (in combination with the NaCl elution in the case of the chromatography process) attain substantial prion inactivation and/or removal between batches, thus providing added assurance to the biologic safety of the final plasma-derived medicinal products.