Investigation of prion removal/inactivation from chromatographic gel

Abstract

A model system for assessment of prion inactivation/removal from chromatography gels has been established. Spiked prion infectivity does bind to DEAE Sepharose gel; however, the cleaning cycle removed infectivity to levels below that detectable by bioassay.

Prion‐removal capacity of chromatographic and ethanol precipitation steps used in the production of albumin and immunoglobulins

“…In our study, new chromatography gels were used, as opposed to production gels that had been exposed to previous cycles. The possibility of infectivity binding to chromatography gels has led to further experimental work examining prion removal and or inactivation of infectivity from chromatography gels, in which it was ascertained that infectious prions did bind to DEAE Sepharose, and the cleaning cycle was able to remove or inactivate this infectivity [32].…”

Decontamination of prions in a plasma product manufacturing environment

“…To ensure adequate batch‐to‐batch safety, cleaning procedures must be individually evaluated to guarantee prion removal and/or inactivation from chromatographic equipment including gels. Thyer and colleagues investigated the removal and/or inactivation of scrapie ME7 prions from DEAE Sepharose resins in a 2‐mL column model showing an RF of more than 2.75 log. However, their study was limited to one type of gel (anion‐exchange chromatography) and was performed in an experimental system rather than a true scale‐down of the industrial chromatography.…”

Pathogen safety of human C1 esterase inhibitor concentrate

“…The routine cleaning and sanitization procedures implemented in the manufacturing process for C1‐INH according to GMP requirements effectively inactivate and/or remove viruses and prions that might be present in equipment and material, 23,27‐35 resulting in effective batch‐to‐batch segregation. The efficacy of sanitization by NaOH regarding viruses and prions was also demonstrated for the HIC in the experiments presented.…”

“…This stated that a prion reduction factor of 4 log to 6 log (or more) will result in a very low risk of vCJD infection due to the application of such plasma-derived coagulation factor concentrates. 26 The routine cleaning and sanitization procedures implemented in the manufacturing process for C1-INH according to GMP requirements effectively inactivate and/or remove viruses and prions that might be present in equipment and material, 23,[27][28][29][30][31][32][33][34][35] resulting in effective batchto-batch segregation. The efficacy of sanitization by NaOH regarding viruses and prions was also demonstrated for the HIC in the experiments presented.…”