Possible removal of prion agents from blood products during the manufacturing process

Author:

Yunoki Mikihiro1,Urayama Takeru1,Ikuta Kazuyoshi2

Affiliation:

1. Infectious Pathogen Research Group, Hirakata Research Laboratory, Research & Development Division, Benesis Corporation, 2-25-1, Shodai-ohtani, Hirakata, Osaka 573-1153, Japan.

2. Research Institute for Microbial Diseases, Department of Virology, Osaka University, Suita, Osaka 565-0871, Japan.

Abstract

Blood products prepared from human blood theoretically risk contamination with infectious pathogens. Since recent reports now confirm the likely transmission of pathogenic prions through blood transfusion, effective measures to prevent transmission are required globally, although the prevalence of variant Creutzfeldt–Jakob disease outside of the UK is extremely low. Many studies evaluating the manufacturing process have been conducted for the potential removal of the prion protein from plasma derivatives. In this review, we discuss the possibility of removing prions via several processing steps, especially depth and virus-removal filtration. Through a discussion of the limitations and issues associated with such studies, we hope our review will be of help for better study design in the future.

Publisher

Future Medicine Ltd

Subject

Virology

Reference56 articles.

1. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion

2. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient

3. Fears grow as blood stocks pass on prions undetected

4. Strengthening of Quality and Safety Assurance of Drugs and Medical Devices Manufactured Using Components of Human Origin as Raw Materials, PFSB Notification No.0209003 dated February 9, 2005, Ministry of Health, Labour and Welfare, Japan (In Japanese).

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