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Published online 2017 Nov 16.
doi: 10.1111/trf.14390
Albrecht Gröner, 1 Connie Broumis, 2 Randel Fang, 2 Thomas Nowak, 1 Birgit Popp, 1Wolfram Schäfer, 1 and Nathan J. Roth3
Abstract
BACKGROUND
Careful selection and testing of plasma reduces the risk of blood‐borne viruses in the starting material for plasma‐derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood‐borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment.
STUDY DESIGN AND METHODS
The virus inactivation kinetics of pasteurization for a broad range of viruses were evaluated in the relevant intermediates from more than 15 different plasma manufacturing processes. Studies were carried out under the routine manufacturing target variables, such as temperature and product‐specific stabilizer composition. Additional studies were also performed under robustness conditions, that is, outside production specifications.
RESULTS
The data demonstrate that pasteurization inactivates a wide range of enveloped and nonenveloped viruses of diverse physicochemical characteristics. After a maximum of 6 hours' incubation, no residual infectivity could be detected for the majority of enveloped viruses. Effective inactivation of a range of nonenveloped viruses, with the exception of nonhuman parvoviruses, was documented.
CONCLUSION
Pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against known blood‐borne pathogens and emerging or potentially emerging viruses. Pasteurization has proven itself to be a highly effective step, in combination with other complementary safety measures, toward assuring the virus safety of final product.
... The following viruses and respective cell lines (Table S1, available as supporting information in the online version of this paper) were used in the pasteurization studies: human parvovirus B19 (B19V), UT7/epo‐S1; bovine herpesvirus 1 (BoHV‐1), FROv; bovine viral diarrhea virus (BVDV), FROv/BT; canine parvovirus (CPV), CrFK/KL; duck HBV (DHBV), ducklings and in vitro; encephalomyocarditis virus (EMCV), Vero; equine herpesvirus 1 (EHV‐1), Vero; herpes simplex virus (HSV‐1), PH‐2; pandemic swine influenza virus (H1N1); highly pathogenic avian influenza virus (H5N1), MDCK; hepatitis A virus (HAV), RhK/BSC‐1; human herpesvirus 5 (HHV‐5), MRC5; HIV, Jurkat/MT‐4/C8166; La Crosse virus (LACV), Vero 1008; minute virus of mice (MVM), A9; pseudorabies virus (PRV), PH‐2/Vero; SARS coronavirus (SARS‐CoV), Vero E6; Semliki Forest virus (SFV), PH‐2; Sindbis virus (SINV), PH‐2; tick‐borne encephalitis (TBEV), A549; transmissible gastroenteritis coronavirus (TGEV), FSHo; West Nile virus (WNV), PH‐2; Yellow Fever virus (YFV), PH‐2; and Zika virus (ZIKV), PH‐2. ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7169671/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7169671/
doi: 10.1111/trf.14390
Albrecht Gröner, 1 Connie Broumis, 2 Randel Fang, 2 Thomas Nowak, 1 Birgit Popp, 1Wolfram Schäfer, 1 and Nathan J. Roth3
Abstract
BACKGROUND
Careful selection and testing of plasma reduces the risk of blood‐borne viruses in the starting material for plasma‐derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood‐borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment.
STUDY DESIGN AND METHODS
The virus inactivation kinetics of pasteurization for a broad range of viruses were evaluated in the relevant intermediates from more than 15 different plasma manufacturing processes. Studies were carried out under the routine manufacturing target variables, such as temperature and product‐specific stabilizer composition. Additional studies were also performed under robustness conditions, that is, outside production specifications.
RESULTS
The data demonstrate that pasteurization inactivates a wide range of enveloped and nonenveloped viruses of diverse physicochemical characteristics. After a maximum of 6 hours' incubation, no residual infectivity could be detected for the majority of enveloped viruses. Effective inactivation of a range of nonenveloped viruses, with the exception of nonhuman parvoviruses, was documented.
CONCLUSION
Pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against known blood‐borne pathogens and emerging or potentially emerging viruses. Pasteurization has proven itself to be a highly effective step, in combination with other complementary safety measures, toward assuring the virus safety of final product.
... The following viruses and respective cell lines (Table S1, available as supporting information in the online version of this paper) were used in the pasteurization studies: human parvovirus B19 (B19V), UT7/epo‐S1; bovine herpesvirus 1 (BoHV‐1), FROv; bovine viral diarrhea virus (BVDV), FROv/BT; canine parvovirus (CPV), CrFK/KL; duck HBV (DHBV), ducklings and in vitro; encephalomyocarditis virus (EMCV), Vero; equine herpesvirus 1 (EHV‐1), Vero; herpes simplex virus (HSV‐1), PH‐2; pandemic swine influenza virus (H1N1); highly pathogenic avian influenza virus (H5N1), MDCK; hepatitis A virus (HAV), RhK/BSC‐1; human herpesvirus 5 (HHV‐5), MRC5; HIV, Jurkat/MT‐4/C8166; La Crosse virus (LACV), Vero 1008; minute virus of mice (MVM), A9; pseudorabies virus (PRV), PH‐2/Vero; SARS coronavirus (SARS‐CoV), Vero E6; Semliki Forest virus (SFV), PH‐2; Sindbis virus (SINV), PH‐2; tick‐borne encephalitis (TBEV), A549; transmissible gastroenteritis coronavirus (TGEV), FSHo; West Nile virus (WNV), PH‐2; Yellow Fever virus (YFV), PH‐2; and Zika virus (ZIKV), PH‐2. ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7169671/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7169671/