Validation of the heat treatment step used in the production of diaspirin crosslinked hemoglobin (DCLHb™) for viral inactivation

被引:7
作者
Azari, M [1 ]
Ebeling, A
Baker, R
Burhop, K
Camacho, T
Estep, T
Guzder, S
Marshall, T
Rohn, K
Sarajari, R
Boose, JA
Gauvin, G
Horner, R
Lu, B
Pearson, L
Vacante, D
机构
[1] Baxter Healthcare Corp, Blood Substitutes Program, Round Lake, IL 60073 USA
[2] Microbiol Assoc Inc, Proc Validat Div, Rockville, MD 20850 USA
来源
ARTIFICIAL CELLS BLOOD SUBSTITUTES AND IMMOBILIZATION BIOTECHNOLOGY | 1998年 / 26卷 / 5-6期
关键词
D O I
10.3109/10731199809117477
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
A series of experiments was performed to assess the ability of the heat treatment step used in the manufacture of diaspirin crosslinked hemoglobin (DCLHb(TM)) to inactivate viruses. In-process solutions (reaction mixtures after the crosslinking process) atom six different manufacturing lots were used as test media in a 1:680 scaled down system in which the key process parameters used in the large scale production were duplicated. The inactivation of five different viruses (Bovine Viral Diarrhea Virus, Pseudorabies Virus, Human Immunodeficiency Virus 1, Porcine Parvovirus and Hepatitis A Virus) was evaluated. Each validation experiment consisted of spiking the solution at 37 degrees C with virus, heating to 74 +/- 1 degrees C over a period of 30 minutes, holding at 74 +/- 1 degrees C for 90 minutes and cooling from 74 +/- 1 degrees C to less than 10 degrees C over a period of 30 minutes. Duplicate experiments were performed with each of the viruses with the exception of Human Immunodeficiency Virus 1, for which three experiments were performed. In each experiment samples were removed before, during, and after heating for the purpose of determining virus titer and evaluating key process parameters. The results obtained from these experiments confirmed that the key process parameters in these experiments using the sealed down test system reproduced those of the large scale manufacturing process. The results of the virus assays showed at least a 7 log reduction was accomplished by the heat treatment for each of the viruses tested.
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页码:577 / 582
页数:6
相关论文
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