Recovery of Australia Antigen from Human Plasma
Products Separated by a Modified Cohn Fractionation

Berg, Rebekka; Björling, H.; Berntsen, K.; Espmark, Å.

doi:10.1159/000464479

Cited by 6 publications

(12 citation statements)

References 7 publications

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“…Even the most sensitive tests [2,4] did not detect thrombin nor HBAg. The HBAb content was higher than that of the normal immunoglobulin con-centrâtes, which have been reported not to transmit serum hepatitis [1]. In our attempts to achieve a further increase in the yield of anti-D and other antibodies, it will be necessary to develop fractionation techniques, which will allow a better separation between the antibodies and, especially, unstable proteins, such as a2-lipoprotein causing problems in filtration and fibrinogen causing turbidity during storage.…”

Section: Discussionmentioning

confidence: 91%

“…Pro(thrombin) and HBAg, which normally may occur in fraction III [1,3] may be present to some extent in its immunoglobulin concentrates. Even the most sensitive tests [2,4] did not detect thrombin nor HBAg.…”

Section: Discussionmentioning

confidence: 99%

“…The quality of the obtained concentrate was compared to that of the con centrate processed in the usual way. Since fraction III may contain (pro) thrombin [3] or hepatitis B antigen (HBAg) [1] the concentrate was analysed for the presence of both components, to eliminate the risks of blood coagula tion and transmission of serum hepatitis.…”

Section: Introductionmentioning

confidence: 99%

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Contributions to the Optimal Use of Human Blood

Vogelaar¹,

Berg²,

Reijnierse³

et al. 1974

Vox Sanguinis

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It was observed that during the preparation of normal anti-D immunoglobulin concentrates by a modified Cohn VI method a considerable loss of anti-D activity occurred in fraction III. A method was developed to prepare anti-D immunoglobulin concentrates from fraction III by ethanol fractionation. Three batches were treated on a production scale. An average of 18% of the amount of anti-D activity present in the original plasma, was recovered, which increased the total yield of anti-D activity from 44 to 62%. The specific activity of anti-D in the concentrate thus prepared was 2-3 times higher than that in the normal anti-D immunoglobulin concentrate. The anti-D immunoglobulin concentrate prepared from fraction III was diluted with normal immunoglobulin concentrate to reach an anti-D concentration of 110-120 µg/ml. Using several analytical procedures no essential differences could be demonstrated between this final product and the normal immunoglobulin concentrate. After 8 months of storage at 4°C no significant decrease in anti-D activity could be demonstrated.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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Contributions to the Optimal Use of Human Blood

Vogelaar¹,

Berg²,

Reijnierse³

et al. 1974

Vox Sanguinis

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“…The fractionation procedure employed has been described in detail previously [1,3], A schematic outline, which also includes the numbering of the samples relevant for HB Ab testing, is given in figure 1.…”

Section: Methodsmentioning

confidence: 99%

“…This work is a counterpart to our previous analysis of the fractions obtained from HBAg-containing plasma [1],…”

Section: Introductionmentioning

confidence: 90%

Recovery of Hepatitis B Antibody from Human Plasma Products Separated by a Modified Cohn Fractionation

Berg¹,

Berntsen²,

Björling³

et al. 1974

Vox Sanguinis

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Hepatitis B immune globulin has been prepared for clinical trials in Sweden. The relative amount of antibodies to the hepatitis B antigen recovered in the respective fractionation steps was evaluated by hemagglutination, immunoelectro-osmophoresis and radial immunodiffusion. About one third of the antibody amount present in the original plasma pool was recovered in fraction II. Hepatitis B antigen was neither demonstrated in the various fractionation steps nor in the final immune globulin preparation.

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The viral safety of intravenous immune globulin

Yap

1996

Clinical and Experimental Immunology

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The viral safety of intravenous immune globulin (IVIG) preparations has been investigated since 1983 when it was discovered that non‐A, non‐B hepatitis (NANBH) could be transmitted by an experimental IVIG preparation. Recently, it has been demonstrated that the virus causing NANBH is the hepatitis C virus (HCV). A number of subsequent episodes of HCV transmission by IVIG have been reported, but not all the factors that have led to this transmission arc clearly understood. However, based on two episodes of HCV transmission by anti‐D immune globulin (formulated for intravenous administration), it appears that cold ethanol fractionation is important in ensuring viral safety because both of the implicated anti‐D immune globulin preparations were manufactured without cold ethanol fractionation. Other HCV transmission episodes have been associated with chromatography (particularly DEAE‐Sephadcx chromatography) as a separation step carried out to further purify IgG, after cold ethanol fractionation, and it is possible that such a procedure has only a marginal partitioning capacity for infective HCV virions. The role of anti‐HCV screening in improving the viral safety of IVIG preparations remains unclear, but a recent transmission episode by a previously safe IVIG preparation suggests that the absence of anti‐HCV antibodies during plasma fractionation may affect the partitioning characteristics of HCV and may also cause a loss of neutralizing antibody against HCV. All of the IVIG preparations associated with HCV transmission have been formulated as freeze‐dried preparations and this may have been important in stabilizing HCV during the period prior to administration to patients. No other viruses appear to have been transmitted by IVIG preparations, but prior to seroconversion, HCV‐infected plasma donors may continue to contaminate plasma pools used for the manufacture of blood products, despite anti‐HCV screening, and additional viral inactivation steps such as incubation at pH4 or solvent‐detergent treatment should be incorporated into the production process of all IVIG preparations.

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Recovery of Australia Antigen from Human Plasma Products Separated by a Modified Cohn Fractionation

Cited by 6 publications

References 7 publications

Contributions to the Optimal Use of Human Blood

Contributions to the Optimal Use of Human Blood

Recovery of Hepatitis B Antibody from Human Plasma Products Separated by a Modified Cohn Fractionation

The viral safety of intravenous immune globulin

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