A Factor VIII Concentrate, Highly Purified and Heated in Solution

Heimburger, N.; Schwinn, Horst; P, Gratz; Kumpe, G.; Herchenhan, B.

doi:10.1159/000214550

Cited by 10 publications

(9 citation statements)

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“…Since the former Behringwerke AG introduced pasteurization in the 1980s (developed by Heimburger primarily for hemophilia products), no HIV transmission via the company's pasteurized products has occurred. [377][378][379] This pasteurization procedure has been adapted to Aventis Behring's plasma products, including C1-INH concentrate. The pasteurization procedure has been shown to have an excellent track record of virus safety, and the validity of the pasteurization for virus inactivation was confirmed in scientific articles.…”

Section: Treatment Of Aaementioning

confidence: 99%

Hereditary and acquired angioedema: Problems and progress: Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond

Agostoni¹,

Aygören‐Pürsün²,

Binkley³

et al. 2004

Journal of Allergy and Clinical Immunology

593

658

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Hereditary angioedema (HAE), a rare but life-threatening condition, manifests as acute attacks of facial, laryngeal, genital, or peripheral swelling or abdominal pain secondary to intra-abdominal edema. Resulting from mutations affecting C1 esterase inhibitor (C1-INH), inhibitor of the first complement system component, attacks are not histamine-mediated and do not respond to antihistamines or corticosteroids. Low awareness and resemblance to other disorders often delay diagnosis; despite availability of C1-INH replacement in some countries, no approved, safe acute attack therapy exists in the United States. The biennial C1 Esterase Inhibitor Deficiency Workshops resulted from a European initiative for better knowledge and treatment of HAE and related diseases. This supplement contains work presented at the third workshop and expanded content toward a definitive picture of angioedema in the absence of allergy. Most notably, it includes cumulative genetic investigations; multinational laboratory diagnosis recommendations; current pathogenesis hypotheses; suggested prophylaxis and acute attack treatment, including home treatment; future treatment options; and analysis of patient subpopulations, including pediatric patients and patients whose angioedema worsened during pregnancy or hormone administration. Causes and management of acquired angioedema and a new type of angioedema with normal C1-INH are also discussed. Collaborative patient and physician efforts, crucial in rare diseases, are emphasized. This supplement seeks to raise awareness and aid diagnosis of HAE, optimize treatment for all patients, and provide a platform for further research in this rare, partially understood disorder.

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Section: Treatment Of Aaementioning

confidence: 99%

Hereditary and acquired angioedema: Problems and progress: Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond

Agostoni¹,

Aygören‐Pürsün²,

Binkley³

et al. 2004

Journal of Allergy and Clinical Immunology

593

658

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“…A series of effectively virus-inactivated plasma deriv atives are presently available to treat volume deficiency, inherited and acquired deficiencies of coagulation factors and inhibitors as well as immunoglobulin deficiencies [1], Several procedures for virucidal treatment of plasma de rivatives have been described, including heating in the lyophilized state [2], wet heating (pasteurization) [3][4][5], heating with hot vapour [6], treatment with beta-propiolactone and ultraviolet irradiation [7], and treatment with the organic solvent tri(n-butyl)phosphate (TNBP) in combination with a detergent [8,9], These have recently been reviewed [10][11][12]. In combination with careful donor selection and donor blood screening, these procedures reduce the risk of transmitting virus diseases by plasma derivatives to a very low level.…”

mentioning

confidence: 99%

Manufacture and in vitro Characterization of a Solvent/Detergent-Treated Human Plasma

Hellstern¹,

Sachse²,

Schwinn³

et al. 1992

Vox Sanguinis

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We have developed a modified solvent/detergent (S/D) treatment to inactivate viruses in human plasma using 1% w/w final concentrations of tri(n-butyl) phosphate (TNBP) and Triton X-100 and an incubation period of 4 h at 30°C. The procedure inactivates ≥10^6 chimpanzee-infectious doses (CID(50)) of HBV, ≥10^5 CID(50) of HCV. and ≥10^6 tissue culture infectious doses (TCID(50)) of HIV. After virus inactivation, eleven plasma batches were lyophilized and 12 batches were deep-frozen until further use. The batches were characterized by extensive laboratory tests including measurement of clotting factors I—XIII. von Willebrand factor, plasminogen, inhibitors of blood coagulation and fibrinolysis, and other clinically important plasma proteins. All parameters were determined before and after S/D treatment. Twelve conventional single donor plasma units served as control. There were no marked losses of activities of clotting factors, antithrombin III, protein C. plasminogen, and Cl-esterase inhibitor due to treatment. After the S/D step, the levels of these parameters were within the normal range in all batches. The same holds true for total protein, immunoglobulins, albumin, complement factors C3 and C4, haptoglobin, hemopexin, caeruloplasmin, α(1)-antitrypsin, and pH. Protein S and α(2)-antiplasmin activites decreased by about 50% and were frequently found to be slightly below the lower limit of the respective normal range after treatment. The interindividual variations of all proteins analysed were significantly lower than in the single donor plasma units. The S/D procedure did not lead to increases of markers indicating activation of hemostasis. We conclude that lipid-enveloped viruses can be inactivated by the S/D procedure described in this study without critical reduction of recoveries of plasma proteins.

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“…Since methods are now available for testing sera for the presence of aiiti HIV antibodies, and, furtherinore, rather mild procedures for inactivating the virus have been established (18), vendors shoüld be obliged to provide control and calibration materials which are anti HIV antibody-üegative, in order to lower the potential risk for laboratory personnel.…”

Section: Discussionmentioning

confidence: 99%

Incidence of Anti HIV Antibodies and Viral Antigen in Standard and Control sera

Köller¹,

Rumpold²,

Schindler³

et al. 1987

Clinical Chemistry and Laboratory Medicine

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Summary:Most material used for control and calibration in a clinical laboratory is based on pool sera of human origin, guaranteed to be HBsAg-free. Since little Information is available on the potential infectivity of HIV, the causative agent of acquired immunodeficiency syndrome (AIDS), 54 control and calibration sera, in routine use, were investigated for the incidence of antibodies to HIV by means of Elisa. Sixteen test specimens (= 30%) gave positive or borderline Elisa results and were further analysed by immunoblotting, resulting in 15 samples all recognizing gp 160 and partially the p 24, p 31, p 55, p 64 and gp 120 band. Only one sample with borderline Elisa result was negative by this assay. Furthermore, all sera were examined for the presence of viral antigen by a solid phase Elisa. All samples under investigation gave negative antigen Elisa results. Bearing in miiid that the sensitivity of this assay is limited to 10 g/l of viral antigen, no conclusion on infectivity should be drawn. The high incidence of HlV-antibodies in the sera investigated demands that this material should be handled with special care by laboratory personnel.

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A Factor VIII Concentrate, Highly Purified and Heated in Solution

Cited by 10 publications

References 0 publications

Hereditary and acquired angioedema: Problems and progress: Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond

Hereditary and acquired angioedema: Problems and progress: Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond

Manufacture and in vitro Characterization of a Solvent/Detergent-Treated Human Plasma

Incidence of Anti HIV Antibodies and Viral Antigen in Standard and Control sera

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