The Case for Heat-Treated Products

Allain, Jean Paul; Masson, Pierre; Dolkart, R.E.

doi:10.1016/s0140-6736(85)91467-9

Cited by 7 publications

(3 citation statements)

References 2 publications

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“…In preliminary wet heat-treatm ent studies of the M ethod II product (60 °C for 10 h in the presence of high concentrations of glycine and sucrose) only 65 ± 8% recovery of V III :C was observed in comparison (experim ents not presented). Though the impact of dry heat-treatm ent on neoantigen exposure was not assessed in the present study, other reports have indicated th at there is no evidence this occurs w hether determ ined by in vitro analyses (8,(31)(32)(33) or after clinical evaluation in animals o r hemophilia A patients (8,32,(34)(35)(36). The inactivation of lipidcoated viruses in plasma products by detergent treatm ent has been previously shown to be an effective m ethod of viral inactivation while perm itting good recovery of activity (37)(38)(39)(40).…”

Section: Discussionmentioning

confidence: 79%

Development of a Heat-Treated Factor VIII/ von Willebrand Factor Concentrate Prepared from Heparinized Plasma

et al. 1990

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SummaryA high yield, intermediate purity factor VIII concentrate derived from heparinized plasma has been developed which can be heat-treated at 60 °C, 68 °C or 80 °C/72 h to permit inactivation of viral contaminants which may be present. After cold reprecipitation of the heparinized cryoprecipitate (CRC), the resolubilized CRC precipitate was adjusted to 25-30 mg/ml protein and pH 6.35 ± 0.1 and incubated for 1 h at 8 °C. After centrifugation to remove the precipitated fibrinogen and fibronectin, a factor VIII-rich supernatant can be recovered which contains > 500 units of VIII : C per liter of starting plasma (Method I product) at a purity of 1.5 U/mg protein. Adjusted to 50 mM glycine and pH 6.8, the product can be lyophilized and heat-treated at 60 °C/72 h without a significant loss of VIII :C activity. However, at 68 °C or 80 °C/72 h, temperatures now reported to be more effective in viral inactivation, the recoveries were reduced to 68 and 33% respectively. Significantly improved recoveries after heat-treatment (HT) at 68 °C or 80 °C/72 h were achieved if the 8 °C supernatant product was prepared by a modified procedure (Method II). This further reduces the fibrinogen content of the product while maintaining VIII : C yields > 500 U/l at a purity of 1.9 U/mg. When adjusted to 50 mM glycine and 1-2% (w/v) sucrose (pH 6.8), lyophilized and heat treated at 60 °C, 68 °C or 80 °C/72 h, the VIII :C recoveries of Method II product were 88-100%, 79-84% and 80-83% of pre-HT levels respectively. The yield of VIII : C was > 400 U/l at a purity of 1.6-1.4 U/mg at 1-2% (w/v) sucrose even after the severe heat-treatment at 80 °C. In addition, the von Willebrand factor multimers are similar in size and triplet pattern to those observed in routine cryoprecipitate preparations.

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Section: Discussionmentioning

confidence: 79%

Development of a Heat-Treated Factor VIII/ von Willebrand Factor Concentrate Prepared from Heparinized Plasma

et al. 1990

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“…The considerable, but uncoordinated, efforts of the group supported by the Ministry of Industry and Research (MIR) [1–8], the groups based at the Cochin Hospital [9] and at the Pasteur Institute [10–18] slowly gathered the necessary information regarding numerous questions at issue: what was the cause of the decrease of CD4 T cells observed in asymptomatic patients [9,12]? Was it related to the purity of therapeutic products or to a hypothetical virus [6,7]? Were these disturbances related to therapeutic products imported from the USA (where AIDS had first been recognized) or was it also related to products derived from the French plasma [7]?…”

mentioning

confidence: 99%

“…What was the evidence that the first viral inactivation methods (proven inefficient on hepatitis B virus and the putative agent of non‐A‐non‐B hepatitis) were active on LAV [17]? Was the fear of inhibitors to factor (F)VIII related to heat‐treatment‐induced neoantigens real [6]? What was the clinical value of the prototype assays to detect antibodies to LAV/HTLV‐III [14,16,18]?…”

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confidence: 99%

AIDS, hepatitis and hemophilia

2004

Journal of Thrombosis and Haemostasis

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Hemostatic effect of a heat-treated factor VIII concentrate (Haemate P) in von Willebrand's disease

Fukui

Nishino

Terada

et al. 1988

Blut

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A heat-treated factor VIII (F VIII) concentrate (Haemate P) has been administered to patients with various types of von Willebrand's disease (vWD). The 4 activities of F VIII/vWF as well as change in the multimeric structure of vWF were then studied. In 4 patients with type I vWF who were given a Ristocetin cofactor (Rcof) dose of 42-78 U/kg, there was a clear reduction of the bleeding time and an increase of F VIII: C, F VIII: Ag, Rcof and vWF: Ag for several hours. The recovery of Rcof. after 1 h was 50-75%. Although the multimeric composition of vWF in these patients was similar to that of normal plasma, the density of each multimer band was very low. After infusion, however, the density of all multimer bands increased for several hours, to decrease again after 24 h. In 4 patients with type II A vWD who received a dose of Rcof of 55-76 U/kg, the 4 activities of F VIII/vWF increased similarly as was the case in type I. All patients had only 3-4 smaller multimer bands. New larger and intermediate multimers appeared for several hours after infusion of the preparation. Two patients with type III vWD who received doses of Rcof of 52 and 65 U/kg showed also a similar increase in the 4 activities of F VIII/vWF after infusion. All the multimers lacking in these patients appeared for several hours after infusion.

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The Case for Heat-Treated Products

Cited by 7 publications

References 2 publications

Development of a Heat-Treated Factor VIII/ von Willebrand Factor Concentrate Prepared from Heparinized Plasma

Development of a Heat-Treated Factor VIII/ von Willebrand Factor Concentrate Prepared from Heparinized Plasma

AIDS, hepatitis and hemophilia

Hemostatic effect of a heat-treated factor VIII concentrate (Haemate P) in von Willebrand's disease

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