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Cutter and Alpha both published the results of tests which showed that their heating processes had inactivated HTLV-3/HIV virus load to a degree sufficient to show they were almost certainly (generally) safe, and the use of heat-treated product had been strongly endorsed by "The Lancet".

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Dr Snape wrote to the haemophilia centre directors to inform them that "limited supplies" of a heated Factor 8 concentrate would be available in early February and that would be "the product generally available for the next three to four months, the amounts being 50-60% of what would otherwise have been supplied as unheated concentrate."

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BPL had started to heat treat its Factor 8 and "limited amounts will be distributed to the National Health Service for clinical trials within the next two weeks. Heat-treatment capacity is being increased, and it is hoped that, by April this year, all BPL factor VIII will be heat-treated."

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Dr Snape wrote to Dr Lane: "a significant number of HTLV-III Christmas disease patients, treated only with NHS IX and with no other risk factors, argues strongly for haste with manufacture of heated factor IX."

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BPL were in a position to issue information sheets which stated that the clinical trials of 8Y at six haemophilia centres showed that several patients had by then safely passed the point at which the first evidence of non-A non-B Hepatitis viral transmission would normally occur with non-heated Factor 8.

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BPL and PFC recalled unheated Factor 9 in October 1985.

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Dr Harris of Armour wrote to haemophilia centre directors recommending the return of all non-donor tested Factorate so that it could be exchanged for material manufactured from screened donations.

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An internal Cutter memo showed that all heat-treated product made commercially carried a significant, though reduced, risk of hepatitis. None had been eliminated.

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The Committee on Safety of Medicines considered the safety of heat-treated Factor 8.

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Dr Peter Fernandes accidently discovered an appropriate stabiliser and by December 1978 had moved on to show those which worked with the globulin could work with antihaemophilic factor.

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Behringwerke conducted initial experiments in heat treatment.

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Dr Milton Mozen, director of biochemical research and development at Cutter, said that "Concern about hepatitis transmission" was the reason for experiments with heat treatment in the early 1970s.

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David Castaldi from Hyland sent a memo to his distribution team about the decision to proceed with heat treating its product, on the basis not that it would eliminate hepatitis, but reduce the risk of it.

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Dr Shanbrom stated that he tried to persuade the four major manufacturers of factor concentrates to use a detergent process for viral inaction in the mid to late 1970s.

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Bruce L Evatt from the Center for Infectious Diseases wrote to Fred Feldman, Armour Pharmaceuticals regarding heat inactivation of LAV in clotting concentrates and two preliminary experiments that had been undertaken with regards to this.

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UK haemophilia reference centre directors sent a circular letter to all haemophilia centres with recommendations on choice on therapeutic products for the treatment of non-inhibitor patients with Haemophilia A, Haemophilia B or von Willebrand's Disease.

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Chiron Corporation identified, cloned and expressed proteins from Hepatitis non-A non-B virus, which may allow screening for previously undetectable disease.

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In the draft witness statement of Dr Snape, he stated that between May and October 1984 activities leading to the establishment of the 8Y process "began in earnest".

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All issues of Factor 8 were subjected to HT3 heat treatment. The product which was coded 8Y was made at both Oxford and Elstree.

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From May 1985, all Factor 8 issues by BPL/PFL had been heat treated under at least HT2 conditions.

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