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In his report of his visit to plasmapheresis centres, Dr Peter Jones commented that: "It is imperative that the Revlon Health Care Group [which owned Armour] became totally self-sufficient in terms of source plasma."
Published on:
27 August, 2024
Armour published Plasma Perspectives No 1 which referred to Factorate being manufactured from pools of "only approximately 2,000 donors." It is not clear if this is a less precise formulation of the same idea, or whether it reflects an increase in the size of the plasma pools between the mid 1970s and 1981.
Published on:
27 August, 2024
Armour stated that: "Plasma Alliance's [the plasma collection company affiliated with Armour] 22 centres are responsible for collecting from approximately 22,000 donors registered at any one time." Annually, over one million plasma donations were processed. It follows that a patient receiving a single infusion of Factorate in the later 1970s would be exposed to somewhere in the region of 1,540 donations.
Published on:
27 August, 2024
Dr Michael Rodell sent a telex to W Tarbit which showed that self-sufficiency, at least for Factorate, had been achieved by June 1983.
Published on:
27 August, 2024
W Tarbit sent a telex to Dr Rodell suggesting that Armour might still, on occasion, be reliant on external purchases. It seems that this may have been a provisional view expressed by the officers of the UK subsidiary before the definitive answer was received from Dr Rodell of the US parent company.
Published on:
27 August, 2024
H L Shaw sent a telex to Kas Egerton contributing to the provisional view that Armour might still, on occasion, be reliant on external purchases, before the definitive answer was received from Dr Rodell of the US parent company:
Published on:
27 August, 2024
Dr Thomas Cleghorn stated in an interview that he had been told that from November 1975 only plasma from the mainland US would be used.
Published on:
27 August, 2024
Dr Jones drafted a memo describing the circumstances in which he was invited by Armour to inspect and report on facilities supplying Armour with plasma through its subsidiary company, Plasma Alliance.
Published on:
27 August, 2024
Immuno employed a system of "Neutral texts" (wording that could be used in any countries where there was no requirement for a specific formulation, including for unlicensed products in the UK) and "UK specific texts" which had the approval of the UK licensing authority and had to be used for a licensed product.
Published on:
27 August, 2024
C Chard wrote a memo to G Hardy providing evidence that plasma from outside the US and Europe was still being "routinely" used in the production of albumin products at its facility in Lessines, Belgium, that those products were imported to the UK, and that this was in contravention of the product licence that specified the use of US plasma.
Published on:
27 August, 2024
Hyland targeted gay men for whole blood donations for the purpose of obtaining hyperimmunised plasma, and while Hyland did not use plasma recovered following this process for its own factor concentrates it did sell this on to Alpha, and Alpha then used that plasma as part of its pools when manufacturing factor concentrates.
Published on:
27 August, 2024
Edward Harriman witnessed how brisk business was being done obtaining cheap plasma from the riskiest of sources, for onward sale, though he did not see for himself any evidence of to whom that sale was being made.
Published on:
27 August, 2024
Ed Harriman wrote an article in New Scientist noting that "Not surprisingly, Dr Z F Hantchef, head of the Red Cross's Blood Transfusion Service in Geneva, hotly denies Ramos's claim. For years, he has been speaking out against unscrupulous dealers."
Published on:
27 August, 2024
Three prison centres were included in a list of plasma sources in a document that was compiled as part of a UK product licence application for Koate. These were Arizona State Prison, the Southern Desert Correctional Center and the Northern Nevada Correction Center.
Published on:
27 August, 2024
Dr Thomas referred to pools of 6,000 donors in his 1972 report on Hyland facilities, which was considered as part of the Hemofil product licence application.
Published on:
27 August, 2024
A 25-page FDA instruction booklet was published setting out in detail the matters to be inspected prior to product licensing, including the requirements for donor identification and consent, the medical examination of donors, the process of obtaining plasma, record keeping, plasma separation and pooling following donations, the equipment used for plasmapheresis, testing for Hepatitis B surface antigen, (and) product labelling,.
Published on:
18 October, 2024
Dr John Petricciani wrote to Dr Steven Ojala evidencing that both Cutter's own centres and contracted centres were inspected by Cutter's internal plasma procurement department, as well as the FDA and state authorities.
Published on:
27 August, 2024
A letter from Dr Moshe Sternberg to Dr Elaine Esber details an example of the Cutter System of Plasmapheresis documents.
Published on:
27 August, 2024
Travenol Laboratories implemented a Guidance for Donor Requirements Check List. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
Published on:
27 August, 2024
Travenol Laboratories implemented a Guidance for Permanent Donor Records. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
Published on:
27 August, 2024
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