A study conducted on the Alpha heat-treated variant Profilate recorded that it was produced from plasma pools of between 5,000 amd 32,000 donors per batch. Read more about A study conducted on the Alpha heat-treated variant Profilate recorded that it was produced from plasma pools of between 5,000 amd 32,000 donors per batch.
In an application for a renewal of the Koate HT product licence, it was noted that the product was prepared from pooled human plasma of at least 1,000 healthy donors. Read more about In an application for a renewal of the Koate HT product licence, it was noted that the product was prepared from pooled human plasma of at least 1,000 healthy donors.
In a letter to three British doctors, Linda Frith of the UK subsidiary of Cutter stated that Koate HT was prepared from pooled human plasma of at least 1,000 healthy donors. Read more about In a letter to three British doctors, Linda Frith of the UK subsidiary of Cutter stated that Koate HT was prepared from pooled human plasma of at least 1,000 healthy donors.
In a letter regarding a donor who had been diagnosed with AIDs, Dr Akin argued that the large pool dilution of the donor's plasma made it highly unlikely that transmission would occur to a recipient. It was also estimated that each pool contained plasma from as many as 7,000 to 15,000 individuals. Read more about In a letter regarding a donor who had been diagnosed with AIDs, Dr Akin argued that the large pool dilution of the donor's plasma made it highly unlikely that transmission would occur to a recipient. It was also estimated that each pool contained plasma from as many as 7,000 to 15,000 individuals.
During a product licensing application for Koate, Cutter noted that a pool consisted of 2,500 litres of plasma and approximately 4,000 human units or more, and from equal donations of at least 1000 individual donors. A given lot of Koate was usually made up from material fractionated from 3 to 5 pools. Read more about During a product licensing application for Koate, Cutter noted that a pool consisted of 2,500 litres of plasma and approximately 4,000 human units or more, and from equal donations of at least 1000 individual donors. A given lot of Koate was usually made up from material fractionated from 3 to 5 pools.
Figures provided by Travenol in support of a product licence application for Proplex referred to a plasma pool size of approximately 6,000 litres; the number of donations was not specified, but would have been higher. Read more about Figures provided by Travenol in support of a product licence application for Proplex referred to a plasma pool size of approximately 6,000 litres; the number of donations was not specified, but would have been higher.
In the absence of firm evidence of a product being implicated in the transmission of AIDS, Mr Bishop stated they he was not concerned about the absence of a product warning. Read more about In the absence of firm evidence of a product being implicated in the transmission of AIDS, Mr Bishop stated they he was not concerned about the absence of a product warning.
Christopher Bishop told the Inquiry that product literature was produced by Armour on the expectation that it would be read and considered by doctors rather than patients. Read more about Christopher Bishop told the Inquiry that product literature was produced by Armour on the expectation that it would be read and considered by doctors rather than patients.
The Armour Factorate roundel highlighting their use of 1540 donors per pool was featured on the first page of a letter from from Christopher Bishop to Dr Rosemary Biggs. Read more about The Armour Factorate roundel highlighting their use of 1540 donors per pool was featured on the first page of a letter from from Christopher Bishop to Dr Rosemary Biggs.
The introduction of FDA regulation #640.102(d) mandated large pools of at least 1,000 different donors for the manufacture of immunoglobulins, and the same large pools were then used to make factor concentrates. Read more about The introduction of FDA regulation #640.102(d) mandated large pools of at least 1,000 different donors for the manufacture of immunoglobulins, and the same large pools were then used to make factor concentrates.