Fractionated products

Foster, Peter R.; Bienek, Carol

doi:10.1017/cbo9780511545245.024

Cited by 3 publications

(5 citation statements)

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“…Early observations on the development of jaundice in the recipients of a vaccine containing pooled human lymph [ 17 ] were followed by a similar series of outbreaks of jaundice following the administration of vaccines in a pooled plasma or serum matrix (see Table 3 in [ 18 ]). Investigation of the largest of these incidents in 1941–1942 revealed that 23 of 970 donors contributing to the serum matrix had a history of jaundice [ 18 ]. Concurrently, Beeson [ 19 ] reported the transmission of hepatitis by blood and pooled plasma.…”

Section: Emergence Of Pathogen Transmission As a Risk For Recipients ...mentioning

confidence: 99%

“…This latter statement was based on the post-transfusion data available at the time, despite studies showing the retention of viral infectivity in the fractions (unpublished data by Bird et al cited in [ 21 ]. The absence of transmission of hepatitis, or any subsequently emergent blood-borne agent, by albumin fractionated by the Cohn method, has been ascribed to the heat treatment step introduced early on its use [ 18 ]. Albumin not subjected to this pasteurisation step transmitted hepatitis [ 22 ], showing that the fractionation alone does not eliminate the risk.…”

Section: Emergence Of Pathogen Transmission As a Risk For Recipients ...mentioning

confidence: 99%

“…This realisation accelerated efforts to develop viral inactivation methods for eliminating the risk of HIV (reviewed by Foster [ 18 , 47 ]). Following decades of demonstrated safety by pasteurised albumin, early efforts focussed on enhancing the safety of Factor VIII concentrate from hepatitis transmission using this method, with the additional feature of adding excipients to protect factor VIII from inactivation [ 48 ].…”

Section: The Development Of Effective Measures For Assuring Plasma Pr...mentioning

confidence: 99%

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The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

Farrugia

2023

Pathogens

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Chronic recipients of plasma products are at risk of infection from blood-borne pathogens as a result of their inevitable exposure to agents which will contaminate a plasma manufacturing pool made up of thousands of individual donations. The generation of such a pool is an essential part of the large-scale manufacture of these products and is required for good manufacturing practice (GMP). Early observations of the transmission of hepatitis by pooled plasma and serum led to the incorporation of heat treatment of the albumin solution produced by industrial Cohn fractionation of plasma. This led to an absence of pathogen transmission by albumin over decades, during which hepatitis continued to be transmitted by other early plasma fractions, as well as through mainstream blood transfusions. This risk was decreased greatly over the 1960s as an understanding of the epidemiology and viral aetiology of transfusion-transmitted hepatitis led to the exclusion of high-risk groups from the donor population and the development of a blood screening test for hepatitis B. Despite these measures, the first plasma concentrates to treat haemophilia transmitted hepatitis B and other, poorly understood, forms of parenterally transmitted hepatitis. These risks were considered to be acceptable given the life-saving nature of the haemophilia treatment products. The emergence of the human immunodeficiency virus (HIV) as a transfusion-transmitted infection in the early 1980s shifted the focus of attention to this virus, which proved to be vulnerable to a number of inactivation methods introduced during manufacture. Further developments in the field obviated the risk of hepatitis C virus (HCV) which had also infected chronic recipients of plasma products, including haemophilia patients and immunodeficient patients receiving immunoglobulin. The convergence of appropriate donor selection driven by knowledge of viral epidemiology, the development of blood screening now based on molecular diagnostics, and the incorporation of viral inactivation techniques in the manufacturing process are now recognised as constituting a “safety tripod” of measures contributing to safety from pathogen transmission. Of these three components, viral inactivation during manufacture is the major contributor and has proven to be the bulwark securing the safety of plasma derivatives over the past thirty years. Concurrently, the safety of banked blood and components continues to depend on donor selection and screening, in the absence of universally adopted pathogen reduction technology. This has resulted in an inversion in the relative safety of the products of blood banking compared to plasma products. Overall, the experience gained in the past decades has resulted in an absence of pathogen transmission from the current generation of plasma derivatives, but maintaining vigilance, and the surveillance of the emergence of infectious agents, is vital to ensure the continued efficacy of the measures in place and the development of further interventions aimed at obviating safety threats.

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Section: Emergence Of Pathogen Transmission As a Risk For Recipients ...mentioning

confidence: 99%

Section: Emergence Of Pathogen Transmission As a Risk For Recipients ...mentioning

confidence: 99%

Section: The Development Of Effective Measures For Assuring Plasma Pr...mentioning

confidence: 99%

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The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

Farrugia

2023

Pathogens

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“…Transmissions of hepatitis A, hepatitis B, hepatitis C and HIV by plasma products used in Germany in 1994 caused European regulators to advise that an additional virus inactivation step be incorporated into the manufacture of coagulation factor concentrates. 17 Additional virus inactivation steps were introduced into the manufacture of each of PFC’s relevant products in 1996, all of which had to undergo new clinical trials. A defined virus inactivation step was also added to all immunoglobulin products for intramuscular administration at the request of European regulators, 17 despite the fact that no virus transmissions had ever been associated with PFC products of this type.…”

Section: –2007mentioning

confidence: 99%

“…17 Additional virus inactivation steps were introduced into the manufacture of each of PFC’s relevant products in 1996, all of which had to undergo new clinical trials. A defined virus inactivation step was also added to all immunoglobulin products for intramuscular administration at the request of European regulators, 17 despite the fact that no virus transmissions had ever been associated with PFC products of this type. Again, new clinical trials were required to obtain regulatory approval.…”

Section: –2007mentioning

confidence: 99%

The manufacture of blood plasma products in Scotland: a brief history

Foster¹

2016

Scott Med J

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A number of essential clinical products are derived from human blood plasma, including immunoglobulin products for the treatment of infections and disorders of immunity; albumin for protein and fluid replacement and coagulation factors for the treatment of haemophilia and other disorders of haemostasis. For many years, these protein pharmaceuticals were manufactured by the Scottish National Blood Transfusion Service (SNBTS) at its Scottish Protein Fractionation Centre (PFC) in Edinburgh, a contribution which ended with the closure of the PFC in 2008. The origins and development of plasma fractionation in Scotland are summarised in this article, as well as issues which contributed to the closure of the PFC.

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Future Trends in the Plasma Products Market

Marcucci

2012

Production of Plasma Proteins for Therapeutic Use

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Fractionated products

Cited by 3 publications

References 433 publications

The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

The manufacture of blood plasma products in Scotland: a brief history

Future Trends in the Plasma Products Market

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