Therapeutic Solutions of Human Albumin – The Possible Effect of Process-Induced Molecular Alterations on Clinical Efficacy and Safety

Farrugia, Albert; Mori, Filippo

doi:10.1016/j.xphs.2022.03.005

Cited by 5 publications

(4 citation statements)

References 174 publications

(187 reference statements)

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“…Commercial albumin solutions mainly show a high proportion of oxidised albumin due to the manufacturing process. The stabilizers used there may have an impact on the redox potential, as well as on the binding capacity of the albumin 12 . The increase of HNA-1 was observed only directly after treatment while 12 d post treatment the initial levels were reached again.…”

Section: Discussionmentioning

confidence: 99%

“…On top of that, one has to take into account another issue of this context: if it seems possible or cannot be excluded according to the current state of knowledge, that the infusion of large amounts of commercial albumin, with a high proportion of irreversibly oxidized HNA 2, may lead to an increase of the oxidative stress level, such an infusion should be replaced by another modified commercial albumin, e. g. containing less stabilizers like octanoates. Various approaches are currently being investigated to improve the quality of commercial albumin before infusion with regard to redox state and binding properties 12 , 30 , 31 .…”

Section: Discussionmentioning

confidence: 99%

“…Commercial albumin is known to be different from endogenous albumin in terms of its redox state and its oxidative modification has an impact on its functional properties 10 – 12 . Thus, with infusing large amounts of commercial albumin, it could be assumed that changes occur in both the quantity and the quality of the patient’s albumin.…”

Section: Introductionmentioning

confidence: 99%

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Severe and long-lasting alteration of albumin redox state by plasmapheresis

Boss

Stettner

Szepanowski

et al. 2022

Sci Rep

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Plasmapheresis (PE) is an established form of therapeutic apheresis (TA). Purpose of this longitudinal prospective single center study was to investigate the effect of PE on albumin redox state (ARS), as infusion of commercial albumin during PE may alter albumin oxidation which has an impact on its functional properties and oxidative stress level. 43 subjects with autoimmune-mediated neurological disorders were included. 20 subjects in the experimental group received five treatments of PE. 13 subjects received five treatments of immunoadsorption and 10 subjects received no TA as controls. ARS was determined before and after TA and 12 days after the last TA by fractionating it into human mercaptalbumin (HMA), human non-mercaptalbumin 1 (HNA-1), and human non-mercaptalbumin 2 (HNA-2) by high-performance liquid chromatography. Irreversibly oxidised HNA-2 increased over the course of five PE treatments from 2.8% (IQR 1.3–3.7%) to 13.6% (IQR 10.9–15.9) (P < 0.01) and remained elevated 12 days after the last PE procedure (7.7% IQR 7.1–10.5, P < 0.05). The study showed for the first time that PE exerts a severe and long-lasting alteration on ARS indicating a new adverse effect of PE, that may influence oxidative stress level.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Severe and long-lasting alteration of albumin redox state by plasmapheresis

Boss

Stettner

Szepanowski

et al. 2022

Sci Rep

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“…The industrial production of plasma products has its inception in the fractionation scheme developed by Cohn and his co-workers as the result of the United States military’s interest in a stable plasma substitute to treat blood loss [ 5 , 6 ]. Cohn designed his method so that sequential harvesting of a number of protein fractions could be used to yield a number of potential therapeutic products ( Figure 1 ), in addition to the final albumin product which achieved the project’s aim of an easily administrable plasma substitute [ 7 , 8 ]. These included fibrinogen from Fraction I and immunoglobulin from Fraction II.…”

Section: Background—the Development Of Plasma-derived Pharmaceuticalsmentioning

confidence: 99%

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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Albumin hydrogels for repeated capture of drugs from the bloodstream and release into the tumor

Lee

2024

Journal of Controlled Release

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Therapeutic Solutions of Human Albumin – The Possible Effect of Process-Induced Molecular Alterations on Clinical Efficacy and Safety

Cited by 5 publications

References 174 publications

Severe and long-lasting alteration of albumin redox state by plasmapheresis

Severe and long-lasting alteration of albumin redox state by plasmapheresis

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

Albumin hydrogels for repeated capture of drugs from the bloodstream and release into the tumor

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