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Hyperoncotic human albumin solutions for intravenous fluid therapy: Effectiveness of pathogen safety and purification methods, and clinical safety

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Biosafety and Health 2023年第1期5卷 21-29页

作者： Toby Simon Philipp Schumann Michael Bieri Kathrin Schirner Eleonora Widmer CSL Plasma 900 Broken Sound ParkwaySuite 400Boca RatonFL 33487the United States CSL Behring AG Wankdorfstrasse 10CH-3014 BernSwitzerland CSL Behring Innovation GmbH Emil-von-Behring-Str.7635041 MarburgGermany

albumin solutions derived from human plasma have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease,sepsis,intensive care,and *** all plasma-derived medicinal products,there is a potential risk from pathogens,including relevant blood-borne viruses,emerging viruses,and prion *** minimize the risk of transmissible infections,the production of human albumin solutions includes rigorous donor selection and plasma testing,and effective pathogen removal and inactivation methods such as fractionation and *** with international pharmacopeial standards for purity and prekallikrein activator and aluminum content is crucial,as is post-marketing pharmacovigilance for the continuous monitoring of adverse *** review focuses on the effectiveness of manufacturing methods in the production of plasma-derived albumin,to ensure the safety of hyperoncotic solutions for volume *** evaluated evidence identified through online database(PubMed)searches and from unpublished sources,on the manufacturing and pathogen safety of plasma-derived albumin *** results confirmed the already established and evolving pathogen reduction capacity of the reviewed manufacturing ***-to-date post-marketing pharmacovigilance data and log 10 reduction factors for known and emerging pathogens during albumin production are *** the goal of ever-increasing clinical safety,potential areas of improvement,such as compliance rates for the completion of donor health questionnaires,are also *** together,the current manufacturing and pathogen reduction steps result in albumin products of greater purity than previous-generation products,with a high margin of pathogen safety against known and emerging pathogens,such as severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).

关键词： Hyperoncotic albumin human albumin solutions Viral reduction Pathogen safety Pasteurization Plasma-derived medicinal product

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