Adapting the Cohn 6th cold ethanol fractionation method for small plasma pools: An innovative platform for developing hyperimmunoglobulin products against antibiotic-resistant infections in resource-limited settings

IF 1.4 4区医学 Q4 HEMATOLOGY

Transfusion and Apheresis Science Pub Date : 2025-02-05 DOI:10.1016/j.transci.2025.104093

Mikayel Ginovyan , Gayane Kirakosyan

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引用次数: 0

Abstract

The growing challenge of antimicrobial resistance (AMR) requires innovative strategies to combat multidrug-resistant infections. Vaccination is an effective approach, often considered a potential solution, however, its application against some of the most challenging multidrug-resistant bacteria, has been unsuccessful so far. In contrast, passive immunotherapy using high-titer specific antibodies can offer immediate solutions for infections where conventional antibiotics fail. This study describes the adaptation of the Cohn 6th cold ethanol fractionation method for small plasma pools, enabling the production of high-quality intravenous immunoglobulin (IVIG) products in resource-limited settings. Using small-scale plasma batches (12 L), the modified protocol achieved a yield of 4.5 ± 0.2 g/L IgG with > 98 % purity, meeting European Pharmacopoeia requirements. Additional purification, viral safety, and filtration steps ensured sterility, low endotoxin levels, and robust viral inactivation. Safety evaluations confirmed sterility, absence of pyrogens, and stability over 24 months. This scalable methodology provides a practical platform for developing hyperimmunoglobulin products targeting AMR pathogens, particularly in resource-limited countries where large-scale fractionation infrastructure is unavailable and also not suitable. Our future efforts will focus on integrating this platform into combination therapies to enhance clinical outcomes in AMR infection management.

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来源期刊

Transfusion and Apheresis Science 医学-血液学

CiteScore

3.60

自引率

5.30%

发文量

181

审稿时长

42 days

期刊介绍： Transfusion and Apheresis Science brings comprehensive and up-to-date information to physicians and health care professionals involved in the rapidly changing fields of transfusion medicine, hemostasis and apheresis. The journal presents original articles relating to scientific and clinical studies in the areas of immunohematology, transfusion practice, bleeding and thrombotic disorders and both therapeutic and donor apheresis including hematopoietic stem cells. Topics covered include the collection and processing of blood, compatibility testing and guidelines for the use of blood products, as well as screening for and transmission of blood-borne diseases. All areas of apheresis - therapeutic and collection - are also addressed. We would like to specifically encourage allied health professionals in this area to submit manuscripts that relate to improved patient and donor care, technical aspects and educational issues. Transfusion and Apheresis Science features a "Theme" section which includes, in each issue, a group of papers designed to review a specific topic of current importance in transfusion and hemostasis for the discussion of topical issues specific to apheresis and focuses on the operators'' viewpoint. Another section is "What''s Happening" which provides informal reporting of activities in the field. In addition, brief case reports and Letters to the Editor, as well as reviews of meetings and events of general interest, and a listing of recent patents make the journal a complete source of information for practitioners of transfusion, hemostasis and apheresis science. Immediate dissemination of important information is ensured by the commitment of Transfusion and Apheresis Science to rapid publication of both symposia and submitted papers.