Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop

This document provides a commentary and further elaboration on the conclusions reached during a recent international workshop on plasma protein therapies organized by the Working Party for Global Safety of the International Society of Blood Transfusion (ISBT). The workshop addressed the profound def...

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Bibliographic Details
Published in:Biologicals 2022-09, Vol.79, p.27-30
Main Authors: Burnouf, Thierry, Epstein, Jay, Faber, Jean-Claude, Tayou Tagny, Claude, Somuah, Daniel, Smid, W. Martin
Format: Article
Language:English
Subjects:
Cryoprecipitate
Hemophilia
Immunodeficiency
Immunoglobulins
Low- and middle-income countries
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Summary:This document provides a commentary and further elaboration on the conclusions reached during a recent international workshop on plasma protein therapies organized by the Working Party for Global Safety of the International Society of Blood Transfusion (ISBT). The workshop addressed the profound deficiency in access to safe plasma protein therapies that persists in low- and middle-income countries (LMICs). We provide additional factual economic and technological information that highlights why local production of small-scale virus-inactivated concentrates of clotting factors and immune globulins from domestic recovered plasma through stepwise introduction of available validated technologies is a pragmatic approach to gradually improve the care of patients with bleeding disorders and immune deficiencies in LMIC while supporting progress toward fractionation of plasma. This strategy is in line with a recent WHO guidance. We stress that the active involvement of international blood donor and blood transfusion organizations, patient organizations, governments and industry will be essential in supporting stepwise and sustainable improvements in access to safe, effective, and quality assured plasma protein therapies. •Dramatic shortages of plasma products in low- and middle-income countries (LMIC) results in patients suffering.•Urgent actions are required in LMIC where commercial plasma products are still unavailable or unaffordable.•Pilot projects for stepwise local preparation of virus-safe clotting factors and immune globulins must be initiated.•WHO, international blood donors, transfusion and patients organizations, governments and industry can provide vital support.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2022.08.003