Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.
McLean, Virginia, USA.
Biologicals. 2022 Sep;79:27-30. doi: 10.1016/j.biologicals.2022.08.003. Epub 2022 Aug 30.
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.
本文件对国际输血协会（ISBT）工作组最近举办的关于血浆蛋白治疗的国际研讨会的结论进行了评论和进一步阐述。该研讨会讨论了在中低收入国家（LMICs）中持续存在的安全血浆蛋白治疗方法严重缺乏的问题。我们提供了更多的经济和技术事实信息，强调了为什么通过逐步引入现有经过验证的技术，从国内回收的血浆中生产小规模病毒灭活的凝血因子和免疫球蛋白浓缩物是一种实用方法，可以逐步改善 LMIC 中出血性疾病和免疫缺陷患者的护理，同时支持血浆分离的进展。这一策略符合世卫组织最近的指导意见。我们强调，国际献血者和输血组织、患者组织、政府和工业界的积极参与，对于支持安全、有效和质量保证的血浆蛋白治疗方法的逐步和可持续改善至关重要。
