三层暗色层血小板浓缩物:利用数据建模,以更少的投入获得更多。

IF 1.6 4区 医学 Q3 HEMATOLOGY
Vox Sanguinis Pub Date : 2025-08-11 DOI:10.1111/vox.70090
Michael Cahillane, Nicola Pearce, Christine Saunders, Nicole Polidano, Stephanie O'Brien, Laura Paletto, Thomas Scorer, Chloe George
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引用次数: 0

摘要

背景和目的:威尔士血液服务中心(WBS)从四种黄皮(4BC-PC)中提取合并血小板浓缩物,实现持续的高血小板产量,超过英国规格。三种暗色涂层血小板浓缩物(3BC-PC)提供了改善供应链弹性和提高生产能力的潜力。进行数据建模以评估3BC-PC生产的局部可行性。材料和方法:从41 4BC-PC中计算血小板回收率(%),得到三个参考值(最大值、平均值和最小值)。164 bc的测量数据被用于模拟3BC-PC的生产,并进一步分析确定了制造变异性的影响。计算出的产量是根据英国、欧盟和英国的应急规范进行评估的。对WBS的潜在产量增加进行了估计,并对模型的统计显著性和效应大小进行了估计。结果:3BC-PC数据建模显示100%符合英国批准的应急措施最低要求(≥75%达到≥150 × 109/单位),而符合欧盟规范(≥90%达到≥200 × 109/单位)的范围为93.2%至100%。对英国常规规范的符合性(≥75%达到≥240 × 109/单位)在三种模拟情景中有所不同(54.5%-86.8%)。模型显示血小板浓缩物(PC)产量可能增加,其中A组和O组成分显著增加约30%-40%。结论:数据建模支持3BC-PC作为4BC-PC的可行替代方案,提供更高的生产能力。型号3BC-PC符合英国应急和欧盟规范。对英国标准规范的遵从是可变的,这表明需要进一步优化。现实世界的验证将证实这是否是一个实际的命题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Three buffy coat platelet concentrates: Use of data modelling to make more with less.

Background and objectives: The Welsh Blood Service (WBS) produces pooled platelet concentrates from four buffy coats (4BC-PC), achieving consistently high platelet yields exceeding the UK specification. Three buffy coat platelet concentrates (3BC-PC) offer the potential for improved supply chain resilience and increased production capacity. Data modelling was performed to evaluate the local feasibility of 3BC-PC production.

Materials and methods: Platelet recovery (%) was calculated from 41 4BC-PC to generate three reference values (maximum, average and minimum). Measurements from the 164 BCs were used to model 3BC-PC production, with further analysis determining the impacts of manufacturing variability. Calculated yields were assessed against UK, European (EU) and UK contingency specifications. Potential production increases for WBS were estimated alongside statistical significance and effect size of the modelling.

Results: Data modelling with 3BC-PC showed 100% compliance against UK minimum requirements approved as a contingency measure (≥75% achieving ≥150 × 109/unit), while compliance to EU specification (≥90% achieving ≥200 × 109/unit) ranged from 93.2% to 100%. Compliance to routine UK specification (≥75% achieving ≥240 × 109/unit) varied for the three modelled scenarios (54.5%-86.8%). Modelling indicated potential increases in platelet concentrate (PC) production, with notable rises for Groups A and O components of approximately 30%-40%.

Conclusion: Data modelling supports 3BC-PC as a feasible alternative to 4BC-PC, offering increased production capacity. Modelled 3BC-PC met UK contingency and EU specifications. Compliance with the UK standard specification was variable and suggests the need for further optimization. Real-world validation would confirm whether this is a practical proposition.

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来源期刊
Vox Sanguinis
Vox Sanguinis 医学-血液学
CiteScore
4.40
自引率
11.10%
发文量
156
审稿时长
6-12 weeks
期刊介绍: Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.
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