Burnouf Thierry, Seghatchian Jerard
Graduate Institute of Biomedical Materials and Tissue Engineering, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.
Transfus Apher Sci. 2014 Oct;51(2):113-9. doi: 10.1016/j.transci.2014.10.002.
In the late 1980s, following the human immunodeficiency virus (HIV) epidemic and transfusion-transmitted infections from plasma-derived coagulation factor concentrates to hemophiliacs, many “advanced thinkers” claimed that plasma-derived products would be completely replaced by the year 2000 by safe recombinant products in most developed countries. However, things have not turned out that way, due to both the continual progress witnessed in plasma fractionation and viral-reduction technologies and technical difficulties still being encountered in developing more cost-effective non-immunogenic, fully active recombinant therapeutic proteins. Accordingly, plasma fractionation remains a reasonably healthy industry worldwide, with an ever-increasing volume of plasma fractionated each year to meet the demands for safe and effective plasma-derived medicines at the global level. While high-income countries currently have generally good access to a panel of plasma-derived and recombinant products, desperate shortages of fractionated plasma products remain in developing economies,and patients still have to be treated inadequately. The steady development of the collection of whole blood in developing economies, to gradually cover the recognized needs for red blood cell concentrates, generates an increasing volume of recovered plasma that is currently wasted. Incentives are therefore high for those countries to consider fractionating such plasma as a means of enhancing their supply of products to treat patients, thereby also decreasing the level of dependence on imported products. Challenges of local plasma fractionation in developing economies are high, in a context where the technological and regulatory sophistication of the plasma fractionation industry is often underestimated, and the blood supply may be exposed to emerging infectious agents. In parallel, plasma product quality requirements and drivers are evolving in developed economies as is the awareness of clinicians to newer uses of products such as intravenous immunoglobulins, somewhat deviating from what currently remain the basic needs of developing countries in terms of affordable safe plasma products. Global market trends for plasma-derived products, through plasma fractionation, are still increasing, despite increasing use of recombinant products, and attention is being focused on the five Ws of the fractionation field: which products; where; when; what and how much; and who will be the main suppliers?
20世纪80年代末，随着人类免疫缺陷病毒（HIV）流行以及血浆源性凝血因子浓缩物导致血友病患者发生输血传播感染，许多“先进思想家”宣称，到2000年，在大多数发达国家，血浆源性产品将完全被安全的重组产品取代。然而，实际情况并非如此，这是因为血浆分馏和病毒灭活技术不断取得进展，同时在开发更具成本效益、无免疫原性、完全活性的重组治疗蛋白方面仍面临技术难题。因此，血浆分馏在全球范围内仍是一个相当健康的产业，每年分馏的血浆量不断增加，以满足全球对安全有效的血浆源性药物的需求。虽然高收入国家目前通常能够获得一系列血浆源性和重组产品，但发展中经济体仍然严重缺乏分馏血浆产品，患者仍得不到充分治疗。发展中经济体全血采集稳步发展，逐步满足对红细胞浓缩物的公认需求，这使得回收血浆量不断增加，而目前这些血浆都被浪费了。因此，这些国家有很大的动力考虑对这些血浆进行分馏，以增加产品供应来治疗患者，从而减少对进口产品的依赖程度。在血浆分馏行业的技术和监管复杂性常常被低估且血液供应可能接触到新出现的传染原的背景下，发展中经济体进行本地血浆分馏面临巨大挑战。与此同时，发达经济体对血浆产品质量的要求和驱动因素在不断演变，临床医生对静脉注射免疫球蛋白等产品新用途的认识也在变化，这与发展中国家目前对负担得起的安全血浆产品的基本需求有所偏离。尽管重组产品的使用不断增加，但通过血浆分馏获得的血浆源性产品的全球市场趋势仍在上升，目前人们正关注分馏领域的五个W：哪些产品；何地；何时；什么产品、数量多少；以及谁将成为主要供应商？
