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评估自体和同种异体基于细胞的产品的商业机会。

Assessing commercial opportunities for autologous and allogeneic cell-based products.

机构信息

Pfizer Worldwide R&D, The Portway Building, Granta Park, Great Abington, Cambridge CB21 6GS, UK.

出版信息

Regen Med. 2012 Sep;7(5):721-32. doi: 10.2217/rme.12.40.

DOI:10.2217/rme.12.40
PMID:22954441
Abstract

The two primary cell sources used to produce cell-based therapies are autologous (self-derived) and allogeneic (derived from a donor). This analysis attempts to compare and contrast the two approaches in order to understand whether there is an emerging preference in the market. While the current clinical trials underway are slightly biased to autologous approaches, it is clear that both cell-based approaches are being aggressively pursued. This analysis also breaks down the commercial advantages of each cell-based approach, comparing both cost of goods and the ideal indication type for each. While allogeneic therapies have considerable advantages over autologous therapies, they do have a distinct disadvantage regarding potential immunogenicity. The introduction of the hybrid autologous business model provides the ability for autologous-based therapies to mitigate some of the advantages that allogeneic cell-based therapies enjoy, including cost of goods. Finally, two case studies are presented that demonstrate that there is sufficient space for both autologous and allogeneic cell-based therapies within a single disease area.

摘要

用于生产基于细胞的疗法的两种主要细胞来源是自体(自身来源)和同种异体(来自供体)。本分析试图比较和对比这两种方法,以了解市场是否出现新兴偏好。虽然目前正在进行的临床试验略偏向于自体方法,但显然两种基于细胞的方法都在积极追求。本分析还分解了每种基于细胞的方法的商业优势,比较了每种方法的商品成本和理想适应症类型。虽然同种异体疗法相对于自体疗法具有相当大的优势,但它们在潜在免疫原性方面确实存在明显的劣势。混合自体商业模式的引入为基于自体的疗法提供了减轻同种异体基于细胞疗法所享有的一些优势的能力,包括商品成本。最后,提出了两个案例研究,表明在单个疾病领域中,同种异体和自体基于细胞的疗法都有足够的空间。

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