Centre for the History of Science, Technology and Medicine, The University of Manchester, Simon Building, Room 2.36, Manchester, M13 9PL, UK.
Hist Philos Life Sci. 2019 Jul 30;41(3):30. doi: 10.1007/s40656-019-0268-8.
This paper looks at the commodification of interferon, marketed by Hoffmann La Roche (short: Roche) as Roferon A in 1986, as a case study that helps us understand the role of pharmaceutical industry in cancer research, the impact of molecular biology on cancer therapy, and the relationships between biotech start-ups and established pharmaceutical firms. Drawing extensively on materials from the Roche company archives, the paper traces interferon's trajectory from observed phenomenon (viral interference) to product (Roferon A). Roche embraced molecular biology in the late 1960s to prepare for the moment when the patents on some of its bestselling drugs were going to expire. The company funded two basic science institutes to gain direct access to talents and scientific leads. These investments, I argue, were crucial for Roche's success with recombinant interferon, along with more mundane, technical and regulatory know-how held at Roche's Nutley base. The paper analyses in some detail the development process following the initial success of cloning the interferon gene in collaboration with Genentech. It looks at the factors necessary to scale up the production sufficiently for clinical trials. Using Alfred Chandler's concept of 'organizational capabilities', I argue that the process is better described as 'mobilisation' than as 'translation'.
本文以罗氏公司(Roche) 1986 年上市的干扰素药物 Roferon A 为例,研究了干扰素的商品化过程。这一案例有助于我们理解制药行业在癌症研究中的作用、分子生物学对癌症治疗的影响,以及生物技术初创公司与老牌制药公司之间的关系。本文广泛借鉴罗氏公司档案中的资料,追溯了干扰素从观察现象(病毒干扰)到产品(Roferon A)的发展轨迹。罗氏公司在 20 世纪 60 年代末接受了分子生物学,为其部分畅销药物专利即将到期做准备。公司资助了两个基础科学研究所,以便直接获得人才和科研成果。我认为,这些投资对于罗氏公司在重组干扰素方面的成功至关重要,此外罗氏公司在纽特利基地还拥有更普通的技术和监管方面的专业知识。本文详细分析了与基因泰克(Genentech)合作成功克隆干扰素基因后,进一步发展的过程。文章还探讨了为临床试验进行足够规模的生产所必需的因素。本文运用阿尔弗雷德·钱德勒(Alfred Chandler)的“组织能力”概念,认为这一过程与其说是“转化”,不如说是“动员”。