Laboratoires Serono S.A, An affiliate of Merck Serono, Z.I. de l'Ouriettaz, 1170, Aubonne, Switzerland.
Adv Biochem Eng Biotechnol. 2009;115:185-219. doi: 10.1007/10_2008_24.
Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.In this chapter, four case studies are presented which outline ways to reduce significantly R&D and manufacturing costs by using disposable technology in the frame of a the transfer of an antibody manufacturing process, the preparation of media and buffers in commercial manufacturing and a direct comparison of a traditional and a fully disposable pilot plant.
现代生物技术在过去 35 年中发展成为一个成熟的产业，生产和提供高价值的生物制药，带来重要的医疗和经济效益。对生物制药的需求不断增加，以及与耗时的研发工作相关的巨大成本，使得这个行业具有风险和高度竞争力。所有主要制药公司都在各个阶段实际开发的大量生物制药证实了这一趋势。这种演变的结果是对开发和制造能力的需求不断增加。传统的-不锈钢-技术的建立复杂、耗时且非常昂贵。为了应对未来对临床试验和产品推出的需求，这种重大投资的决策需要在有前途的药物的开发周期早期做出。因此，为了具有竞争力，降低研发和制造成本的可能性是非常有意义的。在这一章中，介绍了四个案例研究，概述了通过在抗体制造工艺转移、商业制造中培养基和缓冲液的制备以及传统和完全一次性中试工厂的直接比较中使用一次性技术来显著降低研发和制造成本的方法。
