Närhi Marko, Nordström Katrina
Department of Chemical Technology, Laboratory of Biochemistry and Microbiology, Helsinki University of Technology, Espoo, Finland.
Eur J Pharm Biopharm. 2005 Apr;59(3):397-405. doi: 10.1016/j.ejpb.2004.11.006.
Biopharmaceuticals product development is a broad and multidisciplinary field. Science and technology are combined with new manufacturing, regulatory and commercial challenges. However, although there is ample literature on the molecular biology and biochemistry of products, the implementation of processes from test tube to commercial scale has not received similar attention. Consequently, the present study aims to highlight, from practical point of view, some of the key issues involved with manufacturing technologies of biopharmaceuticals at a commercial scale. Regulatory requirements and investments are also addressed based on the practical experiences of start-up and small companies. Finland is used as a case-example of such companies as this is a EU-member state with strong technological growth and rapidly increasing number of biotech companies.
生物制药产品开发是一个广泛的多学科领域。科学技术与新的制造、监管和商业挑战相结合。然而，尽管关于产品的分子生物学和生物化学有大量文献，但从试管到商业规模的工艺实施却没有受到同样的关注。因此，本研究旨在从实际角度突出商业规模生物制药制造技术所涉及的一些关键问题。还将根据初创公司和小公司的实际经验探讨监管要求和投资问题。芬兰被用作这类公司的一个案例，因为它是一个技术增长强劲且生物技术公司数量迅速增加的欧盟成员国。
