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.

译文

生物制药产品的开发是一个广泛的,多学科的领域。科学技术与新的制造,法规和商业挑战相结合。然而,尽管关于产品的分子生物学和生物化学的文献很多,但是从试管到商业规模的过程的实施并没有受到类似的关注。因此,本研究旨在从实践的角度强调与商业规模生物制药生产技术有关的一些关键问题。监管要求和投资也要根据初创公司和小公司的实际经验来解决。芬兰以此类公司为例,因为这是一个欧盟成员国,拥有强劲的技术增长和迅速增长的生物技术公司数量。

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