Institute of Technical Chemistry, Leibniz University Hannover, Hannover, Germany.
Institute for Research on Innovation, Technology Management and Entrepreneurship, Leibniz University Hannover, Hannover, Germany.
Adv Biochem Eng Biotechnol. 2021;176:57-69. doi: 10.1007/10_2020_139.
The production of pharmaceuticals, industrial chemicals, and food ingredients from biotechnological processes is a vast and rapidly growing industry. While advances in synthetic biology and metabolic engineering have made it possible to produce thousands of new molecules from cells, few of these molecules have reached the market. The traditional methods of strain and bioprocess development that transform laboratory results to industrial processes are slow and use computers and networks only for data acquisition and storage. Digitalization, machine learning (ML), and artificial intelligence (AI) methods are transforming many fields - how can they be applied to bioprocessing to overcome current bottlenecks? What are the challenges, especially for regulatory issues, in the production of biopharmaceuticals? This chapter begins with a discussion of the current challenges for strain and bioprocess development and then considers how digitalization can be used to approach these tasks in completely new ways. Finally, regulatory considerations are addressed, with the goal of incorporating these issues from the outset as new digitalization methods are created.
生物技术过程生产药品、工业化学品和食品成分是一个庞大且快速发展的行业。虽然合成生物学和代谢工程的进步使得从细胞中生产数千种新分子成为可能，但这些分子中很少有进入市场。将实验室成果转化为工业过程的传统菌株和生物工艺开发方法速度较慢，仅将计算机和网络用于数据采集和存储。数字化、机器学习 (ML) 和人工智能 (AI) 方法正在改变许多领域——它们如何应用于生物加工以克服当前的瓶颈？在生物制药生产中，监管问题有哪些特别的挑战？本章首先讨论了菌株和生物工艺开发的当前挑战，然后考虑了如何使用数字化以全新的方式处理这些任务。最后，讨论了监管方面的考虑因素，目标是在创建新的数字化方法时从一开始就纳入这些问题。
