Department of Biotechnology, Delft University of Technology, Delft, The Netherlands.
Global CMC Development, Sanofi, Framingham, Massachusetts, USA.
Biotechnol Bioeng. 2021 Sep;118(9):3275-3286. doi: 10.1002/bit.27757. Epub 2021 Apr 2.
Continuous manufacturing is an indicator of a maturing industry, as can be seen by the example of the petrochemical industry. Patent expiry promotes a price competition between manufacturing companies, and more efficient and cheaper processes are needed to achieve lower production costs. Over the last decade, continuous biomanufacturing has had significant breakthroughs, with regulatory agencies encouraging the industry to implement this processing mode. Process development is resource and time consuming and, although it is increasingly becoming less expensive and faster through high-throughput process development (HTPD) implementation, reliable HTPD technology for integrated and continuous biomanufacturing is still lacking and is considered to be an emerging field. Therefore, this paper aims to illustrate the major gaps in HTPD and to discuss the major needs and possible solutions to achieve an end-to-end Integrated Continuous Biomanufacturing, as discussed in the context of the 2019 Integrated Continuous Biomanufacturing conference. The current HTPD state-of-the-art for several unit operations is discussed, as well as the emerging technologies which will expedite a shift to continuous biomanufacturing.
连续制造是一个成熟行业的标志，可以从石化行业的例子中看出。专利到期促进了制造企业之间的价格竞争，需要更高效、更廉价的工艺来实现更低的生产成本。在过去的十年中，连续生物制造取得了重大突破，监管机构鼓励该行业采用这种加工模式。工艺开发既耗费资源又耗时，尽管通过高通量工艺开发（HTPD）的实施，它的成本越来越低、速度越来越快，但对于集成和连续生物制造可靠的 HTPD 技术仍然缺乏，并且被认为是一个新兴领域。因此，本文旨在说明 HTPD 的主要差距，并讨论实现端到端集成连续生物制造的主要需求和可能的解决方案，这是在 2019 年集成连续生物制造会议的背景下讨论的。本文讨论了目前几种单元操作的 HTPD 最新技术，以及将加速向连续生物制造转变的新兴技术。
