Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies
Citations Over TimeTop 10% of 2017 papers
Abstract
Continuous biomanufacturing of recombinant therapeutic proteins offers several potential advantages over conventional batch processing, including reduced cost of goods, more flexible and responsive manufacturing facilities, and improved and consistent product quality. Although continuous approaches to various upstream and downstream unit operations have been considered and studied for decades, in recent years interest and application have accelerated. Researchers have achieved increasingly higher levels of process intensification, and have also begun to integrate different continuous unit operations into larger, holistically continuous processes. This review first discusses approaches for continuous cell culture, with a focus on perfusion-enabling cell separation technologies including gravitational, centrifugal, and acoustic settling, as well as filtration-based techniques. We follow with a review of various continuous downstream unit operations, covering categories such as clarification, chromatography, formulation, and viral inactivation and filtration. The review ends by summarizing case studies of integrated and continuous processing as reported in the literature.
Related Papers
- → Transformation of biomanufacturing by single-use systems and technology(2018)24 cited
- → Developing a Continuous Bioprocessing Approach to Stromal Cell Manufacture(2017)15 cited
- → Downstream Processing; Applications and Recent Updates(2020)6 cited
- → Bioprocess Intensification: Technologies and Goals(2021)5 cited
- → Advanced Bioprocess Development and Biomanufacturing Technologies and High Throughput Miniature Bioreactors(2016)