Biopurification of monoclonal antibody (mAb) through crystallisation
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Therapeutics based on monoclonal antibody (mAb) represent the most advanced biopharmaceuticals, being able to treat a wide range of challenging diseases such as cancers and arthritis. As the scale of mAb production steadily increases with the demand for mAb-based therapeutics, the downstream biopurification continues to experience significant bottleneck due to the throughput limited nature of the current purification technology. Over the last decades, significant advances have been made in protein (and especially mAb) crystallisation as an alternative biopurification technology that offers high product stability and purity as well as scalability. This review starts with the discussion of general physicochemical properties of mAb before moving on to the in-depth discussion of the distinct phase behaviour of mAb in comparison with conventional globular proteins such as lysozyme. The final part of this review presents a summary of successful demonstrations of crystallisation scale-ups of mAb and discusses the critical factors (i.e. mixing and temperature control) to be considered.
Date Issued
2021-05-15
Date Acceptance
2021-01-16
Citation
Separation and Purification Technology, 2021, 263, pp.1-15
ISSN
1383-5866
Publisher
Elsevier BV
Start Page
1
End Page
15
Journal / Book Title
Separation and Purification Technology
Volume
263
Copyright Statement
© 2021 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor
Engineering & Physical Science Research Council (EPSRC)
Identifier
https://www.sciencedirect.com/science/article/pii/S1383586621000605?via%3Dihub
Grant Number
EP/N015916/1
Subjects
Chemical Engineering
0301 Analytical Chemistry
0904 Chemical Engineering
Publication Status
Published
Article Number
118358
Date Publish Online
2021-01-20