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Optimization of vapor diffusion conditions for anti-CD20 crystallization and scale-up to meso batch

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posted on 04.07.2019, 13:32 by Huaiyu YangHuaiyu Yang, Benny Danilo Belviso, Xiaoyu Li, Wenqian Chen, Teresa Fina Mastropietro, Gianluca Di Profio, Rocco Caliandro, Jerry Y.Y. Heng
© 2019, MDPI AG. All rights reserved. The crystal form is one of the preferred formulations for biotherapeutics, especially thanks to its ability to ensure high stability of the active ingredient. In addition, crystallization allows the recovery of a very pure drug, thus facilitating the manufacturing process. However, in many cases, crystallization is not trivial, and other formulations, such as the concentrate solution, represent the only choice. This is the case of anti-cluster of differentiation 20 (anti-CD20), which is one of the most sold antibodies for therapeutic uses. Here, we propose a set of optimized crystallization conditions for producing anti-CD20 needle-shaped crystals within 24 h in a very reproducible manner with high yield. High crystallization yield was obtained with high reproducibility using both hanging drop vapor diffusion and meso batch, which is a major step forward toward further scaling up the crystallization of anti-CD20. The influence of anti-CD20 storage conditions and the effect of different ions on the crystallization processes were also assessed. The crystal quality and the high yield allowed the first crystallographic investigation on anti-CD20, which positively confirmed the presence of the antibody in the crystals.

Funding

This research was funded by the European Union’s Horizon 2020, Future and Emerging Technologies program (FET-OPEN), AMECRYS project (http://www.amecrys-project.eu/) under grant agreement no. 712965, and by the EPSRC (EP/N015916/1).

History

School

  • Aeronautical, Automotive, Chemical and Materials Engineering

Department

  • Chemical Engineering

Published in

Crystals

Volume

9

Issue

5

Citation

YANG, H. .... et al., 2019. Optimization of vapor diffusion conditions for anti-CD20 crystallization and scale-up to meso batch. Crystals, 9(5): 230.

Publisher

© the authors. Published by MDPI

Version

VoR (Version of Record)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Full details of this licence are available at: http://creativecommons.org/licenses/ by/4.0/

Acceptance date

16/04/2019

Publication date

2019-04-29

Copyright date

2019

Notes

This is an Open Access Article. It is published by MDPI under the Creative Commons Attribution 4.0 Unported Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/

eISSN

2073-4352

Language

en

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