Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality

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BioPharm International, BioPharm International, February 2023, Volume 36, Issue 02
Pages: 22–27

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

In part I of this article (1), a novel convecdiff Protein A membrane and its characteristics were introduced. In part 2, a next generation of the convecdiff membrane was tested in a second cycling study by AGC Biologics. This second cycling study was performed over the course of 100 cycles using clarified harvest of a recombinant monoclonal antibody produced at AGC. In both studies, the analyzed critical quality attributes, yield, and LRV of different contaminants are constant over all the cycles performed. No loss in performance was observed. The performance indicators and the viral clearance abilities of the material are comparable to state-of-the-art materials. These aspects underline the robustness and applicability of the convecdiff material.

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Peer-reviewed research

Submitted: March 2, 2022
Accepted: July 21, 2022.

About the authors

Chaz Goodwine is lead downstream scientist at AGC Biologics. Katrin Töppner*, Katrin.Toeppner@Sartorius.com, is product development (PD) scientist; Patrick Adametz*, Patrick.Adametz@Sartorius.com, is process engineer; Ricarda A. Busse is product manager for membrane chromatography consumables; and Volkmar Thom is head of PD purification materials; all at Sartorius Stedim Biotech.

*To whom all correspondence should be addressed.

Article details

BioPharm International
Vol. 36, No. 2
February 2023
Pages: 22–27

Citation

When referring to this article, please cite it as Goodwine, C.; Töppner, K; Adametz, P.; Busse, R.A.; Thom, V. Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality. BioPharm International 2023, 36 (2), 22–27.