Related Story
For part 1 of this article, read "Purification of Antibodies Using Novel Convecdiff Membranes Part 1: Providing High Binding Capacity at Short Residence Time and Low Pressure Drops" in the Jan. 1, 2023 issue of BioPharm International.
Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality
Publication
Article
BioPharm InternationalBioPharm 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.
Станислав Чуб/Stock.adobe.com
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.
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.
Articles in this issue
Robust Development Fuels Drive to Finish Line
Optimizing Vectors to Standardize Success
Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality
Technology for In Vivo CAR T-cell Therapy Advances
Benefits of Technologies Facilitate Adoption of Single-use Systems
Potency Assays for Novel Complex Modalities
Current Trends in Host Cell Protein Detection for Biologics Manufacturing
FDA Interactions with Industry Under Scrutiny
The Commercial Message mRNA Products Send
Proportion, Balance, and Restraint
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