Challenging Protein A
Financial opportunities are driving many technology developers to try replacing protein A, but users are growing less motivated to implement alternatives that offer only incremental improvements. For an alternative technology to seriously challenge protein A’s dominance in the antibody-purification market, simple replacement will not be enough. As Pete Gagnon describes, it will need to offer a true paradigm shift. And a few such candidates are now emerging.
New Approaches to Process Validation
The new process validation guidance asks companies in the United States and Europe to adopt life-cycle approaches — beyond the traditional three-to-five lots run at the center point of proposed ranges for operating parameters. In this article, a consensus paper from the January 2013 CMC Strategy Forum addresses how companies can leverage product design and process development information to facilitate adapting the Quality by Design paradigm more closely — allowing for a science- and risk-based selection of critical process parameters, key process indicators, and appropriate specification criteria.
Also published this month as part of the BioProcess International Supplement Series - Vaccines: New Tools and Technologies for an Expanding Industry
Also Available Online-only in the BPI Extra section of BioProcessintl.com:
Ask the Expert: The Future of Protein A
BPI’s managing editor Maribel Rios talked with Karol Lacki (staff scientist at GE Healthcare Biosciences) about the use and future of protein A in bioprocessing. Its selectivity, robustness, and well-known ability to bind to a wide range of IgG molecules have made protein A a widely accepted affinity resin for current purification streams. Nonetheless, the industry has raised some concerns over cost, productivity, and other issues. That has led to the development of novel alternatives for purification that reportedly offer advantages o
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