A- mab a case study in bioprocess development version 2. 1
Saturday, May 8, 2021
Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and Control Strategies
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Different CHO hosts are used routinely to develop such biologics and are combined with several expression system like the dhfr, the UCOE or the glutamine synthetase GS system. The platform described in this process guidance was developed to grow a broad range of CHO cells. The production medium supports initial cell growth and production while the highly concentrated, neutral pH feed is added to replenish depleted nutrients required for cellular function and to maintain and extend the production phase in fed-batch mode. Furthermore, the system can provide a continuous supply of multiple in-specification diluted buffers with minimal downtime and is suitable to support continuous operations such as multi-column chromatography and multi-buffer filtration operations.
Both the United States and the European Union have recently evolved guidance on how to execute process validation 1 , 2 with the prospect of a more appropriate life-cycle approach. It goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information.
Figure 1: A design space plot as determined by Jiang et al. This example shows the acceptable design space for protein loading and HIC resin hydrophobicity defined in minutes of lysozyme retention time related to high—molecular-weight content a CQA for the product and step yield an important process performance attribute. Process design space and control strategy are two fundamental elements of quality by design QbD that must be established as part of biopharmaceutical development and regulatory filings.