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Agnes Shanley is senior editor of Pharmaceutical Technology.
By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.
Interest is growing in a new approach that allows the monitoring of critical quality attributes in real time for complex biologics such as monoclonal antibodies, opening up new possibilities in biopharmaceutical development and quality control. A consortium of biopharmaceutical companies, analytical instrumentation vendors, FDA and NIST is exploring capabilities and promoting this approach.
eBook: Bio/Pharma Laboratory Best Practices 2018
When referring to this article, please cite it as A. Shanley, "Multiple Attributes Monitoring: A New Phase in PAT for Biopharmaceuticals," Pharmaceutical Technology Bio/Pharma Laboratory Best Practices eBook (November 2018).