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High-throughput process development approaches for biopharmaceuticals

By: S. Jones, et al

Reprinted with the permission of American Pharmaceutical Review, 2015 Jan-Feb
Development of a robust, reproducible biopharmaceutical manufacturing process is a critical path activity in the overall early development timeline. Platform processes have enabled companies to perform process development in shorter timeframes for molecules such as antibodies. However, technical challenges and regulatory requirements are more easily met by obtaining more process performance data during development and gaining a good understanding of critical process parameters. Today, multiple technologies and instruments are available to enable companies to develop early production processes on tight timelines while obtaining sufficient data to support process understanding. These high throughput approaches to process development are described in this article.