The U.S. FDA’s Process Analytical Technology initiative provides a structure for Quality by Design deployment. As part this initiative, knowledge of industrial processes is gained using analyzer technologies to develop critical quality factors, efficient control limits, and rational specifications.
The original initiative has been extended by the FDA so that bioprocess companies can benefit from the QbD framework. This application note, offered by Kaiser Optical Systems, analyzes the development and use of fermentation analytics as per the settings of the QbD framework.
Latest from Batch
Latest from Batch
