Batch / PAT / QRM Process

Analysis of a Batch Fermentation Process Using Raman Analyzers

By Kaiser Optical Systems

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.

Read the application note

Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.