To accomplish this objective, the U.S. FDA has teamed with Europe’s EMEA to provide bioprocess professionals with expanded guidelines in the form of the Process Analytical Technologies Initiative (PAT) and proven concepts such as Quality by Design (QbD). Both of which emphasize the need on the part of the bioprocess professional to understand that quality should be built into a product through a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.
Information Technology helps integrate QbD and process analytical technology into standard laboratory procedures and increase efficiency in process and product development. The presented case study carried out at the University of Delaware
demonstrates how novel information technologies of an advanced DASGIP Parallel Bioreactor System improved process development. Seamless integration of analytical data allowed for implementation of a predictive model control and comprehensive process automation.