Last week, the Emerson Life Sciences team participated in an exciting 2-day conference with the Food and Drug Administration (FDA). The FDA and co-sponsors, University of Rhode Island (URI) College of Pharmacy and Pharma Conference Inc., held the event at the Hyatt Regency, Bethesda, MD. The mission was to disseminate current and accurate information on Process Analytical Technology (PAT) to the pharmaceutical industry and create a venue for dialogue between PAT users, suppliers and the FDA. The conference featured the FDA’s perspective on where PAT will be applicable in the manufacturing process and the FDA’s current thinking on how PAT will be reviewed in new and abbreviated new drug applications, amendments, or supplements to an application.Several top FDA officials were on hand to present current and accurate information on PAT, as well as answers to many firsthand questions. These officials included Janet Woodcock, Director, Center for Drug Evaluation and Research; Rebeca Rodriguez, National Drug Expert Investigator from the Division of Field Investigations; and Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER. All agreed it was a must-attend conference for anyone involved in PAT and manufacturing.
Most manufacturers understand the potential advantages of Process Analytical Technology – timely measurement of critical quality attributes, faster release times, and lower costs. But widespread adoption of PAT has been slowed by practical questions about how to implement it while ensuring FDA approval. The conference provided many answers to those questions. Attendees benefited from the experience of other manufacturers who are already putting PAT to work and learned from selected industry specialists and suppliers – including Emerson – about building a business case and leveraging technology to maximize return on PAT.
As a leading supplier of PAT solutions, Emerson was thrilled to participate in this far reaching event. Presenters included Melissa Herkt, President and COO, PlantWeb® Solutions Group, who offered perspectives on technology challenges and supplier partnership alternatives. The agenda also featured Emerson’s Terry Blevins, Principal Technologist, who talked about data analytics in pharmaceutical manufacturing. Emerson’s marketing alliance partner, Optimal Industrial Automation also provided an overview of process understanding and control using a PAT framework.
The Emerson team held a networking event at the end of the first day of the conference. Attendees had the opportunity to interact directly with Emerson’s life sciences experts as well as view three demo scenarios, each demonstrating the capabilities of an integrated PAT solution based on a DeltaV control system and an Optimal synTQ data management system. The demos included:
- Blender Demo — This demonstration shows a ‘Process’ model in synTQ and a ‘Control’ model in DeltaV. A spectrometer is used to ensure that the mixture in the mixing tank is of the required percentages of the three feed materials. Corrections are made to the feed rates from the feeder tanks to ensure these remain the case. DeltaV performs all the standard control tasks associated with maintaining levels etc.
- Fluidized Bed Demo — This is an example of both the ‘Process’ and ‘Control’ model being part of a synTQ orchestration. The demo runs in two stages. The first stage demonstrates synTQ using only data acquired from the NIR and the second stage demonstrates synTQ using data from both the NIR and a Lasentech particle sizer to then control extra settings on the Fluid Bed Dryer.
- Bioreactor Demo — the demonstration shows a ‘Process’ model in synTQ and a ‘Control’ model in DeltaV. The cell culture system simulated in DeltaV and synTQ as part of this demonstration is an animal cell culture system.
All three demos expand Emerson's capability to show a best-in-class solution for PAT opportunities. For more information on the demo or additional information on Emerson’s PAT solutions, you can contact Chris Amstutz or Alan Babbitt.
