697 Control Strategy Development for Continuous Drug Substance and Drug Product Manufacture


Description:
These sessions highlight the methodologies and examples of selection and monitoring of critical quality attributes (CQA) to ensure robust manufacturing process and desired performance in drug substance or drug product processes. Examples of the challenges and successes associated with the development and implementation of advanced control strategies, such as model predictive control and multivariate control, are discussed in these sessions. Examples of academic and industrial research involving the novel use of Process Analytical Technology (PAT) Tools for on-line monitoring of CQAs, applications of lab-based PAT to either identify scalable process fingerprints or determine clinically relevant process endpoints, and advancements in technologies and methods toward real-time monitoring and release are also of interest in these sessions. Submissions to sessions I-III of this topic are considered for oral presentations.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Product Design (12G)


Chair:
James C. Marek
Principal Resarch Engineer
AbbVie, Inc.
Global Pharmaceutical Research & Development - Center for Process Analytical Technology
1 North Waukegan Rd
North Chicago, IL
60064-1802
Email: james.marek@abbvie.com

Co-Chair:
Nima Yazdanpanah
Research Scientist
Food and Drug Administration
Center for Drug Evaluation and Research
Silver Spring, MD
Email: nima@mit.edu


Papers:
697a
Process Modelling, Simulation and Optimisation for Continuous Biopharmaceutical Manufacturing
Samir Diab, University of Edinburgh; Haruku Shirahata, The University of Tokyo; Hirokazu Sugiyama, The University of Tokyo; Dimitrios I. Gerogiorgis, University of Edinburgh
697b
Process Control Strategies for Pharmaceutical Drug Product Continuous Manufacturing – Where Are We Now and Where Do We Go from Here?
Ian Leavesley, Modern Pharma Consulting
697c
Data Accuracy for Smart Manufacturing in Continuous Pharmaceutical Systems
Sudarshan Ganesh, Purdue University; Mariana Moreno, Purdue University; Qinglin Su, Purdue University; Yash Shah, Purdue University; Zoltan K. Nagy, Purdue University; G. V. Rex Reklaitis, Purdue University
697d
Impurity Control in the Continuous Reactive Crystallization of Beta-Lactam Antibiotics
Matthew A. McDonald, Georgia Institute of Technology; Andreas S. Bommarius, Georgia Institute of Technology; Ronald W. Rousseau, Georgia Institute of Technology; Martha A. Grover, Georgia Institute of Technology
697e
Continuous Processing of Complex Dosage Forms: Liposomes and Polymeric Micelles
Antonio Costa, UConn; Raj Mukherjee, UConn; Anand Gupta, UConn; Gowtham Yenduri, UConn; Xiaoming Xu, Office of Testing and Research, U.S. Food and Drug Administration; Celia N. Cruz, U.S. Food and Drug Administration; Bodhisattwa Chaudhuri, University of Connecticut; Diane Burgess, UConn
697f
Active Process Control in the Quality-By-Design (QbD) Implementation of Pharmaceutical Continuous Tablet Manufacturing
Qinglin Su, Purdue University; Yasasvi Bommireddy, Purdue University; Sudarshan Ganesh, Purdue University; Marcial Gonzalez, Purdue University; Gintaras V. Reklaitis, Purdue University; Zoltan K. Nagy, Purdue University
697g
Modelling and Control of Continuous Wet Granulation in Co-Rotating Twin Screw Using Process Analytical Tools (PAT)
Hamza Ismail, Bernal Institute, University of Limerick; Darren Whitaker, Pharmaceutical Manufacturing Technology Centre; Ahmad Albadarin, University of Limerick; Mehakpreet Singh, Bernal Institute, University of Limerick; Gavin Walker, Bernal Institute, University of Limerick
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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