558 Developing Process Control Strategies for Drug Substance 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:
Kevin Seibert
Sr Eng Advisor
Eli Lilly and Company
Indianapolis, IN
46285
Email: seibert_kevin_d@lilly.com

Co-Chair:
Huiquan Wu
Chemical Engineer
FDA/CDER
DPA1/OPF/OPQ
LS64 Room 1080
Silver Spring, MD
20993
Phone Number: 3017960022
Fax Number: 301-796-9816
Email: huiquan.wu@fda.hhs.gov


Papers:
558a
Design and Implementation of a Control Strategy Using Risk-Based Probabilistic Design Principles: A Case Study in the Manufacturing an API with a Critical Impurity
Federico Lora Gonzalez, Bristol Myers Squibb; Jose E. Tabora, Bristol-Myers Squibb; Eric C. Huang, Bristol-Myers Squibb; Steven R. Wisniewski, Bristol-Myers Squibb; Thomas M. Razler, Bristol Myers Squibb; Brendan C. Mack, Bristol-Myers Squibb
558b
Proteomics Guided Process Engineering for Anti-HER2 Antibody Production
Jianfa Ou, The University of Alabama at Birmingham; Ningning Xu, The University of Alabama at Birmingham; Yingnan Si, The University of Alabama at Birmingham; Kahyong Goh, The University of Alabama at Birmingham; Patrick Ernst, The University of Alabama at Birmingham; Lufang Zhou, The University of Alabama at Birmingham; X. Margaret Liu, The University of Alabama at Birmingham
558c
Formation Mechanism and Phase Transformation Behaviors of Polymorphs of Esomeprazole Sodium
Qi Liu, Tianjin University; Shuyi Zong, Tianjin University; Hao Wu, Tianjin University; Jingkang Wang, National Engineering Research Center for Industrial Crystallization Technology, School of Chemical Engineering and Technology, Tianjin University; Hongxun Hao, Tianjin University
558d
Process Modeling of a Continuous Drug Substance Manufacturing Process
Nima Yazdanpanah, U.S. Food and Drug Administration; Thomas O'Connor, U.S. Food and Drug Administration; Celia N. Cruz, U.S. Food and Drug Administration
558e
Green Process Development and Characterization of an Alkylation Reaction to Improve API Impurity Control
Cuixian Yang, Merck & Co., Inc.; Michael Ward, Merck & Co., Inc.; Guy Humprey, Merck & Co., Inc.; Bharath Krishnamurthi, Merck & Co., Inc.; Erik Dienemann, Merck & Co., Inc.; Timothy Wright, Merck & Co., Inc.; Nicholas Rogus, Merck & Co. Inc.; Anne Mohan, Merck & Co., Inc.; Peter Maligres, Merck & Co., Inc.
558f
Leveraging PAT for Efficient Process Development Workflows
James C. Marek, AbbVie, Inc.; Eric G. Moschetta, AbbVie; Travis B. Dunn, AbbVie
558g
On-Line FTIR for Accurate Fundamental Kinetic Analysis, Real-Time Process Monitoring, and Process Controls Justification in Pharmaceutical Manufacturing
Eric G. Moschetta, AbbVie; James C. Marek, AbbVie, Inc.; Travis B. Dunn, AbbVie
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
<< Previous Session | Next Session >>