Cambridge Healthtech Institute’s 5th Annual
Process Characterization and Control
( 製程的特性評估與控制 )
A Best Practices Forum for the Translation of Process Understanding into Control Strategies for Maintaining Quality Throughout the Product Lifecycle
With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become a routine part of biologics manufacturing operations. But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. Process Characterization and Control offers a forum for the sharing of strategies and best practices from a wide range of industry companies working to implement these complex new standards.
Proposed presentations should offer case studies of strategies, best practices and technology solutions – and sharing of the rationale behind decisions associated with risk management and resource allocations related to process characterization, qualification and control.
BEST PRACTICES FOR PROCESS CHARACTERIZATION
Development of Media Prep Scale-Down Model to Support Media Characterization Strategy
Erik Read, PhD, Senior Scientist, Manufacturing Sciences and Technology, AstraZeneca
Process Characterization Planning & Execution for an Effective Product Lifecycle Management
Naveen Pathak, PhD, Head, QbD Systems, Shire
Process Characterization for Cell and Gene Therapies; Contrast with Protein Therapeutics
George Bou-Assaf, PhD, Scientist, Biogen
Application of High Throughput Chromatography for mAb Downstream Process Characterization
Patricia Rowicki, PhD, Senior Scientist, Merck
PRODUCT QUALITY STRATEGIES
Phase Appropriate Approach to Analytical Comparability
Sonia Taktak, PhD, Principal Scientist, Analytical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Update on BioPhorum Operations Group (BPOG) Roadmap for In-line Monitoring and Realtime Release
Udayanath Aich, PhD, Associate Director, Bristol-Myers Squibb
Mass Spec Analysis of Critical Reagents to Support ADC Development
Chunxiang (Kady) Yao, PhD, Scientist II, Mass Spectrometry, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.
A Practical Roadmap for Drug Substance Process Validation at a Contract Manufacturing Organization
Yunling Bai, PhD, Principal Scientist, Upstream Process Development, Gilead
OVERCOMING BIG DATA CHALLENGES IN PROCESS CHARACTERIZATION AND CONTROL
Innovative AI Tools Applicable for Process Control and Automated Device Integration
Wolfgang Paul, PhD, Principal Scientist and Digitalization Lead, Large Molecule Research, Roche Innovation Center Munich, Germany
Cross-Functional Data Harmonization for Predictive Pharmaceutical Development
Axel Wilbertz, PhD, Data Scientist, AbbVie, Germany
EMERGING TECHNOLOGIES FOR PROCESS MONITORING AND CONTROL
Inline Probes for Process Monitoring and Product Characterization
Marina Kirkitadze, PhD, Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D, Sanofi Pasteur, Canada
Oxygen Uptake Rate (OUR) Measurement of Mammalian Cells with a Real-time Off-Gas Analyzer
Wei Xue, PhD, Senior Process Scientist, Regeneron Pharmaceuticals, Inc.
Development of High-Resolution Isoelectric Chromatofocusing for In-Process Monitoring of Monoclonal Antibody Charge Variants
Helen Zhao, PhD, Bristol-Myers Squibb
Application of High Throughput and Rapid Technologies for Product Quality Assessment
Anna Brousseau, Senior Development Associate, High Throughput Sciences, Analytical & Pharmaceutical Sciences, Immunogen