Cambridge Healthtech Institute’s 5th Annual

Process Characterization and Control

A Best Practices Forum for the Translation of Process Understanding into Control Strategies for Maintaining Quality Throughout the Product Lifecycle

August 15-16, 2019


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.

Preliminary Agenda

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


* The program is subject to change without notice, due to unforeseen reason.