Cambridge Healthtech Institute’s 6th 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 27-28, 2020

 

The demonstration of process understanding, identification of critical quality attributes, and the implementation of well-validated control strategies are now routine parts 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 standards for complex new drug products.

Preliminary Agenda

KEYNOTE PRESENTATION: Patient Centric Quality Standards and Application in Specification Setting

Anthony Mire-Sluis, PhD, SVP and Head, Global Quality, AstraZeneca Pharmaceuticals

PROCESS CHARACTERIZATION

Talk Title to be Announced

Jiu-Li Song, PhD, Director, Process Development, Amgen

Process Characterization to Successful PPQ and Submissions: Considerations for Implementing Process Lifecycle Changes for Commercial Products

Naveen Pathak, Director, Bioprocess Development, Takeda Pharmaceuticals

Qualification Challenges and Selection of Methods for GMP DS/DP Release

Junia Dushime, Scientist, Magenta Therapeutics

Drug Product Manufacturing Process Characterization and Control Strategy

Sumit Luthra, PhD, Senior Principal Scientist, Pfizer

ADOPTING AND IMPLEMENTING PROCESS ANALYTICAL TECHNOLOGIES (PAT)

Application of Near Infrared Spectroscopy for Real-Time Monitoring of Fermentation Process

Marina Kirkitadze, PhD, Head, Analytical Process Support & PAT Platform, Analytical Sciences, Sanofi Pasteur Canada

Subunit Mass Analysis for Monitoring Multiple Attributes of Monoclonal Antibodies

Peiran Liu, Senior Research Investigator, Bristol-Myers Squibb

Accelerating Attribute-Focused Process Development through the Automated Assay Preparation Platform

Becky Chan, PhD, Scientist, Amgen

A Case Study in Applying PAT to Continuous Biomanufacturing of Monoclonal Antibodies

Moo Sun Hong, Researcher, Chemical Engineering, Massachusetts Institute of Technology

Workflow for Integrated Raw Data and Root Cause Analysis by Projection Pursuit Machine Learning

Donald Jacobs, PhD, Professor, Physics, Department of Physics and Optical Science, University of North Carolina at Charlotte

 

OVERCOMING CHALLENGES

Quantitative LC-MS Approaches for Host Cell Proteins to Advance Bioprocess Development

Shawn Li, PhD, Associate Principal Scientist, Merck & Co., Inc.

Characterization of Protein Therapeutics Using Stable Isotope Tagging and Mass Spectrometry

Anton Manuilov, PhD, Associate Director, Analytical Development, Acceleron Pharma

High-Throughput DOE Using Parallel Chromatography to Enable Process Development

Kanvasri Jonnalagadda, Scientist, Strategic Analytics, Biogen

Talk Title to be Announced

Jai Pathak, PhD, Senior Scientist, Drug Product Process Development, Macrogenics




For more details on the conference, please contact:
Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 207-869-9199
Email: ksimmons@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



Premier Sponsors:

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