Cambridge Healthtech Institute’s 4th 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 16-17, 2018

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.

Preliminary Agenda

KEYNOTE PRESENTATION: 'Real-Time' Monitoring of the Structure of a Monoclonal Antibody during Chromatographic Elution from a Protein A Affinity Column

Tim Dafforn, PhD, Professor, Biotechnology, University of Birmingham, United Kingdom


The Challenges of Deploying a QBD Approach for Accelerated and Breakthrough Status Programs

Naveen Pathak, PhD, Director, Process Development, Shire

Data Management and Product Quality Database Systems for Process Development

Eoin Cosgrave, PhD, Senior Scientist, Seattle Genetics

Cell Culture Media Characterization Strategy and Related Challenges in Commercial Manufacturing

Min Zhang, PhD, Director, Manufacturing Sciences and Technology, AstraZeneca

Mass Spectrometric Monitoring of Critical Quality Attributes to Support ADC Process Characterization

Lintao Wang, PhD, Principal Scientist and Mass Spec Group Leader, Analytical and Pharmaceutical Science, ImmunoGen, Inc.


Data Driven Determination of Potency Critical Quality Attributes for an ADC

Taro Fujimori, PhD, MBA, Associate Director, Protein Analytics, Science and Technology Biologics, Abbvie

Best Practices for Specification Setting; Regulatory Expectations for Specifications

Anthony Mire-Sluis, PhD, Head, Global Quality, AstraZeneca

Microchip Electrophoresis-MS for Rapid Product Quality Determination

Seth Madren, PhD, Scientist, Biogen Idec


Real Time Product Quality Attribute Monitoring for Biologics Continuous Manufacturing

Gang Xue, PhD, Scientific Director, Amgen

Roadmap of In-Line Monitoring and Real Time Release (ILM-RTR): A Collaboration Effort by Biomanufacturers, Suppliers and Regional Research Hubs

Udayanath Aich, PhD, Principal Scientist, Sanofi Genzyme

Challenges in Drug Product Process Development for Protein Therapeutics

Amardeep Bhalla, PhD, Associate Director, Biologics Drug Product Development, Celgene


A Systematic Approach to Establish Drug Product Control Strategy During Process Characterization

Parag Kolhe, PhD, Group Leader and Associate Research Fellow, Pfizer

Continuous, Online Antibody Quality Monitoring Using a Nanofluidic Device for Continuous Biomanufacturing

Taehong Kwon, Graduate Research Assistant, Electrical Engineering and Computer Science, MIT

Upstream Process Control Strategy: Beyond Keeping Consistency with the Past

Juhong Liu, PhD, Independent CMC Consultant

A Systematic Approach to Establish Upstream Control Strategy During Process Characterization

Daniel Tong, PhD, Research Scientist, Gilead Sciences

For more details on the conference, please contact:

Kent Simmons
Senior Conference Director
Phone: 207-869-9199

For exhibit & sponsorship opportunities, please contact:

Companies A-K

Sherry Johnson
Business Development Manager
Phone: 781-972-1359

Companies L-Z

Carolyn Benton
Business Development Manager
Phone: 781-972-5412

For media partnership opportunities, please contact:

Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419


Premier Sponsors:

Millipore Sigma

Unchained Labs