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As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Regulatory agencies are themselves learning about these new formats, and to support filings, industry companies are being asked to provide ever more complex data across a wide range of analytical methods. The use of platformed analytical programs, developed as a cost and time saver by the industry, is now diminishing as novel molecules and product formats demand more individualized characterization steps. In addition, instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. The PEGS Characterization of Biotherapeutics meeting will explore these changes in the progression of analytical development, and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the development of exciting new biotherapeutics.

KEYNOTE PRESENTATION: The Analytics of Macromolecular Comparability

C. Russell Middaugh, Ph.D., Takeru and Aya Higuchi Distinguished Professor, Pharmaceutical Chemistry, University of Kansas


CHARACTERIZATION FOR BIOCONJUGATES

Native and Subunit Analysis of Antibody-Drug Conjugates

Alain Beck, Ph.D., Senior Director, Antibody and ADC Physico-Chemistry, Center of Immunology, Pierre Fabre, France

FTiH Support of an ADC: Stability, Assay Development, and Clinical Experiences

John Kellie, Ph.D., Investigator, Bioanalytical Sciences and Toxicokinetics, GlaxoSmithKline

Comparative Clinical Pharmacokinetics of Antibody-Drug Conjugates in First-in-Human Phase 1 Studies

Celene Amara, Ph.D., Senior Pharmacokineticist, Sanofi, France

Bioanalytical Strategy for Development and Validation of Ligand Binding Assays for ADCs

Seema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.

Characterization of Fusion Proteins

Wilma Lau, Ph.D., Senior Scientist, Large Molecule Research, Roche Pharma Research & Early Development, Roche Innovation Center Penzberg, Germany


CHARACTERIZATION FOR NOVEL BIOTHERAPEUTICS

Development and Characterization of Novel Antibody Formats

Melissa Geddie, Ph.D., Principal Scientist, Merrimack Pharmaceuticals

Domain-Specific Characterization for Antibody Variants

Xiaoyu Chen, Ph.D., Section Leader, Late Stage Analytics, Merck Research Laboratories


ANALYTICAL STUDIES IN SUPPORT OF PROCESS DEVELOPMENT AND PRODUCT QUALITY

Characterization and Control of Product Variants Applying QbD Principles

Jochen Felix Kepert, Ph.D., Roche Diagnostics GmbH, Germany

Protein Characterization for APC: Monitoring Product Quality Attributes for Process Development and Manufacturing

Yelena Lyubarskaya, Ph.D., Senior Principal Scientist, Biogen Idec

Novel Method for Assessing Host Cell Protein Assays

Susan Flor, Senior Research Associate, Analytical Operations, Genentech

High-Throughput Analytics in Support of Process Development and Identification of Critical Quality Attributes for Biologics

Hui Cai, Ph.D., Research Investigator, Process Development Analytics, Bristol Myers Squibb


CHARACTERIZATION OF BISPECIFIC ANTIBODIES

Analytical Development for Bispecific Antibodies

Matthew Bunce, Ph.D., Principal Research Scientist, Janssen

Pharmacology of Blood-Brain Barrier-Permeable Bispecific Antibodies

John Kelly, Ph.D., Team Lead, Proteomics, National Research Council, Canada


ANALYZING THE IN VIVO BEHAVIOR OF BIOTHERAPEUTICS

Correlating in vitro Models of Stability with in vivo Results

Tim Carlson, Ph.D., Scientific Director, Amgen

In vitro Biological Characterization of IFN-β-1a Major Glycoforms

Horst Bierau, Ph.D., Scientific Advisor, Analytical Development, Biotech Products, Merck Serono, Italy



For more details on the conference, please contact:
Kent Simmons
Program Director
Cambridge Healthtech Institute
Phone: 207-869-9199
E-mail: ksimmons@healthtech.com 

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452
E: jgerardi@healthtech.com 

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com