January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 7th Annual
Protein Aggregation and Emerging Analytical Tools
Mechanism, Prediction, Screening, Immunogenicity and Formulation Challenges
January 21-22, 2016

The popular Protein Aggregation and Emerging Analytical Tools conference covers latest trends, challenges and solutions in understanding, characterization and mitigation of protein aggregation. It features in-depth case studies, new and unpublished data and interactive discussions on mechanisms of aggregation, new tools for detection and quantitation of aggregates, and how the data is used in regulatory filings. It also discusses mechanistic understanding of protein aggregation and present case studies on prevention of particle formation by engineering and formulation approaches, impact of aggregation on production, aggregates as a factor for immunogenicity, and approaches for improvement of biophysical properties of protein solutions. We are looking for cutting-edge research findings and unpublished data to be featured at this forum.

We invite you to present a poster and join colleagues from around the world in this discussion of the key challenges and solutions in protein aggregation in biotherapeutics.

Preliminary Agenda 


PREDICTING AND UNDERSTANDING MECHANISMS
OF PROTEIN AGGREGATION


KEYNOTE PRESENTATION
Aggregation of Antibodies

Dimiter S. Dimitrov, Ph.D., Senior Investigator, Protein Interaction Group, FNLCR, NCI, National Institute of Health


The Mechanistic Understanding Protein Aggregation

Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

pH and Conformation Modulate Copper-Mediated Fragmentation of the IgG1 Hinge Region

Zephania Kwong Glover, MSc, Senior Research Associate, Late Stage Pharmaceutical Development, Genentech, Inc.

Modelling of the Aggregation Kinetics of a Monoclonal Antibody

Henrik Rajesh Kumar Parshad, Ph.D., Principal Scientist, Biopharm Formulation Development, Novo Nordisk A/S


CHARACTERIZATION AND CONTROL OF AGGREGATES: NEW TOOLS, FORMULATION SCREENING AND STABILITY

Characterization of High-Concentration Monoclonal Antibodies by Combined DLS and Raman Spectroscopy

Geetha Thiagarajan, Ph.D., Associate Principal Scientist, Sterile Product and Analytical Development, Merck

Novel Chromatography-Based Approaches to Investigate Protein-Protein Interactions and Its Application in Formulation Screening Workflows

Sanket Patke, Ph.D., Research Investigator, Drug Product Science and Technology, Pharmaceutical Development, Bristol-Myers Squibb

Assessing Biotherapeutics Stability Using Raman Spectroscopy

Marinella Sandros, Ph.D., Assistant Professor, Department of Nanoscience, University of North Carolina at Greensboro

Site-Directed Spin Labeling for Detection of Protein Aggregation: An Emerging Analytical Tool

Lawrence Berliner, Ph.D., Professor of Chemistry and Biochemistry, University of Denver; Emeritus, Ohio State University

Innovative Approaches to Controlling Aggregation of Therapeutic Proteins

Jan Jezek, Ph.D., CSO, Research & Development, Arecor Ltd.


PROCESS AND PACKAGING FACTORS AFFECTING AGGREGATION, SAFETY AND EFFICACY OF BIOLOGICS

Predicting the Risk of Extractables and Leachables (E&L) Interacting with Therapeutic Proteins

Kim Li, Ph.D., DABT, MPH, Senior Manager, Environment, Health, Safety and Sustainability, Amgen, Inc.

Extractables & Leachables in Liquid Formulations of Proteins: Impact on Stability, Aggregation, Potency and Immunogenicity of Drug Product

Joël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen

Talk Title to be Announced

Marisa K. Joubert, Ph.D., Senior Scientist, Process & Product Development, Amgen, Inc.

Investigation of Reversible Self-Association during Early-Stage Development of a Low-Concentration Antibody-Drug Conjugate

Elizabeth Bartlett, Scientist II, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.

Characterizing Changes in Protein Quality Attributes to Assess Leachable Risks from Single-Use Bioprocess Containers

Nina Xiao, Ph.D., Senior Research Associate, Late Stage Pharmaceutical Development, Genentech, Inc.




For questions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute
Phone: 541-482-4709
Email: mlieberman@healthtech.com  

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com