The phenomenon of protein aggregation is a complex conundrum that impacts biopharmaceutical development at virtually every stage. All mechanisms of aggregation are not conclusively known, but the industry must use every effort to characterize and control this condition – and to reflect these efforts in regulatory filings. A changing landscape of assays, instrumentation and processes support the need to collect, analyze and report this data. Requirements for understanding the correlation between aggregates and immunogenicity shape analytical and clinical studies. And aggregation resulting from new higher concentration protein formulations yields new challenges in drug product development, delivery systems and manufacturing processes. The PEGS Protein Aggregation and Stability in Biopharmaceuticals meeting offers important scientific updates and a forum for dialog among the stakeholders in this challenging arena.


Subvisible Particle and Cell-Based Immunogenicity Characterization of Antibody Therapeutics Pumped through Clinical Intravenous Infusion Systems: Current In-line Filters Are not Adequate

John F. Carpenter, Ph.D., Professor, Pharmaceutical Sciences; Co-Director, Center for Pharmaceutical Biotechnology, University of Colorado Anschutz Medical Center


Predicting High-Concentration Behavior with Models and Low-Concentration Data

Christopher J. Roberts, Ph.D., Associate Professor, Chemical & Biomolecular Engineering, University of Delaware

Impact of Linker-Payload on the Physical Stability of Cysteine-Based Antibody Drug Conjugates

Jianxin Guo, Ph.D., Principal Scientist, Pfizer

Measuring Aggregation in Forced Degradation Studies

Wayne F. Reed, Ph.D., Professor, Physics, Tulane University

Characterization of Higher Molecular Weight Species in New Monoclonal Antibody Formats

Oxana Pester, Ph.D., Group Leader, Development Analytics, Pharma Technical Development Analytics, Roche Diagnostics GmbH, Germany


Understanding the Role of Aggregation in the Immunogenicity of Biotherapeutic Proteins

Jeremy Derrick, Ph.D., Professor, Molecular Microbiology, University of Manchester, United Kingdom

Presentation Topic to be Announced

Hanns-Christian Mahler, Ph.D., Lecturer, Pharmaceutical Biotechnology, University of Frankfurt, Germany

Functional and Structural Characterization of Process Related Aggregate Species of an IgG4

Flaviu Gruia, Ph.D., Scientist, Analytical Biotechnology, MedImmune

New Insight into the Stability of Concentrated Protein Solutions from a Combination of Light, Neutron and X-ray Scattering, Viscometry and Computer Simulations

Anna Stradner, Ph.D., Associate Professor, Physical Chemistry, Lund University, Sweden

Aggregate Precursors and Aggregation Kinetics

Dana Filoti, Ph.D., Senior Scientist, Protein Analytics, AbbVie


Process Control of Product Quality and Stability

Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Manufacturing Science & Technology, Genzyme (a SANOFI company)

A Novel Screening Method to Assess Developability of Antibody-Like Molecules

Neeraj Kohli, Ph.D., Group Leader, Protein Expression and Engineering, Merrimack Pharmaceuticals

Polysorbate 20 Hydrolysis and Exploring Options for Mitigating Particulate Formation

Camellia Zamiri, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech

Membrane Chromatography to Separate mAb Aggregates

Raja Ghosh, Ph.D., Professor, Canada Research Chair in Bioseparations Engineering, McMaster University

Impact of Uncontrolled Drug Substance Attributes on Downstream Biologic Product Quality

Shantanu Sule, Ph.D., Engineer, Protein Pharmaceutical Development, Biogen

Stabilization of Antibody Solutions Using a Novel Excipient

Iris Batalha, Ph.D., Postdoctoral Research Associate, Chemical Engineering and Biotechnology, University of Cambridge, United Kingdom

For more details on the conference, please contact:

For partnering and sponsorship information, please contact:

Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199

Jason Gerardi
(Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452

Carol Dinerstein
(Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471