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. And 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.


Presentation Topic to be Announced

Janet Cheetham, Ph.D., Executive Director, Amgen


Analytics by Design: Matching Analytical Methods to an Expected Impurity Species

Hubert Kettenberger, Ph.D., Principal Scientist, Protein Analytics, Roche Pharma Research & Early Development, Roche Innovation Center Penzberg, Germany

Presentation Title to be Announced

Ivan Correia, Ph.D., Senior Principal Research Scientist; Head, Global Protein Sciences, AbbVie Bioresearch Center

Selective, Non-Covalent Conjugation of Peptides with Proteins Using Host-Guest Chemistry

Christopher van der Walle, Ph.D., Principal Scientist, MedImmune, United Kingdom

A High-Throughput Functional Assay Screening Platform for Cancer Immunotherapies

Ying-Kai Wang, Ph.D., Senior Research Investigator, Lead Discovery and Optimization, Bristol-Myers Squibb

High-Throughput Assays for the Determination of the Potency and Comparability of Biosimilars and innovator Products

Michael G. Tovey, Ph.D., INSERM Director of Research, Laboratory of Biotechnology & Applied Pharmacology, Ecole Normale Supérieure de Cachan, France


Use of Molecular Dynamics to Predict Chemical Degradation

Trevor Swartz, Ph.D., Senior Scientist, Early Stage Pharmaceutical Development, Genentech

Producing High Quality Drug Product in an Accelerated Timeframe Using Miniaturized and Automated Approaches

Rahul Rajan, Ph.D., Director and Functional Area Head, Drug Product Formulation, Amgen Inc.

Biochemical Analysis and its Correlation with Functional Assays

Babita Parekh, Ph.D., Director, Eli Lilly and Company

Quantitative and Automated Capillary-Based Western Blot

Richard Rustandi, Ph.D., Research Fellow, Vaccine Analytical Development, Merck

The Neonatal Fc Receptor (FcRn) Binds Independently to Both Sites of the IgG Homodimer with Identical Affinity mAbs

Yasmina Abdiche, Ph.D., Research Fellow, Rinat-Pfizer

Deciphering Factors that Have Impacts on Glycosylation of mAb and its Biophysical Properties

Zhimei Du, Ph.D., Senior Principal Scientist, Merck


Resolution of Binding Equilibrium Constants for a Two-Site System Using Biophysical Methods

Michael Doyle, Ph.D., Senior Principal Scientist, Bristol-Myers Squibb

Case Study: New Developments in Binding Assays

Molly Karlinsey, Ph.D., Team Leader, GlaxoSmithKline


Hydrogen Exchange Mass Spectrometry to Address Questions of Higher Order Structure for Biotherapeutics

Roxana Iacob, Ph.D., Research Assistant Professor, Northeastern University

A Customized HDX Workflow for Locating Protein Binding Interactions and Conformational Differences

Kristopher Truncali, Ph.D., Scientist, Mass Spectrometry, Boehringer Ingelheim Pharmaceuticals

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
E-mail: ksimmons@healthtech.com

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