Advances in Characterization Methods and Approaches


With newer and more complex molecules taking the spotlight these days, companies need better and faster ways to characterize these non-traditional antibodies. These new entities, coming in the different flavors of bispecifics, conjugates, multi-components, combinations, fusions etc., do not work well with the existing platforms. Coupled with the massive amount of data coming out from mass spectrometry and the regulatory demands for more accurate particle analysis and immunogenicity risk assessment, the industry is eager for novel approaches, proven methods and creative strategies that can help them analyze, interpret and translate information into innovation.

The Advances in Characterization Methods and Approaches conference arms scientists with the tools to develop the right strategies to speed up innovation, such as developing high throughput techniques for multi-parameter analysis; using in-process control and real-time release testing to improve CMC process; improved methods for biochemical and biophysical analysis, as well as advanced techniques for better understanding of the molecule’s structure-function dynamics, charge heterogeneity, post-translational modifications, and sequence variants.

Priority Confirmed Topics and Speakers include:


NOVEL AND HIGH-THROUGHPUT METHODS: MULTI-ATTRIBUTE ANALYSIS AND REAL TIME/IN-PROCESS CONTROL

High-Throughput Mass Spectrometric Approach for Multi-Attribute Analysis

Yan Wang, Ph.D., Scientist, Analytical Development, Biogen

Releasing DS/DP Batches in “Real-Time” - Application of On-Line In-Process Control and Multi-Parameter Analytics

Hans-Martin Mueller, Director, BioProcess Development, Werthenstein BioPharma, MSD Merck

Advancing Analytical Characterization for In-Process and Purified Protein Pharmaceuticals

Anastasiya Manuilov, M.S., Senior Scientist, Analytical Research and Development, Pfizer


HD/X-MS and FPOP FOR BIOTHERAPEUTIC ANALYSIS

Fast Photochemical Oxidation of Proteins (FPOP) Complements HD Exchange for Protein Biophysics and Therapeutics

Michael Gross, Ph.D., Professor, Editor of J. Am. Soc. Mass Spectrom, and Principal Investigator, WashU MS Research Resource, Department of Chemistry, Washington University

How Precise Is That Hydrogen-Deuterium Exchange Mass Spectrometry Measurement?

Jeffrey W. Hudgens, Ph.D., Research Chemist, Biomolecular Measurement Division, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology


NEW APPROACHES AND ADVANCED TECHNIQUES FOR STRUCTURAL, BIOPHYSICAL AND POST-TRANSLATIONAL CHARCTERIZATION OF NOVEL AND COMPLEX BIOPHARMACEUTICALS

Advanced Techniques for Investigating Biotherapeutics Structural and Aggregation Issues

Tapan Das, Ph.D., Director, Mass Spectrometry and Biophysics Center of Excellence, Biologics Development, Bristol-Myers Squibb

New MS- and LC/MS- Based Approaches to Characterization of Highly Heterogeneous Biopharmaceuticals

Igor A. Kaltashov, Ph.D., Professor and Graduate Program Director, Department of Chemistry, University of Massachusetts-Amherst

Assessment of Antibody-Drug Conjugates by Bioassay

Jeffrey Glenn, Ph.D., Associate Director, Analytical Development, Bristol-Myers Squibb

Strategies for the Control of Glycosylation of a Chimeric Human-Llama Antibody

Michael Butler, Ph.D., Scientific Director of MabNet, Distinguished Professor, Department of Microbiology, University of Manitoba

A Case Study: Optimizing Glycosylation, Phosphorylation and Other Post-Translational Modifications in a Cell Line Development of a Fusion Glycoprotein

Zhuchun Wu, Ph.D., Manager, Analytical Sciences, GlaxoSmithKline


ESTABLISHING REFERENCE STANDARDS

Strategies for Establishing Reference Standards throughout a Product’s Lifecycle.

Susan Park, Ph.D., Senior QC Scientist, Global Biologics QC, Genentech, a member of the Roche Group




For questions about the meeting, please contact:
Mimi Langley
Sr. Conference Director
Cambridge Healthtech Institute
Phone: 816-472-0701
Email: mlangley@healthtech.com

For partnering & sponsorship information, please contact:
Jon Stroup
Sr. Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5483
Email: jstroup@healthtech.com