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 2nd Annual
Characterization of Biotherapeutics
Improving Prediction, Screening and Characterization of New Biologics
January 18-19, 2016


New biotherapeutics formats are flooding the discovery and development pipelines and with this comes an increasing need for better and faster characterization tools and strategies, improved biomolecular and biophysical assays for the new biotherapeutics. The 2nd Annual Characterization of Biotherapeutics conference presents new tools, strategies and high-level case studies on analytical development and characterization of mAbs, ADCs, bispecifics and other novel protein formats. We are looking for cutting-edge tools, research findings and unpublished data to be featured at this forum.

We invite you to present a poster and join colleagues in this discussion of the key challenges and solutions improving prediction, screening and characterization of new biologics.

Preliminary Agenda 


EMERGING TRENDS IN BIOANALYTICAL CHARACTERIZATION

Emerging Bioanalytical Technologies to Characterize Biotherapeutics with Case Studies

Jihong Yang, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc.

New USP Chapter <212> Oligosaccharide Analysis for N-Glycan Analysis

Edith Chang, Ph.D., Scientific Liaison, Biologics and Biotechnology, United States Pharmacopeia


PROPERTY-BASED DEVELOPMENT, CHARACTERIZATION AND DEVELOPABILITY ASSESSMENT

Conjugation and Aggregation Aspects of an Antibody-Drug Conjugate: The Intimate Link between Drug Substance Process and Drug Product Quality

Atul Saluja, Ph.D., Senior Research Investigator II, Drug Product Science & Technology, Bristol-Myers Squibb

Use of a Slope Measurement Method Employing Variable Pathlength UV-Vis Technology to Determine Antibody Concentration and Payload (Drug)-to-Antibody Ratio (DAR) in ADCs

Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

In silico Prediction of Tryptophan and Methionine Oxidation

Alexander Jarasch, Ph.D., Bioinformatics Scientist, Pharma Research and Early Development, Therapeutic Modalities, Roche Innovation Center Penzberg, Roche


TOOLS TO SUPPORT COMPARABILITY ASSESSMENT, CONTROL STRATEGY AND CRITICAL QUALITY ATTRIBUTES

Characterization of Product Variants Observed during Pre-Comparability Assessment of a Monoclonal Antibody

Shawn Russell, Ph.D., Senior Scientist, Process Development, Five Prime Therapeutics

Mass Spec Application in Analytical Comparability and Biosimilarity

Yan-Hui Liu, Ph.D., Principal Scientist, Sterile Product and Analytical Development, Biological Development, Merck

High-Throughput Analytical Technologies for Accelerated Bioprocess Development and Continuous Processing

Jun Hyuk Heo, Analytical Scientist, Bioprocess Technology and Expression (BTE), Merck Co., Inc.


CHARACTERIZATION OF BIODISTRIBUTION
AND IN VIVO FATE OF BIOLOGICS

Probing the Stability of a Biotherapeutic in Ocular Matrices

Kelly Loyet, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Research, Genentech, Inc.


CHARACTERIZATION OF BISPECIFIC ANTIBODIES
AND NEW BIOTHERAPEUTICS

Development and Characterization of Novel Antibody Formats

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

Purity Analysis of Bispecific Antibodies by Affinity Capillary Electrophoresis

Kathir Muthusamy, Ph.D., Staff Scientist, Regeneron Pharmaceuticals, Inc.

Developability Risks that Are Particular to Bispecific Antibodies

Mark Chiu, Ph.D., Associate Director, Multispecific Biologics Engineering, Janssen Biotechnology

Challenges and Chances for Bioanalysis of Bispecific Antibodies

Kay Stubenrauch, Ph.D., Senior Principal Scientist, Pharmaceutical Sciences, Roche/Genentech, pRED

Fujifilm DiosynthPresentation to be Announced


WyattPresentation to be Announced






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