Cambridge Healthtech Institute’s 2nd Annual 

Characterization of Biotherapeutics 
生物制药分析表征
Enhancing Stability * Preventing Aggregation * Ensuring Comparability

April 1-2, 2015

 

As new product formats such as antibody-drug conjugates, bispecific antibodies and fusion proteins progress through development, along with the regulatory agencies’ increasing demand for higher accuracy and predictability, there is an urgent need for more accurate and faster characterization tools and strategies that will better inform companies of the structure, function and mechanisms of these new biotherapeutics.

CHI’s Analytical Characterization of Biotherapeutics conference highlights the latest methods and techniques for characterizing novel formats, improving stability and solubility, reducing aggregates and impurities; and determining comparability and biosimilarity.


BIOPHYSICAL & BIOCHEMICAL CHARACTERIZATION

Microchip Electrophoresis (MCE) For Traditional and Novel Formats of Antibody-Based Biotherapeutics

Harald Wegele, Ph.D., Head, Analytical Development and Quality Control, Pharma Technical Development Biologics Europe, Roche Diagnostics GmbH, Germany

Characterization Study of an Antibody with Two Light Chains

A. Scott Muerhoff, Ph.D., Director, Biologics Discovery and Design, Abbott Diagnostics


STABILITY AND SOLUBILITY OF ENGINEERED PROTEINS & ANTIBODIES

Estimation of Shelf Life based on Accelerated Stability Studies

Wei Wang, Ph.D., Associate Research Fellow, Pharmaceutical R&D, Pfizer, Inc.

Large Impact of Single Amino Acid Mutation on the Stability, Solubility and Viscosity of Engineered Monoclonal Antibodies

Masaru Muraoka, Ph.D., Research Scientist, Discovery Research Department, Chugai Pharmaceutical Co., Ltd., Japan

The Challenges and Strategies of Development and Commercialization of High Quality Biopharmaceutical Product

Jun Liu, Ph.D., Senior Group Leader and Senior Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Sponsored Presentation

Speaker To Be Announced





CHARACTERIZING AGGREGATES, PARTICULATES, IMPURITIES AND HCP

Kinetic and Thermodynamic Landscape of Protein Aggregation

Murali, Bilikallahalli, Ph.D., Associate Director, Vaccines & Biologics, Biopharmaceutical Development, MedImmune, Inc.

Subvisible Particles in Biotherapeutics: Evolving Regulatory Landscape and Product Development

Satish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

New Approaches to Determine and Characterize CHO Host Cell Proteins

Marcus Haindl, Ph.D., Director, Development Analytics and New Technologies, Roche Diagnostics GmbH

Biological Standards – USP-NF Approaches

Jun Liu, Ph.D., Director, Therapeutic Proteins, Biologics & Biotechnology Department, USP China




For questions about the meeting, please contact: 

Mimi Langley 郭咪咪
Sr. Conference Director
Cambridge Healthtech Institute
Phone: +1 816-472-0701
Email: mlangley@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 


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Premier Sponsor
Protein Simple 


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Promote your company’s latest technology and/or solution at PEGS CHINA. A limited number of agenda presentations (as part of a sponsorship package), exhibit space, branding, and promotional opportunities are available.


Track 1

Protein Engineering 

Track 2

Phage & Yeast Display 

Track 3

Antibody-Drug Conjugates 

Track 4

Characterization of Biotherapeutics