2015 Archived Content

Cambridge Healthtech Institute’s 2nd Annual 

Characterization of Biotherapeutics 
Biophysical Characterization * Aggregate Prevention * Enhancing Developability

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 Characterization of Biotherapeutics conference highlights the latest methods and techniques for characterizing novel formats, reducing aggregates and impurities; and overcoming stability and solubility challenges in biologics and biosimilars. 

Wednesday, April 1

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2:00 pm Chairperson’s Opening Remarks

Robb KahnRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group

2:05 ADCs: Is It Time to Rethink Some Preconceptions?

Shu-Hui LiuShu-Hui Liu, Ph.D., Assoc Research Fellow, Department of Biology, Rinat-Pfizer

In this presentation, we will discuss how site-specific conjugation technologies have allowed a deeper understanding of ADC properties.

2:35 Whose Problem is Post-Translational Modifications? Discovery, Cell Culture, Chromatography or Formulation?

 ChandrashekarGanesaShekar Ganesa, Ph.D., Senior Director, Analytical Development, Global Biotherapeutics, Sanofi

Recombinant protein post-translational modifications (PTMs) are important to monitor and control during the manufacture of biologics. However, the diversity, identification and understanding the relevance of PTMs during the product development cycle can be challenging. This presentation will examine current analytical technologies and discuss how to effectively use them in characterizing the different types of PTMs. It will also discuss various strategies to manage PTMs during various stages of therapeutic protein development.

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

3:45 Chairperson’s Remarks

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


CaseStudyandUnpub3:50 Characterization Study of an Antibody with Two Light Chains

LinZhihongZhihong Lin, Ph.D., Principal Scientist, Biologics Discovery and Design, Abbott Diagnostics

We have characterized an antibody against Prothrombin Induced by Vitamin K Absence (PIVKA-II). Initial testing of the purified antibody by various biochemical methods contrasted with the results of the IEC. Biacore analysis demonstrated 3 populations of antibodies with varying reactivity to the antigen. Finally antibody gene sequencing showed myeloma’s endogenous light chain was present in the hybridoma and paired with the functional heavy chain.

4:20 Fast and Flexible Analysis of Fc-Gamma Receptor Binding Interactions on the Octet Platform

Dominic Andrada, Senior Product Manager, Pall ForteBio LLC.

From early phase candidate selection to release testing of the final product, characterizing antibody-Fc interactions with FcRs has become an integral part of the development process for biologics. Pall ForteBio Octet systems provide reliable, sensitive and rapid analyses for measuring in vitro binding kinetics of FcyR-IgG interactions.

4:35 Development of a Novel PD-1/PD-L1 Blockade Bioassay for Antibody Therapeutics in Cancer Immunotherapy

Cheng_PromegaZhi-Jie Jey Cheng, Ph.D., Group Leader, Promega Corporation

Cancer immunotherapy targeting PD-1/PD-L1 is showing promising results with durable clinical responses for several tumors. In this presentation I describe the development of a robust, bioluminescent, cell-based PD-1 blockade bioassay that can serve as a valuable tool in the assessment of therapeutic antibodies in drug screening, characterization, and lot release.

UnpublishedData4:50 Microchip Electrophoresis (MCE) for Traditional and Novel Formats of Antibody-Based Biotherapeutics

MarkusHaindlMarkus Haindl, Ph.D., Director, Development Analytics, Roche Diagnostics GmbH, Germany

Antibody analytics require the identification and assessment of specific antibody fragments and modifications. Microchip capillary electrophoresis (MCE) provides an automated high-throughput platform to monitor antibody quality. Here, we demonstrate the characterization of classical and novel formats of antibody-based biotherapeutics. The MCE assay shows a good linear range, high sensitivity and provides a resolution superior to CE-SDS for many aspects.

5:20 Analytical Characterization in Support of Protein Therapeutics Development: Linking Structure to Function

Jia-Ming Yang, Ph.D., Senior Scientist, Analytical Development, Livzon MabPharm Inc., PR China

Characterization of product heterogeneities needs to combine physicochemical and biological analysis to identify the critical quality attribute. This presentation will show several case studies of applying our analytical platform in structure and function characterization during different developmental stages. Consideration on significance and quality control of the attributes for process development is also discussed.

5:50 Close of Day

Thursday, April 2

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8:30 am Morning Coffee

8:50 Chairperson’s Opening Remarks

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


Featured Presentation

9:00 Kinetic and Thermodynamic Landscape of Protein Aggregation

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

Protein folding and aggregation are kinetically controlled processes, however understanding and drawing correlation between the two phenomenon for large and cofactor binding proteins is fairly complex. Thermodynamics stability parameters derived from kinetic and equilibrium studies predict the propensity of protein molecules to aggregation and sub-visible/visible particle formation. Case studies of co-factor modulated protein stability and correlations to aggregation/particle formation will be presented.

9:30 Subvisible Particles in Biotherapeutics: Evolving Regulatory Landscape and Product Development

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

Proteinaceous particles arise from growth of aggregates and are thus an early indicator for product stability, as well as product and process consistency. These particles are also considered a risk factor for immunogenicity. Regulatory requirements on the monitoring and reporting of these particles have been enhanced. This talk will examine this evolving technical and regulatory landscape, and their incorporation into product development strategy.

UnpublishedData10:00 New Approaches to Determine and Characterize CHO Host Cell Proteins

MarkusHaindlMarkus Haindl, Ph.D., Director, Development Analytics, Roche Diagnostics GmbH, Germany

As HCPs may act immunogenic, their characterization during manufacturing processes is of major interest. We apply electrochemiluminescent assays combined with 2D-chromatographic fractionation to monitor HCP removal. Their profiles and coverage by anti-HCP antibodies is analyzed using 2-D Fluorescence Difference Gel Electrophoresis (2-D DIGE) and Western blot techniques.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


UnpublishedData11:10 Estimation of Shelf Life based on Accelerated Stability Studies

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

Estimation of the product shelf life is often based on accelerated stability studies during the early stage of product development. These short-term studies allow rapid evaluation and optimization of product stability. Such data, however, may not always predict accurately the real-time shelf life for biologics. This presentation discusses the general principles, challenges, and options in shelf life estimation.

UnpublishedData11:40 Large Impact of Single Amino Acid Mutation on the Stability, Solubility and Viscosity of Engineered Monoclonal Antibodies

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

In protein engineering of monoclonal antibodies, conferring pH-dependent antigen binding property is a common technique for improving therapeutic potential. However, in some cases, such protein engineering, even with single amino acid mutation, has an adverse effect on the stability, solubility and viscosity of monoclonal antibody. This talk will present case studies covering these issues and discuss the strategies for protein engineering.

12:10 Combining Raman Spectroscopy and Dynamic Light Scattering for Developing Unique Insights into Protein Structure and Stability

Wei_MalvernWei Qi, Senior Scientist, Bioscience Initiative, Malvern Instruments Inc

High concentration formulation has grown into an imperative challenge to biopharmaceutical industry. In contrast to conventional technologies, Raman spectroscopy fits into this regime nicely with unique advantages: lower water signal background, wider spectra range, simultaneous measurement of secondary structure, aromatic side chain and disulfide bonds, etc. Dynamic light scattering further expands the horizontal of the knowledge by providing size distribution without sample and instrument variations. Such hybrid characterization technologies are synergistic based on tandem measurements.

12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing

2:00 Chairperson’s Opening Remarks

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


2:05 Glycosylation, Charge Distribution and in vivo Half Life of Follow-On Biologics

Yan HuangYan Huang, Ph.D., Associate Director, Bioanalytical Development, AlphaMab Co.


2:35 The Challenges and Strategies of Development and Commercialization of High Quality Biopharmaceutical Product

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

Successful development and manufacturing of a high quality product require having a closely controlled and robust manufacturing process, a well-designed formulation, and sensitive and reliable analytical methods. In this presentation, we will discuss our overall strategy and highlight some of the key steps during the product development and manufacturing to ensure our product quality. Several case studies, including mAbs and ADCs will be discussed.

3:05 Simplifying Biotherapeutic Analysis with Novel Immunoassays

John Proctor, Director, Marketing, ProteinSimple

Immunoassays are a critical part of research today in both academia and BioPharma.  Today, there exists thousands of immunoassays that are difficult to operate and which include manual steps that prevent the reproducibility required for biotherapeutic development.  ProteinSimple has redefined the Western blot with the release of it’s Simple Western platform.  

3:35 Refreshment Break

Joint Closing Session - characterizing adc for better developability

4:00 Chairperson’s Remarks

Gayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.


4:05 Analytical Strategies and Characterization of Antibody-Drug Conjugates 

 GayathariRatnaswamyGayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.

This presentation will focus on the challenges of analytical method development and characterization for ADCs in comparison with that of mAbs using case studies. Strategies for the analytical development for early stage versus late stage will be presented.

 4:35 ADCs: Biophysical Characteristics and Impact on Product and Process

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

The biophysical characteristics of ADCs are strongly impacted by the chemistry and associated linker-payload. A strong understanding of these characteristics is therefore important for robust product and process development. This talk will cover some examples illustrating these aspects for ADCs.

5:05 Close of Conference

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Celebrating 25 Years

Track 1

Protein & Antibody Engineering

Track 2

Protein Aggregation & Stability

Track 3


Track 4

Analytical Characterization of Biotherapeutics