Analytical Characterization

As monocloncal antibodies give way to more complex, novel biomolecules in the pipeline, the role of analytical characterization becomes even more challenging. These new biomolecules may come with higher heterogeneity or higher toxicity, resulting in higher aggregation, less stability and greater immunogenicity risk, thus there is an urgent need for more state-of-the-art technologies and robust characterization techniques. The Analytical Characterization of Biotherapeutics meeting will showcase cutting-edge tools, techniques and approaches to evaluate structure-function relationships, determine physio-chemical properties and analyze higher order structures of novel biologics as well as biosimilars.



8:50 Chairperson’s Opening Remarks

Mitchell Ho, Ph.D., Chief, Antibody Therapy Section, National Cancer Institute, NIH

9:00 Improved Methods for Designing and Evolving Antibodies

Tessier PeterPeter M. Tessier, Ph.D., Richard Baruch M.D. Career Development Associate Professor, Chemical & Biological Engineering, Rensselaer Polytechnic Institute

The biotech industry has seen an explosion in the development of therapeutic antibodies in the last decade. The advantages of antibodies are compelling. Nevertheless, there are many challenges associated with antibody selection and engineering that require key technical advances to simplify the rapid and reliable generation of potent antibody therapeutics. I will discuss our progress in addressing some of these challenges, including the design, evolution and selection of antibodies with high affinity, stability and solubility.

9:30 Engineering Principles to Generate Multivalent Antibody-TRAIL Fusion Proteins

Roland KontermannRoland Kontermann, Ph.D., Professor, Biomedical Engineering, Institute of Cell Biology and Immunology, University of Stuttgart

Fusion of TRAIL to antibody fragments has been shown to allow for a targeted delivery and the selective induction of tumor cell death. We have engineered optimized single-chain derivatives of TRAIL (scTRAIL), which were employed to develop novel multivalent antibody-scTRAIL fusion proteins with improved properties. These multivalent fusion proteins were generated employing either scFv-driven homodimerization or various separate homodimerization modules. Targeting and controlled dimerization of scTRAIL fusion proteins provides a strategy to enforce apoptosis induction, together with retained tumor selectivity and good in vivo tolerance.

10:00 Coffee Break

10:30 Chairperson’s Remarks

Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd


10:35 Analytical Characterization and Control Strategies for ADC

Heyi Li, Ph.D., Senior Principal Scientist and Group Leader, Biotherapeutics, Pfizer, Inc.

An antibody-drug conjugate (ADC) is typically produced by chemically linking a small molecule cytotoxin (drug) with a cancer-specific monoclonal antibody. This presentation provides an overview of control strategies and analytical and biochemical characterizations for ADCs. The talk will briefly discuss the critical quality attributes (CQAs), analytical control strategies, and provide examples of characterizations of ADCs from two common conjugation chemistries (Lysine and Cysteine). The characterizations include drug-antibody ratio (DAR), drug distribution, purity/impurity and potency.

11:05 Bio-Conjugation Approaches to Generate Bispecific Antibodies

Julie Q. Hang, Ph.D., Senior Scientist, Protein Chemistry, Genentech, Inc.

Various forms of bispecific antibodies are generated by the expression of engineered antibodies or antibody fragments. Bio-conjugation of two bispecific Fab arms provided an efficient approach to produce a stable bispecific molecule, which carries the similar conformation and biological activities as the native F(ab’)2. We also developed an orthogonal bio-conjugation approach to produce bispecific molecules through copper-less clicking reactions. Generation of multivalent bispecific molecules was also explored in bio-conjugation.

11:35 An Integrated Approach to Candidate Selection during Biologics Drug Development

Steffen Hartmann, Ph.D., Global Head, Integrated Biologics Profiling, Novartis Pharma AG

The presentation will provide an overview of our integrated biologics profiling process at Novartis Biologics. The right state-of-the-art cell line development is combined with developability assessment encompassing a variety of methods from in silico tools to identify sequence liabilities to high throughput expression and biophysical profiling to ‘in vivo fitness’ assessment as well as formulation assessment and in vitro tools for assessing immunogenicity risks. This enables the organization to select the best biologics candidate for each project for further development.

12:05 pm Sponsored Presentation (Opportunity Available)

12:35 Networking Luncheon in the Exhibit Hall with Poster Viewing

1:55 Chairperson’s Remarks

Heyi Li, Ph.D., Senior Principal Scientist and Group Leader, Biotherapeutics, Pfizer, Inc.



Alain BeckAlain Beck, Ph.D., Senior Director, Antibody and ADC Physico-Chemistry, Centre d’Immunologie Pierre Fabre, France

A plethora of new mass spectrometry (MS) methods are used for antibody structural characterization and for biosimilarity assessment. In addition, these techniques are used to design and optimize more sophisticated and potent antibody derivatives such as ADCs (OptimADCs), bi- and multispecific antibodies, and controlled mixture of antibodies. Case studies based on state-of-the art MS methods such as Native and Ion-Mobility MS, Top-Down Sequencing, Proteomics and Sheathless Capillary Electrophoresis−Tandem MS will be presented and discussed.

2:30 Protein Bioanalytical and Biophysical Characterization and Comparability

Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd

With the latest advances in analytical technologies, most biological products can now be extensively characterized in terms of their identity, heterogeneity and impurity profile. The currently available biophysical and bioanalytical methods can characterize the primary, secondary and to some extent, the higher order structure of proteins. This session will discuss how to assess comparability of and process consistence of protein products using biophysical and bioanalytical characterization technologies.

3:00 Be Dynamic: How Physico-Chemical Techniques are Moving Forward to Meet Challenges in Biotherapeutics Characterization

Luisa Iozzino, Ph.D., Associate Researcher, Protein Chemistry, Merck Serono S.p.A.

Biotherapeutics need in-depth characterization to be entirely understood. In particular, a better comprehension of higher-order structure will lead to safer and more effective biopharmaceutical products. Traditional spectroscopic techniques can be very useful for product characterization in a “dynamic mode”. Case studies in which dynamic aspects on the structure of the product have been evaluated will be presented.

3:30 Sponsored Presentation (Opportunity Available)

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing


4:40 USP Analytical Methods and Approaches for Biologics

Jun Liu, Ph.D., Principal Scientific Liaison, Global Biologics, USP China

USP’s USP-NF contains General Chapters and monographs that support the quality, safety, and potency of drug substances and products. This talk will explain the strategies used to prepare suitable monographs for biologics from multiple manufacturers and also highlight new test Chapters containing validated methods appropriate for many recombinant therapeutic products.

5:10 Analytical Sciences: Eyes and Ears of Protein Therapeutics

Ziyang Zhong, Ph.D., Vice President, Product Development, Henlius Biotech Co. Ltd.

Analytical sciences is an integral part of drug R&D. It provides structural and biological evidences to the progress of any project. Several examples will be given to illustrate the important roles that AS played in protein therapeutics discovery and development. These range from analysis of binding kinetics, glycan profile, to amino acid sequence confirmation. Common techniques used in protein analytics, including LC/MS, SPR, and flow cytometry, will be discussed.

5:40 Welcome Reception in the Exhibit Hall with Poster Viewing

6:40 Close of Day


8:30 am Registration and Morning Coffee

8:50 Chairperson’s Opening Remarks

Joe Zhou, Ph.D., CEO, Genor BioPharma


9:00 Subvisible Protein Particles Mass Calculation with Improved Accuracy Using Microflow Imaging (MFI)

Joy Zhou, Ph.D., Principal Scientist & Associate Director, Drug Product, Manufacturing Science & Technology, Shire Pharmaceuticals

Formation of subvisible particles (1–100 µm) is a major stability concern with protein therapeutics. However, particle numbers are often too low to permit for direct experimental protein content (mass) measurement. A novel, accurate, and easy-to-implement method using MFI was developed to calculate the mass of subvisible protein particles and testified with polystyrene standards and stressed mAb. This method improves estimations of protein particle mass and facilitates a better understanding of protein particle formation.

9:30 Use of Bio-Layer Interferometry (BLI)-Based Octet Platform for Biotherapeutic Drug Discovery & Development

Vishal Kamat, Ph.D., Scientist, Biomolecular HTS Center, Therapeutic Proteins, Regeneron

10:00 Sponsored Presentation (Opportunity Available)

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


11:10 Case Study of Genor BioPharma: Development and Commercialization Strategy of Therapeutic mAb in China

Joe Zhou, Ph.D., CEO, Genor BioPharma

Since 2009, Genor BioPharma has generated and tested working strategy of how to build up mAb pipeline of follow-on biologics/NME based on our sciences/technology in upstream, downstream and quality system. In this presentation, we demonstrate the positive future outlook of our current strategy using several mimic case studies such as CTA approval for GB221; comparability study approach with originators products; government funds obtained for GB221 and GB222; as well as our recent FOB commercialization through a Korea company.

11:40 Current Development in Analytical Tools and Approaches for Characterizing Biopharmaceuticals for Comparability and Implications for Biosimilars

Kate Zhang, Ph.D., Senior Director, Biopharmaceutical Development, Sanofi

With the continuing progress of analytical tools, the analytical assay could generate overwhelming amount of the data. A well-designed analytical strategy is essential to ensure the success of a comparability study which addresses the critical physical and chemical characteristics of bio-therapeutics.

12:10 pm Biosimilar mAb Higher Order Structure Comparability Analysis with Luminex Beads-Based Protein Conformational Array

Xing Wang, Ph.D., President, Array Bridge, Inc.

Biologics Higher Order Structure (HOS) is important to its safety and efficacy but difficult to define. A novel technology is developed using antibody arrays to analyze monoclonal antibody HOS, recently the technology has been adapted to the Luminex-based platform with much improved automation and throughput. Case studies will be presented to demonstrate the application of the Luminex-based antibody array in biosimilar as well as novel mAb development.

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

2:00 Close of Analytical Characterization of Biotherapeutics

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Track 1

Protein & Antibody Engineering

Track 2

Analytical Characterization of Biotherapeutics

Track 3

Next-Generation Cancer Biotherapeutics

Track 4

Protein Aggregation & Stability


Clinical and Regulatory Strategies for Domestic and Global IND And BLA Filings