Analytical Characterization of Biotherapeutics

As China takes on novel and more complex biotherapeutics, one of the biggest challenges is the ability to quickly and accurately characterize these new molecules. Assessment of the critical quality attributes, developability, glycosylation, higher order structure, comparability and biosimilarity, are a critical component toward better product understanding.

The Analytical Characterization of Biotherapeutics track at PEGS China arms scientists with the tools that can speed up innovation, and invites scientists with creative strategies and novel techniques to share their ideas, experiences and solutions to support the development of these exciting new biotherapeutics.

Final Agenda

Wednesday, March 29, 2017

1:00 pm Registration


2:00 Chairperson’s Opening Remarks

MingQiang Zhang, Ph.D., Head, R&D, Amgen Asia

Bertil Lindmark2:05 Multimodal Cancer Therapy - Dynamic Process-Based Immuno-Oncology

Bertil Lindmark, M.D., Ph.D., CMO, ASLAN Pharmaceuticals

Novel immune-oncology approaches focusing on T-cell aggression have allowed a clear step change for several cancer forms. Therapies focused on other parts of the immune defense that take part in the immune shield of the tumor, like macrophages, dendritic cells, NK cells, and neutrophils may also be important. However, the classification and diagnosis of the immune processes at play in a given patient and methods to follow and steer immune based therapies are lacking in granularity, speed and interpretation. It is envisioned that novel treatment paradigms will be multi-modal and will need fast response gauging of tumor and systemic immune status, and will need to be designed according to dynamic evolution of immune response.

Lei Zheng2:40 Rational Combination of Immune-Oncology Agents

Lei Zheng, Ph.D., Associate Professor, Oncology and Surgery, Gastrointestinal Cancer Program, Tumor Immunology Program, Johns Hopkins University

Combination immunotherapies are being developed with goals to overcome the resistance to the single agent checkpoint inhibitors and to enhance the depth and durability of the response to the ICIs. The combination of vaccine and immune checkpoint inhibitors may overcome the resistance to the immune checkpoint inhibitors as a single agent treatment. Other treatment modalities including radiation therapy and certain chemotherapeutic agents may also prime the immune quiescent tumors if immunogenic cell deaths can be induced by these treatment modalities. Immune modulators that target different aspects of T cell activation and exhaustion or target different cellular components are more likely synergized.

3:15 Refreshment Break in the Exhibit Hall with Poster Viewing


3:50 Versatile Strategy for Controlling the Specificity and Activity of Engineered T Cells

ChanHyuk_KimChan Hyuk Kim, Ph.D., Assistant Professor, Biological Sciences, KAIST

CD19-targeting chimeric antigen receptor (CAR) T cells have generated unprecedented responses in patients with refractory B-cell malignancies. However, the inability to control the activity of this potent “live” drug has resulted in severe treatment related toxicities and the constraint in targeting more than one antigen have limited its general application. In this talk, I will discuss our recent research efforts on addressing these limitations of current CAR-T therapy.

4:20 Applying a High Content Imaging Assay Platform to Elucidate the Mechanism of Actions of Cancer Immunotherapy

Ming_LeiMing Lei, Senior Research Investigator II, Lead Discovery and Optimization, Bristol-Myers Squibb Company

Understanding the spatiotemporal regulation of immuno-cell signaling network by drug candidates is essential for developing new cancer immunotherapy, designing rational combinational therapies and to differentiate amongst existing therapies. Here we describe how to leverage high-content image analysis to provide new insights for I-O drug selection and optimization, and use novel integrated solutions for fast in-depth analysis of I-O drug mechanism of actions.


4:50 Immunotherapy – Where Do We Stand Currently?

QingCong_LinQingcong Lin, Ph.D., Vice President, Shenogen Pharma Group


Lei Zheng, Ph.D., Associate Professor, Oncology and Surgery, Gastrointestinal Cancer Program, Tumor Immunology Program, Johns Hopkins University

Hongtao Lu, Ph.D., Executive Vice President, Scientific Research, Zai Lab, Inc.

  • Immunotherapy current status, in metastatic melanoma and other solid tumors: Where do we stand currently?
  • In addition to CTLA4, PD1, PDL1, what others have great potential, such as CD28, CD40CD40L, OX40/OX40L, 4-1BB/4-1BBL, CD27/CD70, LAG3, TIM3 and additional B7 molecules
  • What are the major mechanisms for immunotherapy, macrophages, T cells, monocytes or dendritic cells?
  • Combination approaches for immunotherapy, which combinations will make best sense? mAb/mAb and mAb/IDOi
  • Toxicity will be a potential issue for combination immunotherapy, how could we select patients to minimize the adverse events, do we have good biomarkers in place?
  • The in vivo and in vitro efficacy tests have been one of key issues for immunotherapy candidate selection, what models we need to develop for solving the issue?
  • The potentials, strategies, and potential issues of oncolytical virus, CART, CD3 based bi-specific antibody, and small molecule immunomodulator technology
  • The future of immunotherapy in oncology, what’s currently on the horizon?


5:50 Close of Day Two

Thursday, March 30, 2017

8:30 Morning Coffee

8:50 Chairperson’s Opening Remarks

Shan Chung, Ph.D., Senior Scientist and Group Leader, Bioanalytical Sciences, Genentech


9:00 Integrated Technology Solutions to Support Biologics Hit to Lead and Beyond

Han Li, Ph.D., Principal Scientist, Leads Discovery & Optimization, Bristol-Myers Squibb Company

By leveraging new detection technologies, novel assay and state of art automation capabilities, we have transformed the hybridoma discovery by implementing functional assays in early screening, thus greatly improving the antibody lead selection quality and speed. We developed innovative technology platforms to enable HT MOA studies and profiling across Itargets and leads. We have also built a core team to feed bioassays and accelerate program transition from discovery to development.

9:30 The United States Pharmacopeia (USP) Standards for Characterization of Biologics

Ranjan Chakrabarti, Ph.D., Vice President, Global Head - Biologics Lab Operations, Global Biologics, United States Pharmacopeia Convention

United States Pharmacopeia (USP) is the oldest Pharmacopeia in the world involved in Standard setting process for biological medicines. Standards for biological medicines in the USP are comprised of more than 1000 documentary standards, supported by 130 Biological Reference Materials. Standard setting process for Biologics is based on the Quality Attributes of the specific drugs. USP is developing standards for different classes of Biotherapeutics. Monoclonal antibodies (mAbs) have become the single most important product class in the area of modern recombinant therapeutics. Procedural standards for the analysis of mAbs can be an important tool for the creation of consistent analytical expectations and sound technical approaches. USP has developed a General Chapter <129> that collects several of the most critical analytical procedures for mAbs and is supported by USP System Suitability Standards. The talk will focus on the present activities of USP in developing standards for Biologic Medicines. View Speaker Interview

Bioinformatics Soultions Inc10:00 Software Platform for Therapeutic Protein Characterization with LC-MS

Baozhen Shan, Ph.D., CEO, CSO, Bioinformatics Solutions, Inc.

Mass spectrometry with a multi-attribute method has a proven ability to well-characterize therapeutic proteins. This application needs a tool developed to process the data to maximize the amount of information and report it efficiently. In this study, a software platform, PEAKS AB, is presented with the following protein characterization functions: Antibody de novo sequencing with multiple-enzyme digestion; Sequence validation bottom-up and middle-down approaches; PTM quantification, glycan profiling, disulfide linkage; and Sequence variance analysis.

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

11:00 Efficient and Fit-For-Purpose Bioanalytical Support for Non-Clinical Biotherapeutic Development

Yanmei_LuYanmei Lu, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.

Bioanlytical support for biotherapeutics at discovery and preclinical stage is highly dynamic and fast paced. It involves developing and validating assays to test multiple candidate molecules in different animal species and samples matrices. Several strategies of increasing lab efficiency will be discussed, including fit-for-purpose assay validation, multiplexing and the use of generic immunoassay and automation.

11:30 How to Optimize Stability of Drug Substance and Drug Product through Integration of Rapid and Sensitive Analytical Tools with Rational Approach to Developability Assessment and Early Formulation Development

Danny_ChouDanny Chou, Ph.D., President, Compassion BioSolutions, LLC

Therapeutic proteins are challenging to develop and manufacture because their marginal stability makes them prone to denaturation and aggregation during purification, storage, distribution, and administration. While there is an absence of a definitive strategy that can prevent these instabilities against all forms of stress, we are at the dawn of a new era with the emergence of new analytical tools that can enable both prediction and real-time monitoring of protein stability. The goal of this presentation is to share how one can integrate these new tools with an advanced Design of Experiments (DOE) approach to generate maximum information even when under great time and material constraints.

12:00 Affinity & Stability: VIPs in the Analytical Characterization of Biotherapeutics

Zhuo_LiZhuo Li, Ph.D., Application Specialist, NanoTemper Technologies

To develop biotherapeutics, two very important parameters (VIPs) needs to be checked and optimized: binding affinity and protein stability. Learn how to make better informed decisions early in the biotherapeutics development workflow with MicroScale Thermophoresis and nanoDSF and thus to significantly reduce time-to-market.

12:15 Sponsored Presentation (Opportunity Available)

12:30 Networking Lunch in the Exhibit Hall with Poster Viewing

1:45 Chairperson’s Remarks

Danny Chou, Ph.D., President, Compassion BioSolutions, LLC


1:50 Effects of Glycosylation on Biological Activities of Therapeutic Antibodies

Shan Chung, Ph.D., Senior Scientist and Group Leader, Bioanalytical Sciences, Genentech

This talk will present background on glycosylation and glycoform variants in mAbs produced from CHO cells, and will discuss common methods for characterization of N-linked glycosylation in mAbs. We’ll also explore the effect of glycosylation on pharmacokinetics and biological activities of mAbs.

2:20 Higher Order Structure Analysis of Antibodies by Hydrogen/Deuterium Exchange Mass Spectrometry

Susumu_UchiyamaSusumu Uchiyama, Ph.D., Associate Professor, Graduate School of Engineering, Osaka University

Assessment of higher order structure (HOS) of proteins is important for its concrete characterization. Here our recent studies on monoclonal antibody (mAb) HOS using hydrogen/deuterium exchange mass spectrometry (HDX-MS) will be introduced. Structural comparison of mAbs in different solution conditions, structural analysis of mAbs aggregates and epitope determination will be demonstrated. Our data strongly indicate that HDX-MS is highly effective and powerful for the HOS analysis for both innovative therapeutic proteins and biosimilars.


2:50 Everything You Always Wanted to Know About Relative Potency Bioassay.... But Were Afraid To Ask

Gael_DebauveGael Debauve, Ph.D., Associate Director, Bioassay Development, UCB

Biological activity is a critical quality attribute for biopharmaceutical products and cell-based bioassays are generally used to accurately determine this activity. Because of the inherent variability in biological testing systems an absolute measure of potency is more variable than a measure of activity relative to a Standard. This has led to the adoption of new statistical tools addressing bioassay specificities. Through case studies, we will review how fitting  model and equivalence limits were defined and how the current USP1033 requirements were tackled and even exceeded by using the total error approach. Finally, we will provide some insights to the question: "Is my bioassay stability indicating?".

Waters_Black_with_tagline3:20 How Similar is My Biosimilar? A LC and MS Prospective

John C. Gebler, Ph.D., Director, Biopharma Business Development, Waters Corporation

Additional incentive has come from reducing the cost and increasing global access to life-saving therapies for patents. Biologic drugs are inherently homogeneous and innovator products are often a composite of similar species manufactured within a specific range of variability. Drug manufactures and regulators want to reduce risks to patients and ensure that biologics and safe and efficacies. The presentation will report on the use of LC/MS for in-depth, reproducible, and meaningful characterization/comparability between an innovator and biosimilar.

3:50 A Case Study - Biosimilar Development with the Change of Host Cell

Zhihua Julia Qiu, Ph.D., Vice President, R&D, Qyuns Therapeutics, Inc.

 4:20 Close of Conference

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Analytical Characterization of Biotherapeutics