Cambridge Healthtech Institute's Fourth Annual

Characterization of Biotherapeutics

( 生物学疗法的特性评估 )

Improving Prediction, Screening and Characterization of New Biologic

2018年1月8日 - 9日


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 Fourth Annual Characterization of Biotherapeutics conference will present new tools, strategies and case studies on analytical development and characterization of mAbs, ADCs, bispecifics, and other novel protein formats, biosimilars, HOS, and developability. We invite you to present a poster and attend to join with colleagues in this discussion of the key challenges and solutions improving predication, screening and characterization of new biologics.

Final Agenda


7:30 am Registration and Morning Coffee

Characterization of New Biotherapeutics

9:00 Welcome by Conference Organizer

Nandini Kashyap, Conference Director, Cambridge Healthtech Institute

9:05 Chairperson's Opening Remarks

Alexey Rak, Ph.D., Head of Bio Structure and Biophysics, Integrated Drug Discovery, Sanofi R&D


9:10 Novel Low-Protein Consuming High Throughput Biophysical Methods for mAbs, ADCs and Multi-Specific Biologics Characterization

Alexey Rak, Ph.D., Head of Bio Structure and Biophysics, Integrated Drug Discovery, Sanofi R&D

Modern drug discovery operations require characterization of biomolecular interactions to be both time- and cost-effective as well as to be highly precise and reproducible. Here we report applications of novel biophysical methods nano-Diffrential Scanning Fluorimetry (nanoDSF), MicroScale Thermophoresis (MST) and kinetic stability experiments that we are applying in our biologics discovery and development for mAbs, ADCs and multi-specific biologics. The examples of the demonstrated effectiveness of the novel integrated biophysical methods will be presented and discussed.

9:50 Analytical Characterization of Next-Generation Antibody-Based Therapeutics

Jared_BeeJared Bee, Ph.D., Senior Scientist, Analytical Development Group Leader, MacroGenics, Inc.

DART® molecules are bispecific antibody-based proteins developed for a variety of indications including immune-oncology, and are designed to simultaneously bind to two targets. These versatile molecules have the potential for improved efficacy and safety profile through enhanced selectivity and recruitment of specialized effector cells. This presentation will discuss analytical characterization strategies using this novel class of molecules and other antibody molecules as case studies.

10:20 Networking Coffee Break

10:45 Engineering Biparatopic Anti-HER2 Antibody: Function Follows Form

Vaheh Oganesyan, MS, Scientist, MedImmune

11:15 Composition and Thermal Stability of Adsorbed Vaccines

Marina_KirkitadzeMarina Kirkitadze, Ph.D., Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur, Canada

The focus of this presentation is a characterization of adsorbed vaccine consisting of several protein antigens and new adjuvant. The applicability of several biophysical methods (FTIR, Raman, DSF) to characterize vaccine components in the final drug product without desorption.

11:45 Analytical QbD Applied to the Development of a Robust Reversed Phase Separation Method to Monitor Free Drug Related Impurities in an ADC

Kevin Strozyk, Sr. Research Associate, Analytical Sciences, Seattle Genetics

Quality by Design (QbD) allows for a systematic approach to method development with predefined objectives while leveraging prior method understanding. Here we present a case study for the development of a robust reversed phase UPLC separation to accurately and precisely quantify free drug related impurities (FDRI) in an ADC using components of analytical QbD including the use of an Analytical Target Profile (ATP), prior knowledge, and Design of Experiment (DoE).

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Session Break

1:00 Luncheon Presentation I: Glycans before Lunch: Rapid N-Glycan Sample Preparation Workflows for Screening and Characterization of Biotherapeutics

Aled_JonesAled Jones, Senior Product and Applications Manager, ProZyme

The structure of N-linked glycans can play a critical role in the pharmacology of therapeutic proteins, potentially affecting immunogenicity, pharmacokinetics and pharmacodynamics. This makes the characterization of N-glycans an essential part of the biotherapeutic development process. We present 3 rapid N-glycan sample preparation and analysis workflows: Gly-X with InstantPC or 2-AB Express labeling for glycan characterization by liquid chromatography, and Gly-Q for rapid screening using an integrated system with capillary electrophoresis.

1:30 Luncheon Presentation II (Sponsorship Opportunity Available)

High-Throughput Screening, Immunoassay and Biochemical Assay

2:00 Chairperson's Remarks

Czeslaw Radziejewski, Ph.D., Senior Principal Research Scientist, Biophysical Chemistry, AbbVie

2:05 In vitro Assays to Predict Immunogenicity Risk Assessment of Protein Therapeutics

Shanmuuga T. Sundaram, Ph.D., Research Advisor, BioAnalytical Sciences, Bioproduct Research and Development, Eli Lilly and Company

2:35 Deciphering the Root-Causes for Atypical PK of mAbs and Complex Biologics by Protein Engineering

Thomas_KraftThomas E. Kraft, Ph.D., Postdoctoral Scientist, Large Molecule Research, Roche Diagnostics GmbH

Therapeutic antibodies with nearly identical Fc domains show >10-fold differences in clearance. We systematically identified properties of the Fv domain that can cause atypical pharmacokinetic behavior. Using protein engineering, we created Fab mutants with defined biophysical properties and tested them in biochemical PK prediction assays and for in vivo clearance. Our results are highly relevant for predicting and improving in vivo PK based on biophysical properties and biochemical assay data.

3:05 Sponsored Presentation (Opportunity Available)

3:20 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.


4:30 Selection and Sensitivity of Biophysical Techniques in Characterization of Higher Order Structure of Proteins

Haripada_MaityHaripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company

A strong correlation among higher order structure (HOS), conformational stability, and functional properties is generally observed for proteins. Characterization of HOS is primarily performed by different biophysical techniques. The selection and sensitivity of these techniques is very important, and may depend on protein to protein. This presentation will discuss the sensitivity and limitations of different techniques used in the characterization of proteins of different sizes, and the number of intrinsic chromophores under a variety of stress conditions.

5:00 Performing Biosimilarity - An Industry Perspective on Recent Projects

Urs Lohrig, Ph.D., Labhead, Phys. Chem. Characterization, Biosimilars, Biologics Technical Development & Manufacturing, Sandoz GmbH

5:30 Biophysical Studies of Multivalent Antibody-Antigen Complexes

Czeslaw_RadziejewskiCzeslaw Radziejewski, Ph.D., Senior Principal Research Scientist, Biophysical Chemistry, AbbVie

This presentation will describe electron microscopy studies of various complexes that are formed when TNF alpha interacts with anti-TNF monoclonal antibodies.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 Close of Day


8:00 am Registration and Morning Coffee

developability assessment and analytical characterization

8:30 Chairperson's Remarks

Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company

8:35 Developability Assessment to Support Pre-Candidate Selection of Biotherapeutics

Jonathan_KingsburyJonathan S. Kingsbury, Ph.D., Principal Scientist, Global Pharmaceutical Development Biologics, Sanofi

Developability/deviceability is a critical pipeline support activity, the results of which are used to focus the field of potential candidate molecules. Such assessments can be conducted in diverse ways, with different testing compositions and timing. The benefits of a multi-checkpoint strategy for candidate credentialing completed at different stages throughout the early discovery/development timeline will be discussed. In addition, the defining qualities of a comprehensive, process-relevant assessment strategy will be discussed and explained using examples. The use of the resulting data to enable decision making for pre-candidate selection using empirical benchmarks will be highlighted.

9:05 Light-Induced Buffer Component Adduction on Protein

Ming_LeiMing Lei, Ph.D., Senior Research Associate, Protein Analytical Chemistry, Genentech

Light-induced buffer component adduction via Histidine was found in multiple commonly used buffer systems such as Histidine-acetate and Tris-HCl. These adductions on protein can potentially result in altered properties of the biotherapeutics. Detailed characterization and mechanistic works will be presented in this presentation. The effects of other common excipients are also discussed.

9:35 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Developability Assessment of Therapeutic Proteins - A Toolbox for Characterization of Different Formats

Thorsten_LorenzThorsten Lorenz, Ph.D., Group Head, Developability Assessment, Integrated Biologics Profiling, Novartis Pharma AG

The diversity and increasing complexity of new protein formats requires a change from former platform approaches often applied for antibodies, to project specific strategies. The developability assessment concept applied at Novartis combines information about early process development, aggregation propensity, stability, solubility, physicochemical properties and immunogenicity of potential candidates. This integrated approach prior to lead selection provides a thorough yet resource efficient approach. The presentation will provide an overview about the concept and provide selected case studies.

11:30 PANEL DISCUSSION: Application of New Analytical Tools and Mass Spectroscopy for Characterization of Biologics


Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company


Jonathan S. Kingsbury, Ph.D., Principal Scientist, Global Pharmaceutical Development Biologics, Sanofi

Thorsten Lorenz, Ph.D., Group Head Developability Assessment, Integrated Biologics Profiling, Novartis Pharma AG

Ming Lei, Ph.D., Senior Research Associate, Protein Analytical Chemistry, Genentech

12:00 pm Presentation to be Announced

12:30 Session Break

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Close of Characterization of Biotherapeutics Conference

* 活动内容有可能不事先告知作更动及调整。