Cambridge Healthtech Institute’s 2nd Annual 

Characterization of Biotherapeutics 
生物制药分析表征
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 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.

Wednesday, April 1


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PLENARY KEYNOTE SESSION 

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? 

Jaume Pons, Ph.D., Senior Vice President and CSO, Rinat-PfizerJaume Pons 

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? 

Shekar 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.


BIOPHYSICAL AND BIOCHEMICAL CHARACTERIZATION 

3:50 Characterization Study of an Antibody with Two Light Chains

A. Scott Muerhoff, Ph.D., Director, 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.

4:35 Sponsored Presentation (Opportunity Available)

4:50 Microchip Electrophoresis (MCE) for Traditional and Novel Formats of Antibody-Based Biotherapeutics

Markus 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.


CHARACTERIZING AGGREGATES AND IMPURITIES 

Featured Presentation

9:00 Kinetic and Thermodynamic Landscape of Protein Aggregation

Bilikallahalli 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

Satish 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.

10:00 New Approaches to Determine and Characterize CHO Host Cell Proteins

Markus 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


STABILITY AND SOLUBILITY FOR ENGINEERED PROTEINS AND ANTIBODIES 

11:10 Estimation of Shelf Life based on Accelerated Stability Studies

Wei 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.

11:40 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

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 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.


STANDARDS & CHALLENGES IN BIOPHARM DEVELOPMENT AND COMMERCIALIZATION 

2:05 Development of Biological Standards – USP Approach

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

The U.S. Pharmacopeia Convention (USP) is a standard-setting organization recognized for its compendia and reference standards adopted in over 140 countries worldwide. USP currently offers more than 150 documentary standards in addition to 76 reference substances of biologics. USP has been playing a growing role in helping the biopharmaceutical world to accelerate the development and approval of safe and effective biological medicines.

2:35 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.

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 Presentation To Be Announced

3:35 Refreshment Break



Joint Closing Session 

Characterizing ADCs for Better Developability 

4:00 Chairperson’s Remarks 

Darshana Jani, Ph.D., Senior Manager, Clinical Assay Group, Global Innovation Pharma, Pfizer, Inc. 

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

Gayathri 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 Bioanalytical Support for the Clinical Development of Antibody-Drug Conjugate Program 

Darshana Jani, Ph.D., Senior Manager, Clinical Assay Group, Global Innovation Pharma, Pfizer, Inc. 

Antibody-Drug Conjugates (ADC) are a novel class of biotherapeutics, combining the targeted delivery capability of a monoclonal antibody with the potent cytotoxic activity of a small molecule. Due to the complex and heterogeneous nature of ADCs, a more robust bioanalytical testing strategy is required to assess the ADC pharmacokinetics (PK) and immunogenicity (anti-drug antibody (ADA) and neutralizing ADA). Challenges and solutions to ADC bioanalysis will be discussed. 

5:05 ADCs: Biophysical Characteristics and Impact on Product and Process 

Satish 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. 

5:35 Close of Conference



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Track 1

Protein & Antibody Engineering 

Track 2

Phage & Yeast Display 

Track 3

Antibody-Drug Conjugates 

Track 4

Characterization of Biotherapeutics