7:30 am Registration and Morning Coffee
8:50 Chairperson’s Opening Remarks
Daotian Fu, Ph.D., General Manager, Livzon Mabpharm, Inc., PR China
9:00 Analytical and Quality Considerations to Support Product Characterization Comparability
Daotian Fu, Ph.D., General Manager, Livzon Mabpharm, Inc., PR China
With wide implementation of QbD in the biotech industry and recent advances in analytical technologies, strategies of analytical characterization and product comparability continues to evolve. In this presentation, we will discuss implications of QbD applications in process development, and how it may be best used to support process characterization and product comparability.
9:30 Analysis of Complex Protein Therapeutics in Support of Product Development
Xiaoyang Zheng, Ph.D., Staff Scientist II, Analytical Development, Genzyme Corporation, a sanofi Company, USA
Effective analytical support is critical to the evaluation of safety, efficacy, purity, and product consistency of a new therapeutic and its process development. This talk will focus on the strategies used to assess critical quality attributes and set specifications, as well as the use of characterization knowledge to optimize the production process.
10:00 Development of Antibody Arrays for mAb Higher Order Structure Analysis
Xing Wang, Ph.D., President, Array Bridge, USA
A novel technology is developed using antibody arrays to analyze monoclonal antibody therapeutics Higher Order Structure. This technology provides a sensitive, systematic and high-throughput approach for mAb Higher Order Structure comparability analysis, generating valuable information for cell line selection, process development and formulation development. Examples will be presented to demonstrate the application of the antibody array in biosimilar as well as novel mAb development and its complementary value to the bioassays and other analytical technologies.
10:30 Coffee Break
11:00 Assessing Antibody Fc Effector Functions via Multiple Assay Platforms
Jingyi Xiang, Ph.D., Head Bioanalytics, Eureka Therapeutics, Inc., USA
When developing and manufacturing biosimilar antibodies, it is critical to assess Fc effector function to ensure similarity to the originator compound. However, the historic lack of platforms designed to meet this specific need has made these comparisons murky at best. To address this issue, an integrated multiple assay approach is needed to explore the correlation between binding assays (such as FcR and complement binding), activity assays (including ADCC, CDC and ADCP), and glycosylation analyses.
11:30 New Approaches to Determine and Characterize CHO Host Cell Proteins
Harald Wegele, Ph.D., Director, Development Analytics, Pharma Biotech Development, Roche Diagnostics GmbH, Germany
Host cell proteins (HCPs) are process-related impurities in the development of biopharmaceuticals. As HCPs may act immunogenic, their characterization is of major interest. We apply electrochemiluminescent assays combined with prior 2D- chromatographic fractionation to monitor HCP removal. Since abundance and variety of HCPs change with the biologic molecule and/or the bioprocess, their profiles and coverage by anti-HCP antibodies is analyzed using 2-D Fluorescence Difference Gel Electrophoresis (2-D DIGE) and Western blot techniques.
12:00 pm Emerging Techniques Therapeutic Protein Characterization – Viscosity, Stability and Sub-Visible Particles
Wei Qi, Ph.D., Senior Scientist, Bioscience Development Initiative, Malvern Instruments
Three exciting novel techniques are introduced for protein therapeutics characterization. With less than 10 mL sample, we could provide simultaneous measurement of viscosity up to 160 cP and concentration up to 200 mg/mL. Raman Spectroscopy and Dynamic Light Scattering were combined to determine protein structure and hydrodynamic size directly at high concentration, and then assess the colloidal and conformation stability under applied stresses. The sub-visible particles could be counted, imaged and chemical identified automatically with the combination of microscopy and in situ Raman spectrometry.
12:30 Networking Luncheon
1:40 Chairperson’s Remarks
Boyan Zhang, Ph.D., Vice President &CSO, Beijing Mab-Works, Inc., PR China
1:45 Tools for Protein Characterization - How Can the Quality of Biosimilars Be Improved?
Anand Khedkar, M.Tech, Chief Scientific Manager, R&D, Biocon Research Limited, India
The major challenge for a biosimilar is to show the similarity to that of an innovator. This brings us to the famous question, how similar is similar enough? Can we get a reasonable idea, during the development stages regarding the critical quality attributes, which could potentially be correlated with the biological properties? This could form the basis of process development and process controls.
2:15 How to Achieve and Demonstrate Comparability of Glycosylation for a Biosimilar Compared to the Innovator Drug
Daryl L. Fernandes, Ph.D., Chief Executive, Ludger Ltd., United Kingdom
Glycosylation can greatly alter the safety and efficacy of biologic drugs. For this reason, biosimilar companies must demonstrate to regulators that the glycosylation patterns of their copy drugs are comparable to those of the innovator’s therapeutic. However, the complexity, heterogeneity and variability of glycosylation makes this one of the most challenging tasks for biosimilar developers. In this talk I will overview a practical system that biosimilar companies can follow to (a) achieve effective comparability of the glycosylation patterns of their copy drug to those of the innovator molecule and (b) demonstrate that properly to the regulatory authorities.
2:45 Developing Antibody Biosimilar Therapeutics in China: How Similar is Similar Enough?
Boyan Zhang, Ph.D., Vice President & CSO, Beijing Mab-Works, Inc., PR China
This presentation will share with you IND filing experience with CFDA for two antibody biosimilars and understanding of the regulatory environment in China. The CMC comparability study and critical quality attribute (CQA) analysis strategies will be discussed. Beijing Mab-Works’ in-house platform technology and development strategy for antibody-based therapeutics for China market will also be described.
3:15 From Discovery to QC: Enabling Solutions for Biotherapeutic Research and Development
Martina Bielefeld Sevigny, Ph.D., Vice President & General Manager, PerkinElmer LST
Biologics, being complex bio-molecules, require a wide spectrum of methods to characterize them in order to assure consistent safety and efficacy. In this presentation we will discuss novel technologies based on microfluidics and AlphaLISA showing breakthrough data from detection of residual process contaminants to fast determination of glycosylation patterns.
3:30 Sponsored Presentation
Speaker to be Announced
3:45 Refreshment Break
4:15 Characterization of a Biosimilar for Development in China
Joanne Sun, Ph.D., Executive Director, Quality and Analytical Development, Innovent Biologics, Inc., PR China
4:45 Analytical Characterization of mAbs for Biosimilar Development in China
Jia-Ming Yang, Ph.D., Senior Scientist, Analytical Quality Control, Livzon MabPharm, Inc., PR China
Demonstrating similarity to an innovator is critical and challenging for biosimilar development, because of the intrinsic complexity and heterogeneity of bio-molecule. This presentation will show the successful application of our analytical platform in the characterization of biosimilars. Variations between the biosimilar and innovator will be systematically analyzed in terms of molecular structure, bioactivity and their potential correlations. This could improve the understanding of similarity and process controls.
5:15 Immunogenicity of Clotting Factors: Predictive Methods and Risk Factors
Matthias Germer, Ph.D., Senior Director, Preclinical Research, Biotest AG, Germany
The most important adverse event in the substitution of coagulation factors in hemophilia patients is formation of inhibitory antibodies. Product, patient and treatment characteristics have now been identified as most relevant risk factors. The in-depth understanding of the immunological response allows us to minimize the patient risk by adequate patient monitoring and adaptation of individualised treatment schemes. Predictive immunogenicity tests might help us to develop unique novel products.
5:45 Welcome Reception in the Exhibit Hall with Poster Viewing