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BioProcess International China Conference & Exhibition

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Process Development and Manufacturing Strategies for Biotherapeutics throughout the Product Lifecycle

August 12-13, 2015 · Grand Hyatt Shanghai · Shanghai, China

Translations

Alternative Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

Agenda

Agenda

Wednesday, August 12, 2015

7:30
Registration and Coffee with Exhibit and Poster Viewing

8:20
Chairman's Remarks
Chengbin Wu, Ph.D., Chief Scientific Officer, President of R&D, Shanghai CP Guojian Pharmaceutical Co. Ltd., China

Keynote Presentations

8:30
Robert Friesen, Ph.D. Exceptional Activities from Multi-specific Biologics using Novel Architectures
Therapeutic Biologics designed to bind to multiple targets drastically alter the landscape of drug development by achieving previously unattainable levels of affinity and specificity. Antibodies and alternative scaffolds that bind to respective antigens individually are being used to create novel architectures capable of manipulating complex biological systems and delivering novel activities that are found only when binding to two or more targets simultaneously. We also engineer properties such as solubility, pharmacokinetics, and Fc effector function that can be critical to the clinical efficacy of a protein therapeutic molecule. This talk will highlight recent examples of how novel architecture of multi-specific biologics can be used to design highly potent molecules with sometimes unexpected activities.
Robert Friesen, Ph.D., Vice President and Global Head of Biologics Research, Biotechnology Center of Excellence, Janssen R&D, LLC (Johnson & Johnson), USA

9:00
Rene Hoet, Ph.D. Innovative Strategies for Antibody Lead Discovery and Optimization at Bayer
This presentation will discuss some of the innovative strategies we are using for antibody lead discovery using in vitro display technologies, high-throughput IgG screening to select functional, biological active antibodies early in the discovery process, phenotypic cell selection and screening to expand the target space and optimization for activity, reducing immunogenicity and improving CMC properties of antibodies.
Rene Hoet, Ph.D., Vice President Global Biologics, Antibody Lead Discovery, Bayer Healthcare, Germany

9:30
Networking Refreshment Break with Exhibit and Poster Viewing

10:10
Chairman's Remarks
H. Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China

Upstream Development:
Cell Line and Cell Culture Processing

10:15
CHO Glycosylation Mutants for Production of Fucose-free and Galactose-free Antibody Therapeutics
Removal of core fucose from IgG1 antibodies is able to increase its affinity for FcgRIII and enhance ADCC. The galactose content of the N-glycans from different antibody products can vary significantly which is a critical quality attribute to batch-to-batch consistency. To address these industry-specific needs, we have created CHO mutants for producing fucose-free and galactose-free antibodies.
Zhiwei Song, Ph.D., Principal Scientist, Expression Engineering, Bioprocessing Technology Institute, Singapore

10:45
Post-translation Modifications of Protein in Cell Culture
This presentation will discuss the mechanics of cell culture process development. It will also provide perspectives on evaluating post-translational modifications of proteins in cell culture and offer new strategies for doing so.
Yanrong Dong, M.D., Senior Scientist/Group Leader, Cell Biology, AlphaMab Co. Ltd., China

11:15
A Robust Platform for High Quality Biosimilar Development
Case Study
Bringing biosimilars market currently requires large investments of money and there are high regulatory hurdles to obtain interchangeability, which biosimilars will need to compete with their reference product on the basis of quality, manufacturing time and cost. This talk will explore how steps in the generation of mammalian cell lines were optimized to make a process more efficient and certain considerations that were taken to balance the titer and stability vs. quality. A case study of our current cost-effective approach that consistently yields clonal lines and upstream culture conditions that result in 2.0 g/L antibody production in 12-day will be presented.
Qiwei Wu, Ph.D., Vice President, Head of Biologics, Haixi Pharmaceutical Inc., China

11:45
Technology Presentation Pall Fortebio Sponsored by

10:10
Chairman's Remarks
Junyan Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical R&D, Genentech, a member of the Roche Group, USA

Analytical and Formulation Strategies

10:15
Assay Improvement for Protein Therapeutics at Clinical Development Stage
Case Study
Assay improvement (or change) is common in the CMC development of biological products, as developers gain a more comprehensive understanding of the product quality and assay performance along the process development from early clinical development to product launch. This presentation will discuss the potential causes triggering assay redevelopment and the considerations for the activities that would be needed to support an assay change at clinical development stage. A few case studies (e.g., HPLC assays) will be used to demonstrate the technical rationale in the assay design as to how technical issues with old assays can be resolved in the new ones. Due to the complexity of biological product development, the solution for each case of assay change has to be product-specific and phase-appropriate.
Weijun Li, Ph.D., Senior Staff Development Scientist, Analytical Development and Support, Global Biological Development, Bayer HealthCare LLC, USA

10:45
Challenges in ADC Formulation Development from Early Stage to Commercialization
Junyan Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical R&D, Genentech, a member of the Roche Group, USA

11:15
Origin, Detection and Control of Aggregates during Protein Formulation
Proteins have highly ordered three-dimensional structure which is critical for its bioactivity. Environmental changes during involved in formulation process may lead to generation of aggregates. Protein aggregates present challenges not only to the manufacturer but also to the patients. The current presentation provides an insight into origin of protein aggregates and how to detect as well as control them during formulation processes using multiple advanced techniques.
Paresh N. Vadgama, Research Scientist, Biotech Division, Lupin Limited, India

11:45
Technology Presentation Opportunity
For more information, please contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com

12:15
Networking Luncheon with Exhibit and Poster Viewing

1:30
Development of a Scale-Up Cell Culture Model Using Multivariate Analysis
Case Study
Since there are geometric differences between scales, bioreactors at manufacturing scale often vary from bench scale performance. Such differences are typically manifested in different cell growth, protein productivity, and/or protein quality. Here, we describe a case study in which a scale up cell culture process model is developed to mimic historical bench scale performance using multivariate analysis. We identify gaps between scales and process adjustments were then implemented at manufacturing scale. This resulted in a successful scaled-up cell culture process.
H. Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China

2:00
Late Breaking Presentation Opportunity
For more information on presentation opportunities in this session, please contact Michael Keenan at mkeenan@ibcusa.com

2:30
Cell Culture and Upstream Processing
Abstract not available at time of print.
Changlin Dou, Ph.D., Deputy General Manager, BoAn Biotechnology Company, A Subsidiary of Luye Pharma Group, China

Quality Control, Quality Assurance and QbD

1:30
Development of qPCR Assay for Mycoplasma Detection in Biopharmaceutical GMP QC
Mycoplasma detection is one of the most time consuming assays in biopharmaceutical GMP QC. It takes twenty eight days with four subcultures; it is very labor intensive and highly costly due to special media required. qPCR is fast, cost efficient, and highly specific. Assay development results with several biopharmaceutical products will be presented. Assay specificity, accuracy, limit of detection, robustness, ruggedness, and most importantly comparability with existing point-to-consider assay will be discussed.
Gene Zhang, Ph.D., Senior Specialist, Quality Control, Bayer HealthCare, USA

2:00
Quality Issues: Inspection Readiness, Documentation, and Training for GMP, Quality Assurance and Operations
In this presentation we review current quality issues experienced by companies in China, focusing on actual examples from FDA records. We explain how many of these issues can be dealt with through proper preparation of documentation and through training. Attendees will have an opportunity to participate in a training example that enhances the learning experience and strengthens retention.
Scott M. Wheelwright, Ph.D., Founder and Principal Consultant, Complya Asia Co., Ltd., China

2:30
QbD Approach to Analytical Method Development and Validation
This presentation discusses the essential concepts associated with method develop including method characterization, risk assessment, robustness, stability and control. Further the presentation demonstrates DOE study design approaches to efficiently meet ICHQ2 and USP 1033 requirements for Method Validation. Best practices and analytical approaches for Specificity, Linearity, Range, Repeatability, Accuracy, Intermediate Precision, Limit of Detection, Limit of Determination and Limit of Blank will be presented.
Thomas A. Little, Ph.D., President, Thomas A. Little Consulting, USA

Technology Workshop

3:00
Solutions for Improving Product Titer and Viral Yields in Biopharmaceutical and Vaccine Production
For over 30 years Kerry has provided novel supplements to help cell culture scientists increase product titer, virus yield and reduce/remove animal components from their media. Kerry's custom designed products and services not only provides manufacturers with enhanced upstream process performance but has the potential to reduce process timelines as well as time to market.
John F. Menton, Ph.D., R&D Director for Cell Nutrition, Kerry

3:30
Networking Refreshment Break with Exhibit and Poster Viewing

Navigating Regulatory Interactions with CFDA and US FDA:
Case Studies and Lessons Learned

4:15
Regulatory Perspectives on CMC and GMP during Different Phases of Biopharmaceutical Development in US
Abstract not available at time of print.
Duu-Gong Wu, Ph.D., Director/Senior Consultant, PPD Regulatory Consulting and Former Deputy Division Director, Division of New Drug Chemistry, US FDA/FDER, USA

4:45
CMC Strategies and Regulatory Considerations for Biobetter Development and Production
Case Study
While biosimilar development represents the first wave, biobetter development through scientific and technical innovations ensues as the next wave of biopharmaceutical development in China. For antibody therapeutics, biobetters are designed to improve safety, efficacy, product stability, and/or convenience of use through humanization, affinity optimization, modulation of Fc effector functions by protein or host engineering, and/or process and formulation changes. Unlike biosimilar development, the focus of biobetter development is not on product comparability, but on demonstration of the superiority of key product characteristics. In China, biobetters with new molecular entities are considered as innovative drug candidates. As such, CMC strategies and regulatory considerations are different from biosimilars. Shanghai JMT-Bio focuses on biobetter and innovative drug development, our approaches and challenges will be discussed with case studies.
Minmin Qin, Ph.D., Chief Technology Officer and Senior Vice President, Shanghai JMT-Bio Inc., China

5:15
Validation Strategies for Adopting Single-Use Bioreactors for Commercial Manufacturing of Biologics in China
Case Study
The Presentation will focus on the regulatory challenges that biologics manufacturers in China are facing for adopting SUBs for commercial manufacturing. It will also provide possible strategies and approaches to overcome those challenges and obtain regulatory approvals in a timely fashion. As a case study, the strategies and approaches adopted and being executed by Henlius Biopharmaceuticals will be introduced.
Scott Liu, President and CEO, Shanghai Henlius Biotech, China

5:45
Close of Day One

Thursday, August 13, 2015

7:45
Registration and Coffee with Exhibit and Poster Viewing

8:25
Chairman's Remarks
Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

Portfolio Updates on Innovative Antibody & Biologics R&D in China

8:30
Discovering and Developing Biologics for Cancer Therapy
Different modalities of biologics such as monoclonal antibodies, antibody-drug conjugates (ADC), immunotoxins and cytokine-mimics have been developed or approved for cancer treatment. This presentation will focus on the discovery and development of our proprietary antibodies targeting the immune checkpoint for unleashing anticancer immunity and a few novel ADCs. The preclinical data of these molecules will be discussed.
Weikang Tao, M.D., Ph.D., CEO, The R&D Center, Shanghai HengRui Medicine Co. Ltd., China

9:00
Developing Therapeutic Antibodies in China: Biosimilars and Innovative Biologics
The success of CP GuoJian, a China-based antibody development company, has demonstrated the fast growth of biologics R&D in China over the past 10 years. China has its unique strength in discovery and clinical research, and the bioprocess and manufacturing industry has matured rapidly. Although the earlier antibody development focused mostly on biosimilars, many companies are moving towards developing second generation and novel biologics products. This talk will address innovative biologics development capabilities and pipeline strategies at CP Guojian, including our work with ADCs and other modalities.
Chengbin Wu, Ph.D., Chief Scientific Officer, President of R&D, Shanghai CP Guojian Pharmaceutical Co. Ltd., China

Keynote Presentation

9:30
Sherry Guo, Ph.D. Analytical Control System Strategy from Phase I to Post Approval
A risk-based phase-appropriate analytical control system strategy for biologics products will be discussed and illustrated by examples of control systems in clinical and BLA stages. Practical approaches and risk assessment system following ICH guidance Q8, Q9 and Q9 will also be shared.
Sherry Guo, Ph.D., Head, Global MMTech Analytical Chemistry and Life Cycle Management, Biologics QC Network (PTQBQ), F. Hoffmann-La Roche Ltd., USA

10:00
Networking Refreshment Break with Exhibit and Poster Viewing

Downstream Development:
Recovery & Purification

Chairperson: Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

10:30
Purification Process Development for Mammalian and Microbial Biotechnology Drugs
The presentation will address factors, similarity and differences to consider for successful recovery and purification process development for mammalian or microbial-based biotechnology therapeutics manufacturing during the clinical development to commercial phase. The focus will be on ensuring manufacturing continuum from Phase 1 to Phase 3 clinical to product commercialization.
Suketu Desai, Ph.D., Vice President, Biologics Development, Drug Substance and Drug Product, Allergan, Inc., USA

11:00
Late Breaking Presentation Opportunity
For more information on presentation opportunities in this session, please contact Michael Keenan at mkeenan@ibcusa.com

11:30
Protein A: The Untold Story
Protein A is not as simple as it has been considered. Chromatin heteroaggregates accumulate on the resin surface during loading; interfere with pore access, and depress binding capacity. IgG is conformationally modified by protein A at this stage. Elution conditions maintain the conformationally modified form of IgG, promote contaminant leaching, and promote associations that cause aggregate formation and loss of IgG. pH neutralization of eluted IgG dissociates it from leached chromatin and promotes formation of chromatin particles that create turbidity.
Richard Nian, Ph.D., Research Scientist, Downstream Processing Group, BioProcessing Technology Institute, Singapore

12:00
Technology Presentation Opportunity
For more information, please contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com

Biomanufacturing, Facility Readiness and GMP Compliance

Chairperson: Wen Ryan, Ph.D., Vice President of Technical Operations, Livzon Mabpharma, Inc., China

10:30
GMP Manufacturing of Antibody-drug Conjugates (ADCs)
MabPlex has established an ADC manufacturing facility that includes GMP production units for antibody expression, small molecule synthesis, ADC conjugation, and filling/finishing. We developed various processes and quality standards to ADC drug manufacturing in large scale and have already supported an IND filing with CFDA for an innovative ADC drug.
Qibin Liang, Chief Operation Officer, MabPlex International, China

11:00
Quality of Technical Operations
The therapeutic values of biologics have been increasingly recognized by the Chinese healthcare community. With the advent of biosimilars, the economical values have become ever more compelling. To realize the full medical potential, there must be genuine appreciation for the risks and benefits of biologics in that the safety and efficacy of a drug go hand in hand with Quality of Technical Operations - including Process Development, Clinical Manufacturing, Commercial Manufacturing, etc. This presentation will discuss the integration of key operational elements to enhance Quality of Technical Operations with an emphasis on biosimilarity and comparability.
Wen Ryan, Ph.D., Vice President of Technical Operations, Livzon Mabpharma, Inc., China

11:30
Presentation Title TBA
Speaker TBA, GE Healthcare

12:00
Technology Presentation Opportunity
For more information, please contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com

12:15
Networking Luncheon with Exhibit and Poster Viewing

Virus Safety and Viral Clearance

1:30
Technology Development in Bioreactor Viral Safety
Abstract not available at time of print.
Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

2:00
Viral Clearance Validation with Ready-to-Process Single Use Chromatography Columns
Risk management for viral clearance goes along with the process chain. For removal of adventitious viruses derived from host cell, raw materials, employees and HVAC systems, in DSP different clearance steps such low pH, nano-filtration and chromatography steps have to be validated by spiking different types of model viruses. Preferentially ready-to-process single use chromatography columns are used as consistent and standardized down scale models for the commercial process. All these clearance steps have to be considered in early process development.
Rolf G. Werner, Ph.D., Professor, Industrial Biotechnology, University of Tuebingen, Germany

2:30
Downstream and Viral Safety Considerations for mAb Therapeutics Production
Development and commercialization of mAb innovative and biosimilar therapeutics is becoming a clear trend in the pharmaceutical industry because of patent expiration and clinical safety/efficacy profile of these blockbuster molecules and their extremely huge market potential globally. Recent clinical validation and demonstration of immunotherapeutic molecules such as PD-1 and PD-L1 mAbs illustrated much longer patient survivals, indicating the excellent potential of these molecules in oncology at a low dose with a high potency. Downstream processing and viral safety are key considerations after the right clone is selected for mAb production. In this presentation, after a brief introduction of global trends of mAb therapeutics and basic requirements of clone selection for commercial usage, challenges of downstream process development for mAb production is discussed. Strategic approaches for viral clearance are presented while current VC practices of Chinese CFDA and US FDA requirement is compared.
Joe Zhou, Ph.D., CEO, Genor, Walvax Bio Group and Visiting Professor, Peking University, China

3:00
Technology Presentation Opportunity
For more information, please contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com

Biosimilar Development: Regulatory Experiences and Risk-based Strategies

1:30
Biosimilar Research and Development
Abstract not available at time of print.
Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China

2:00
Practical Quality and Comparability Considerations during Development of Biosimilar/Biobetter Antibody Therapeutics in China
Abstract not available at time of print.
Feng Li, Ph.D., Chief Executive Officer, Beijing Mab-Works, Inc., China

2:30
Case Study on mAb Biosimilar
Case Study
Abstract not available at time of print.
Zheru Zhang, Ph.D., CEO, Shanghai JMT-bio Inc., China

3:00
Technology Presentation Opportunity
For more information, please contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com

3:30
Networking Refreshment Break with Poster and Exhibit Viewing

4:00
Risk-targeted Biosimilar Development and Management
Quality and safety of drugs is a crucial topic for both the public and pharmaceutical companies, especially when biologics and biosimilars become the mainstream of drug development. This presentation will review the quality and safety risks associated with biologics and analyze their reasons, risk monitoring strategies and control processes. A risk-targeted biosimilar development and management strategy is proposed.
Jinhai Shi, M.D., Ph.D., Vice President, Tianjin Joint Academy of Biomedicine (TJAB), China

Panel Discussion:

4:30
Partnering Strategies to Advance R&D in China and Asia
  • Collaboration strategies along the R&D value chain
  • Collaboration models (risk sharing, co-development, options, etc.)
  • Innovation strategies to boost China as a global R&D center
  • The role of MNCs in developing China as a global R&D source
  • China as a leading global R&D center in 2025: Reality or fiction?
Moderator:
Yariv Hefez, Vice President Business Development, Portfolio Management, Strategy and Partnering Biosimilars Unit, Merck
Panelists:
Scott Liu, President and CEO, Shanghai Henlius Biotech, China
Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China

5:30
Close of Conference

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