7th Edition  Trade Show

BioProcess International Conference & Exhibition China

"To bring China and the rest of the world together to explore the missing gaps in China's development."
BioProcess International Conference & Exhibition China is a much awaited medical show which will bring forth true advancement of Cell Line Engineering, Cell Culture, Media Development and at the same time concentrates on Characterization and Comparability for Biologics and Biosimilars. This is a two day medical show which will be taking place at Grand Hyatt Shanghai situated in the city of Shanghai. BioProcess International Conference & Exhibition China highlights the techniques and methods of bioprocesses and focuses on developing the research and scientific departments involved in cell line engineering. The exhibitors provide ample information on novel biologics and vaccine as well as different aspects of clinical trials will also be discussed by the experts who have years of experience in this industry.


07:30 AM - 05:45 PM (Aug 12) (General)
07:45 AM - 05:00 PM (Aug 13) (General)

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5000 - 20,000

100 - 500 Exhibitors Estimated Count

Category & Type

Trade Show
IT & Technology


12 - 13 Aug 2015 7th Edition
19 - 20 Aug 2014 6th Edition
20 - 21 Aug 2013 5th Edition
21 - 22 Aug 2012
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Schedule & Agenda

Wed, 12 Aug07:30 AM - 08:20 AMRegistration and Coffee with Exhibit and Poster Viewing
Wed, 12 Aug08:20 AM - 08:30 AMChairman's Remarks
Chengbin Wu, Ph.D., Chief Scientific Officer, President of R&D, Shanghai CP Guojian Pharmaceutical Co. Ltd., China
Wed, 12 Aug08:30 AM - 09:00 AMRobert 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
Wed, 12 Aug09:00 AM - 09:30 AMRene 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
Wed, 12 Aug09:30 AM - 10:10 AMNetworking Refreshment Break with Exhibit and Poster Viewing
Wed, 12 Aug10:10 AM - 10:15 AMChairman's Remarks
Junyan Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical R&D, Genentech, a member of the Roche Group, USA
Wed, 12 Aug10:10 AM - 10:15 AMChairman's Remarks
H. Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China
Wed, 12 Aug10:15 AM - 10:45 AMAssay Improvement for Protein Therapeutics at Clinical Development Stage
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
Wed, 12 Aug10:15 AM - 10:45 AMCHO 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
Wed, 12 Aug10:45 AM - 11:15 AMPost-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
Wed, 12 Aug10:45 AM - 11:15 AMChallenges 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
Wed, 12 Aug11:15 AM - 11:45 AMDevelopment 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
Wed, 12 Aug11:45 AM - 12:15 PMfortebio New Tools and Methods for Rapid, Label-Free Characterization in Biotherapeutic Drug Development
Bio-Layer Interferometry (BLI) from Pall ForteBio has gained a significant reputation as one of the leading technologies of label-free analysis for protein characterization and biotherapeutic drug development. New tools and methods have been developed for further characterization, including Fc-gamma receptor binding, epitope binning, and assessing host-cell protein contamination (HCP) in downstream bioprocessing. This presentation will provide a brief overview of these recent developments in BLI that aid in the rapid development of biotherapeutics.Dominic Andrada, Senior Product Manager, ForteBio - A Division of Pall Life Sciences
Wed, 12 Aug12:15 PM - 01:30 PMNetworking Luncheon with Exhibit and Poster Viewing
Wed, 12 Aug01:30 PM - 02:00 PMQuality 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
Wed, 12 Aug02:00 PM - 02:30 PMDevelopment of a Scale-Up Cell Culture Model Using Multivariate Analysis
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
Wed, 12 Aug02:30 PM - 03:00 PMCell 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
Wed, 12 Aug03:00 PM - 03:30 PMKerry Inc 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
Wed, 12 Aug03:30 PM - 04:15 PMNetworking Refreshment Break with Exhibit and Poster Viewing
Wed, 12 Aug04:15 PM - 04:45 PMRegulatory Perspectives on CMC and GMP during Different Phases of Biopharmaceutical Development in US
CMC and GMP are two integral parts of a drug development program. The current GMP law and regulations, however, do not provide any guidance/guideline on the specific requirements during different phases of biopharmaceutical development. To complicate the situation further, both CMC reviews along with GMP inspections in US for biopharmaceuticals are currently performed by different organizations under different laws and regulations, depending on the product categories. The presentation will focus on CMC and GMP during different phases of biopharmaceutical development in US and discuss their differences for products regulated under different laws and marketing applications.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
Wed, 12 Aug04:45 PM - 05:15 PMCMC Strategies and Regulatory Considerations for Biobetter Development and Production
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
Wed, 12 Aug05:15 PM - 05:45 PMValidation Strategies for Adopting Single-Use Bioreactors for Commercial Manufacturing of Biologics in China
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
Wed, 12 Aug05:45 PM - 05:45 PMClose of Day One
Thu, 13 Aug07:45 AM - 08:25 AMRegistration and Coffee with Exhibit and Poster Viewing
Thu, 13 Aug08:25 AM - 08:30 AMChairman's Remarks
Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA
Thu, 13 Aug08:30 AM - 09:00 AMDiscovering 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
Thu, 13 Aug09:00 AM - 09:30 AMDeveloping 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
Thu, 13 Aug09:30 AM - 10:00 AMSherry 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
Thu, 13 Aug10:00 AM - 10:30 AMBiomanufacturing, Facility Readiness and GMP Compliance
Thu, 13 Aug10:00 AM - 10:30 AMDownstream Development & Viral Safety
Chairperson: Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA
Thu, 13 Aug10:00 AM - 10:30 AMNetworking Refreshment Break with Exhibit and Poster Viewing
Thu, 13 Aug10:30 AM - 11:00 AMProtein 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
Thu, 13 Aug10:30 AM - 11:00 AMGMP Manufacturing and Quality Control 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
Thu, 13 Aug11:00 AM - 11:30 AMQuality 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
Thu, 13 Aug11:00 AM - 11:30 AMTechnology 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
Thu, 13 Aug11:30 AM - 12:00 PMDevelopment of a Robust Antibody Drug Conjugation Process - A Case Study
ImmunoGen develops conjugates consisting of proprietary derivatives of the cytotoxic agent maytansine attached to tumor-targeting antibodies. The process for producing these conjugates is key to reliable achievement of essential product attributes. We will present data on the development of production processes that consistently and cost-effectively achieve necessary product attributes.Wenjie Cheng, Ph.D., Principal Scientist, Process Science and Engineering, Immunogen, Inc., USA
Thu, 13 Aug11:30 AM - 12:00 PMViral 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
Thu, 13 Aug12:00 PM - 12:30 PMPresentation Title TBA
Speaker TBA, GE Healthcare
Thu, 13 Aug12:00 PM - 12:30 PMDownstream 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
Thu, 13 Aug12:30 PM - 01:30 PMNetworking Luncheon with Exhibit and Poster Viewing
Thu, 13 Aug01:30 PM - 02:00 PMBiosimilar Research and Development
Abstract not available at time of print.Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China
Thu, 13 Aug02:00 PM - 02:30 PMPreclinical Development of EGFR Antibody for Colon Cancer
The EGFR monoclonal antibody, vectibix, has been used to treat colon cancer. We have developed its biosimilar antibody BD1001and completed a variety of head to head comparison with vectibix including sequencing, physicochemical characterization,efficacy, PK and toxicology studies. The cFDA Investigational New Drug has been applied in 2014.Yunpeng Su, D.Phil., Scientific Director, NovoMab Biopharmaceutical, Inc., China
Thu, 13 Aug02:30 PM - 03:00 PMMaxCyte - Flow Transfection Systems Shortening the Antibody Development Timeline with Scalable, High-yield Antibody Production via Flow Electroporation
Developing novel biotherapeutics requires the rapid production of gram-level quantities of antibodies. In this presentation, data developed with MaxCyte's flow electroporation, closed, single-use, cGMP-compliant system will demonstrate the cost-effective production of multiple grams of antibodies, bispecifics, and non-antibody like recombinant proteins recombinant proteins following a single transient transfection. Data will demonstrate the ability of MaxCyte flow electroporation to produce antibody titers up to 2.7 g/L as well as its scalability with CHO cells, HEK293 cells, insect cells, and other commonly used cells in bioproduction. The data also will show the production of a high producing stable CHO pool and the rapid generation of high-yield stable cell lines with at titer of 5.7 g/L within 6-8 weeks of transfection.Weili Wang, Ph.D., Principal Scientist, Protein Production, Technical Applications, MaxCyte, Inc., USA
Thu, 13 Aug03:00 PM - 03:30 PMNetworking Refreshment Break with Poster and Exhibit Viewing
Thu, 13 Aug03:30 PM - 04:00 PMRisk-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
Thu, 13 Aug04:00 PM - 05:00 PMPartnering 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?Panelists:Scott Liu, President and CEO, Shanghai Henlius Biotech, ChinaLi Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China
Thu, 13 Aug05:00 PM - 05:00 PMClose of Conference

Exhibitors Profile

BioProcess International Conference & Exhibition China will be participated by potential business partners and collaborators, researchers and developers of biosimilars, biobetters, novel biologics and vaccinations, experienced scientists and engineers and lot more. These professionals will interact with the attendees and scholars and discuss about the various issues and development programs.

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