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BioProcess International China Conference & Exhibition

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China's Foremost Event on BioProcessing and Biomanufacturing
中国生物医药研发及生产领域盛况空前的大会

August 19-20, 2014 · Grand Hyatt Shanghai · Shanghai, China

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Alternative Language Options:

  • Japanese
  • Taiwanese
  • Chinese
  • Korean
  • English

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Agenda

Agenda

Tuesday, August 19, 2014

8:00
Registration and Coffee

8:55
Chairwoman's Opening Remarks
Dr. Christel Fenge, Vice President, Marketing Fermentation Technologies, Sartorius Stedim Biotech, Germany

Keynote Presentations

9:00
Wu Jun The Current Situation and Analysis of Facility Design of Biological Products in China
This presentation analyzes the current situation of facility design of biological product in China, highlighting key design factors and methods to achieve the goal of safe, effective and compliant products.
Wu Jun, Executive Development Teacher, China's State Food and Drug Administration (SFDA)

9:30
Case Study
Magnus Jahnsson, MS Risk-Based EU-GMP-Compliant Commissioning and Qualification in a New Chinese Biomanufacturing Facility
Pharmadule is managing the qualification and validation of a Chinese drug maker's new manufacturing facility for biotech and biosimilar products in Shanghai. This talk explores methods for modern quality risk management when there is no R&D-data to support the derivation of parameters and attributes; cultural challenges for both the contractor and Chinese biotech company; what a western consultant needs to do to achieve results; documenting and qualifying according to Western standards; aligning Chinese and international sub-suppliers to meet expectations greater than normal for a domestic Chinese manufacturing facility; overcoming challenges and transitioning to process validation phase.
Magnus Jahnsson, MS, Director of Regulatory Affairs, Quality and Project Management, Pharmadule Morimatsu, Sweden

10:00
Networking Refreshment Break and Opening of Exhibit & Poster Hall

Cell Line Engineering, Cell Culture and Media Development

Harness novel technical and process innovations.

10:40
Chairwoman's Opening Remarks
Dr. Christel Fenge, Vice President, Marketing Fermentation Technologies, Sartorius Stedim Biotech, Germany

Featured Presentation

10:45
New DataCase Study
Wenzhi Tian, M.D. Generation and Process Development of CHO-K1 Cell Line Expressing High Level of Fc-Fusion Protein
Using CHO-K1 cells adapted to suspension culture, the presentation demonstrates how Huabo Biopharm has generated several stable cell lines expressing a recombinant Fc-fusion protein. These cell lines have been extensively characterized for production capacity exhibited as production per cell per day (PCD), genome integration, as well as stability after 30 passages. Using commercial base medium as well as feeding materials, they have also developed culture process in bioreactors at different scale.
Wenzhi Tian, MD, Chief Executive Officer, Huabo Biopharm Co., Ltd., China

11:15
ambr and ambr250: Systems Enabling High Throughput Biologics Development
Once a large molecule has been established as relevant for an indication, teams managing eukaryotic or prokaryotic platforms face diverse challenges in developing the processes needed for manufacturing material for clinical assessment and, ultimately, the commercial phase. Current approaches are limited by infrastructure that requires significant labor input, laboratory space and capital investment. In addition, certain techniques may not consistently predict culture behavior at larger scale. TAP Biosystems' advanced microbioreactor (ambr™) technology has been widely adopted as an effective solution to such problems. In this update, novel applications for ambr will be described; the ambr250 platform will be introduced (offering high throughput automation for groups working with microbial platforms) and recent data will be presented.
Ian Ransome, Director, Asia Pacific, TAP Biosystems, United Kingdom

Analytical Methods and Technologies

Immediately applicable knowledge through method and tool strategies for effective product characterization, process development and analysis, and QC testing.

10:40
Chairman's Opening Remarks
Wei Xu, Ph.D., Principal Scientist, Merck, USA

10:45
Developing a Successful Quality Organization: Changing the Mindset of a Corporation
A consultant specializing in QA and cGMP compliance will take you on an "interactive journey and explore the challenges faced by quality operations in Asia. Success in Quality depends on how we measure it. Firstly, our product must be safe for our patients, which means every batch meets specifications. Secondly, our operations must be the best in terms of cost (lower is better), waste (less is better), staff (well trained with low turnover), and fast (because time is money). To build the high quality organization our company needs and deserves there are several helps we can employ. Foremost among these are GMP regulations. Join us as we take an interactive journey and explore the challenges faced by Quality operations in Asia.
Scott M. Wheelwright, Ph.D., Cofounder and Principal Consultant, Complya Asia Co., Ltd., China

11:15
New DataCase Study
Analytical Strategies for Antibody Drug Conjugates
  • Overcome challenges of analytical method development, characterization and specification setting for ADCs.
  • Gain insights on analytical development for early stage versus late stage.
Gayathri Ratnaswamy, Ph.D., Director, Analytical Formulation Development, Agensys, Inc., USA

11:45
Streamlining Media Design
During the past decade, biopharmaceutical manufacturers have witnessed significant productivity gains that can largely be attributed to developments in cell culture media design. However, a more holistic approach to process development is now emerging with a primary aim of streamlining the entire production process to deliver efficient robust processes that are predictable and deliver a consistent product. This seminar describes how Kerry supports biopharmaceutical manufacturers in the optimization of their upstream process through the use of specifically designed cell culture supplements and feeds.
John Menton, R&D Director, Kerry, USA

12:15
Networking Luncheon with Exhibit and Poster Viewing

1:25
Chairman's Opening Remarks
Weichang Zhou, Vice President of Bioprocess Development, Wuxi AppTec, China

1:30
New DataCase Study
Continuous Culture in the Age of Single-Use
Continuous culture offers a number of advantages, e.g. higher titres and constant culture environment and is the method of choice for challenging therapeutic proteins such as rFVIII, rFVII. We will present our approach to single-use continuous manufacturing, how to deal with typical challenges and share data from case studies up to 2000L scale, discussing innovative control approaches and how to effectively clarify crude harvests.
Dr. Christel Fenge, Vice President, Marketing Fermentation Technologies, Sartorius Stedim Biotech, Germany

2:00
Improvement & Simplification of Fed-Batch Bioprocesses with Chemically Modified Media Components
Xiaoli Li, Ph.D., Field Marketing Manager, Merck Millipore

1:25
Chairman's Opening Remarks
Wei Xu, Ph.D., Principal Scientist, Merck, USA

Featured Presentation

1:30
The Efficacy of Biologics on the Prevention of Postoperative Crohns's Disease Recurrence Based on Network Meta-Analysis
The efficacy of 5-aminosalicylates, immunomodulators and biologics for postoperative prophylaxis of Crohn's disease (CD) recurrence is compared by using a network meta-analytical approach. Biological agents were associated with a large and significant reduction of both endoscopic and clinical recurrence compared with placebo, 5-aminosalicylates, or immunomodulators. Biologics are found to be the most effective medications to prevent CD recurrence.
Zhiping Yang, Ph.D., MD, Doctor, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, China

2:00
Case Study
Apply Size Exclusion Chromatography as Process Analytical Technology (PAT) to Optimize Sialyation during CHO Cell Cultivation
The process analytical technology (PAT) initiative is now more than 10 years old since it began. Many tools and software packages were developed for PAT application in pharmaceutical processes. However, most of these applications were limited to small molecule drugs only. It is challenging for PAT applications to biopharmaceutical industry, especially in the cell cultivation process. It is because there is little study demonstrated that the current PATs are indicative to current quality control (QC) tests. To overcome this challenge, we developed and applied a size exclusion chromatography based PAT during cell cultivation to evaluate the sialic acid content QC test in final product. We also provide a case study on application of this PAT in our process optimization.
H. Fai Poon, MD, Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China

2:30
New DataCase Study
Successful NS0 Cell Culture Process Transfer from Stainless Steel to Disposable Bioreactors at 2000L Scale
Disposable bioreactors have been gaining widespread adoption for pilot and large scale production. Many processes which had been developed and implemented in stainless bioreactors initially are being adopted in disposable bioreactors. In this case study, we will present a successful process transfer from stainless steel to disposable bioreactors at 2000L scale for clinical production of a monoclonal antibody using a NS0-derived cell line from the US to China. This enables us to successfully produce clinical supplies of a monoclonal antibody in China for the first time for global clinical trials.
Weichang Zhou, Vice President of Bioprocess Development, Wuxi AppTec, China

3:00
Networking Refreshment Break with Exhibit and Poster Viewing

Featured Presentation

3:45
New DataCase Study
Yan Luan, Ph.D. Development of Full Human Antibody Drug Targeting Cancer Immune Checkpoint Molecules by Yeast Display
This presentation explores DingFu bio Co.'s latest R&D updates on full human antibody drugs targeting cancer immune checkpoint molecules, and how high throughput Ab production is achieved for several drug candidates.
Yan Luan, Ph.D., Senior Scientist, Research & Development, DingFu bio Co., China

4:15
New DataCase Study
Risk Management of Adventitious Agent Contamination in Upstream Manufacturing Processes
Contamination in upstream processes by adventitious agents, including bacteria, fungi, mycoplasma and viruses, are a reality for the biopharmaceutical industry. They are costly to an organization in many ways: financially, lost time in production, unplanned resource allocations, and elevated compliance risk. This presentation will focus on strategies used for assessing and mitigating the risk of contamination in upstream processes by adventitious agents. A case study will be shared about Biogen Idec's approach on validation of pre-filtration medium hold.
Hang Yuan, Senior Engineer III, Manufacturing Sciences, Biogen Idec, USA

Interactive Panel Discussion:

4:45
Upstream Successes and Lessons Learned
Get insights on more robust cell line, cell culture and media development.
Moderator: Weichang Zhou, Vice President of Bioprocess Development, WuxiApptec, China
Panelists:
Ian Ransome, Director, Asia Pacific, TAP Biosystems, United Kingdom
Wenzhi Tian, MD, Chief Executive Officer, Huabo Biopharm Co., Ltd., China

Featured Presentation

3:45
Amgen's Quality Approach in Asia
An international quality director details the Thousand Oaks, CA-based biopharmaceutical company's methods and strategies for assuring quality of its products and processes for materials sourced from Asia and products sold in Asia.
Richard O'Keeffe, Executive Director, International Quality Asia, Amgen, USA

4:15
New DataCase Study
Mass Spectrometry - an Essential Tool for Characterization of Monoclonal Antibodies during Development
Monoclonal antibodies (mAbs) represent a big portion of therapeutic proteins. Mass spectrometry (MS) coupled with modern separation technologies has become an essential tool in characterization of mAbs within the Quality by Design (QbD) paradigm during development. In this presentation, we use case studies to discuss the application of MS analysis in clone selection, optimization of fermentation conditions, development of purification and formulation. Specifically, simultaneously detect and monitor variants due to incomplete leader sequence processing, accurately determine afucosylation level of N-glycosylation, characterize host cell proteins (HCPs), identify degradation pathways and critical quality attributes (CQAs) will be discussed.
Wei Xu, Ph.D., Principal Scientist, Merck, USA

Interactive Panel Discussion:

4:45
Methods and Strategies for Characterization and Detection
Considerations, strategies and technologies for optimal characterization, comparability and detection; PAT and QbD will also be discussed.
Moderator:
Wei Xu, Ph.D., Principal Scientist, Merck, USA
Panelists:
H. Fai Poon, MD, Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China
Gayathri Ratnaswamy, Ph.D., Director, Analytical Development, Agensys, Inc., USA
Scott M. Wheelwright, Ph.D., Co-Founder and Principal Consultant, Complya Asia, Co., Ltd., China

5:15
Networking Cocktail Reception with Exhibit and Poster Viewing

Wednesday, August 20, 2014

Biosimilar Development and Production

Updates on biosimilar developments with technical case studies and practical advice from thought-leaders.

7:55
Chairman's Opening Remarks
Scott M. Wheelwright Ph.D., Co-Founder and Principal Consultant, Complya Asia Co., Ltd., China

Keynote Presentation

8:00
DQ Wang, Ph.D. Biosimilar mAbs in China - Drivers and Challenges
From a multinational pharmaceutical company's perspective, this presentation discusses current biosimilar development in China particularly focusing on mAbs. It covers the potential market, government policy and regulations, MNC possible entry strategy and a summary with findings and opinions. In each area, both drivers and challenges are discussed in order to provide a true picture of this exciting opportunity in China.
DQ Wang, Ph.D., Director of External Drug Products, Global Biological Development, Bayer HealthCare LLC, USA

8:30
Case Study
Optimal and Consistent Protein Glycosylation in Biosimilar Production
In the development of biosimilars, the biopharmaceutical industry is challenged with driving product quality toward equivalence with the innovative biotherapeutic. The consistent glycoform profile of biosimilars produced through large-scale cell culture is an important criterion that can dictate biological efficacy and ultimately regulatory approval. In addition, there is an increased interest in enhancing cell densities and product yields. This presentation will review advancements in glycosylation control in mammalian cell culture obtained through optimizing basal media, feeds, and process parameters. Case studies discussing recent optimization work utilizing the HyClone™ Metabolic Pathway Design process to, not only, improve product qualities, such as increased afucosylation or tri- and tetra-sialylated glycans, but also to increase cell density and enhance protein productivity, will be presented.
Tariq Haq, MSc., Senior Global Product Manager, HyClone GE Healthcare

9:00
New DataCase Study
Biosimilar Therapeutics in Preclinical/Clinical Development
This presentation provides 1) an overview of biosimilar research 2) key characteristics of biosimilars and 3) a strategy to develop the best process to get the biosimilar production. It also provides the latest research updates on abatacept, belatacept, denosumab, and aflibercept biosimilars
Yanrong Dong, Senior Scientist, AlphaMab Co., Ltd., China

9:30
New DataCase Study
Are Biosimilar Differentiated by Injection Devices?
Biosimilars have been commercialized in the marketplace with limited success. Product differentiation is essential after the biosimilar is deemed to be comparable to the drug product from the innovator. This talk will address several ways of differentiating biosimilars to gain better market acceptance through novel drug delivery technologies. A simple syringe with integrated sharp protection and other injection devices will be discussed as examples. The audience will learn the importance of and options for differentiating their biologics.
Robin Hwang, Ph.D., Owner and Director, ICP Consulting Corp., USA

10:00
Networking Refreshment Break with Exhibit and Poster Viewing

10:30
New DataCase Study
Novel Approach to Monitoring MAB Comparability Using SPR, DSC and 2D-DIGE
To ensure comparability of biotherapeutics, analysis of important quality attributes throughout the entire process and final product is essential. Here we report on a novel approach to verify structural integrity of monoclonal antibodies by analyzing binding characteristics of interactions with structure-sensitive reagents. The presented method offers an interesting tool for monitoring structural integrity of biotherapeutics during upstream and downstream processing.
Dr. Fredrik Sundberg, Global Director, Protein Analysis, GE Healthcare Life Sciences, Sweden

11:00
New DataCase Study
Applying QbD Concept in Process Development for Biosimilars
Establishing biochemical comparability to original drugs is a challenging yet an essential part of the process development for biosimilars. This presentation uses a case study to speak to the challenges in the process development of biosimilars and how the QbD concept may be applied as part of the strategies to address the issues.
Yuefeng Lu, Ph.D., Vice President, Process Development, AskGene Pharma Inc., USA

Interactive Panel Discussion:

11:30
Developing Biosimilars in China and Beyond
  • Regulatory considerations, comparability, quality control and commercial viability.
  • Operational and clinical development considerations and critical investment options.
  • PAT & QbD.
  • What are the key issues with developing biosimilars in the Chinese market?
Moderator:
DQ Wang, Ph.D., Director of External Drug Products, Global Biological Development, Bayer HealthCare LLC, USA
Panelists:
Yanrong Dong, Senior Scientist, AlphaMab, Co. Ltd., China
Robin Hwang, Ph.D., Owner and Director, ICP Consulting Corp., USA
Yuefeng Lu, Ph.D., Vice President, Process Development, AskGene Pharma Inc., USA
Dr. Fredrik Sundberg, Global Director, Protein Analysis, GE Healthcare Life Sciences, Sweden

12:00
Networking Luncheon in the Exhibit and Poster Hall

Innovation Spotlight

1:10
Innovative raw material management and product design strategy for enhanced quality, assurance of supply, validation & change control of single-use systems. – New Flexsafe Bag Family Launch
Jean-Marc Cappia, Group Vice President Marketing & Product Management, Fluid Management Technology, Sartorius Stedim Biotech

Biomanufacturing, Facilities and GMP Compliance

Innovations and applications of flexible, single-use and stainless steel technologies.

1:55
Chairman's Opening Remarks
Lars Dreesmann, Ph.D., Executive Director, Upstream Manufacturing & Tech Transfer, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

2:00
Pre-Packed Disposable Chromatography Columns, Expanding the Benefits of Disposable Manufacturing to Downstream Processing at Large Scale
The adoption of disposable and single use manufacturing products, like SUBs for fermentation has helped reduce the complexity of manufacturing process in many ways including eliminating the need for complex SIP & CIP procedures. The closed system design of these disposable systems also creates a barrier isolating the process flow path from the operators for added security. This presentation will review how disposable technologies have made manufacturing globalization easier and less costly, beyond the well understood impact of SUBs this talk will focus on innovative new disposable technology for downstream chromatography processes, introducing the new OPUS® pre-packed disposable columns.
Steve Tingley, Vice President, BioProcessing Sales & Marketing, Repligen, USA

2:30
Improving Gas-Liquid Mass Transfer Efficacy in a Single-Use Bioreactor
A new sparging technology offering, the Drilled Hole Sparge (DHS), was evaluated with respect to O2 delivery, CO2 stripping, reducing risk of cell damage, and minimizing foam generation. The evaluation was performed using precision MFCs, a high speed camera, behavior modeling, and CO2 and O2 kLa performance analysis (dynamic method) in order to enhance sparger system performance in Thermo Scientific™ Single-Use Bioreactors (S.U.B.s) from 50L to 2000L. The novel sparge design was created that achieves consistent sparging behavior across all system sizes and is capable of accommodating a wide array of sparging demands while maintaining minimal risk of cell damage.
Spencer Parkinson, Senior BioProduction Market Manager, Thermo Scientific Single Use Technologies

3:00
Last Chance for Exhibit and Poster Viewing

3:30
New DataCase Study
Transfer and Implementation of a New Process, Combining Single-Use and Stainless Steel: A Successful Case Study
Fitting a broad variety of process formats in an existing multi-product facility is quite a challenge. When transferring a late stage project into a commercial plant, comparability and timelines are critical, too. Combining disposables and stainless steel is one option to face these requirements. We will present a case study showing how this hybrid operating mode strategy was implemented.
Lars Dreesmann, Ph.D., Executive Director, Upstream Manufacturing & Tech Transfer, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

4:00
How to Rapidly Enable Flexible Biomanufacturing at the Site of Your Choice
The burden of chronic diseases in a growing and ageing population is driving up the global demand for monoclonal antibodies. By attending this presentation, you will discover how our FlexFactory™ biomanufacturing platform enables you to quickly increase or build production of biomolecules such as monoclonal antibodies and vaccines. Based on single-use bioprocessing equipment from cell culture to bulk product formulation, FlexFactory is a centrally automated production train that can be tailored to fit a new or existing facility within nine to 12 months.
Jeff Wang, Business Development Manager, Enterprise Solutions, GE Healthcare Life Sciences, China

4:30
New DataCase Study
Single-Use Technologies for Biologics Production
Explore the pros and cons of single-use technology through case studies on solutions for therapeutic monoclonal antibody and protein production.
Ting Chen, Ph.D., Senior Scientist, Bioprocess, AlphaMab Co., Ltd., China

5:00
Close of BPI China

Formulation and Delivery

Overcome challenges in formulation and device integration for safe and effective target doses and timely market delivery.

1:55
Chairman's Opening Remarks
Peter Tunon, Vice President & Marketing, Natrix Separations Inc., USA

2:00
Case Study
The First Integrated Plastic Pre-Filled Safety Syringe
See the benefits of pre-filled syringe that is break-resistant, free of heavy metals, and features an integrated safety system.
Robin Hwang, Ph.D., Owner and Director, ICP Consulting Corp., USA

Downstream Processing and Purification/Viral Safety

Immediately applicable methods and technologies for improved downstream economics.

Featured Presentation

2:30
New DataCase Study
Viral Safety Measures in Downstream Processing
For removal of potential adventitious viruses contaminations derived from host cell, raw materials, employees and HVAC systems, different clearance steps have to be incorporated into the downstream process, such low pH, UV light, nano filtration and chromatography steps. The clearance of impurities in single purification steps has to be validated for the individual, product specific downstream process by spiking of about 10x8 particles of model viruses per ml to the process. Single stranded and double stranded RNA and DNA viruses have to be selected according to their size, enveloped and non enveloped and resistance to heat, pH and detergence. Also emerging viruses, which might cause a risk in future should be considered. Dependent on the method and the model virus the log reduction for each single step is in the range of 3 to 8 log. Anion exchange chromatography resins as gels or monoliths or membranes, low pH inactivation for 40 minutes and nano filtration are the most effective clearance steps. All these clearance steps have already to be considered in early process development and validated in downscale models. In case of viral clearance preferentially single use material should be used in filtration and chromatography.
Ingrid Rapp, Ph.D., CEO, Labor Dr., Merk & Kollegen, Germany

3:00
Last Chance for Exhibit and Poster Viewing

3:30
Advanced Hydrogel Membrane Chromatography Platform Enabling Flexible, High Productivity, Single-use (Per Batch) Downstream Processing of Biologics
As biopharmaceutical production shifts to a "flexible facility" manufacturing model, the limits of current downstream technologies combined with increased upstream productivity has led to a manufacturing bottleneck. A new single-use (per batch) hydrogel membrane chromatography platform with high dynamic binding capacity and resolution promises greater flexibility and economic effectiveness. This presentation will review recent progress, and include antibody purification case studies.
Peter Tunon, Vice President Sales & Marketing, Natrix Separations, Inc. Sponsored by

4:00
Continuous Chromatography, a Multi-Angle Solution to Drive the mAb Capture Step Costs Down
Continuous chromatography is well established in small therapeutic molecule industries where regulatory approved processes have been running for decades at commercial-scale. The Biopharmaceutical industry is now willing to apply this know-how to streamline biologic purification and drive manufacturing costs down. Sequential Multi-Column Chromatography (SMCC) is gaining interest within the industry, enabling significant increases in purification productivity (4-5 folds) and reducing operational expenses, especially protein-A media consumption for monoclonal antibodies capture. A detailed explanation of SMCC principles will be given along with impact on total cost of ownership. In addition, a case study will be detailed to illustrate the implementation of SMCC for the capture of a monoclonal antibody on a protein A media.
Dr. Yvan Ruland, Technology Manager, Asia Operations, Novasep Asia, China

4:30
New DataCase Study
Improved Process Economy with Non-Column Purification of Monoclonal Antibodies
Protein A in columns has been proven effective as a capture step for therapeutic IgG, but it imposes a productivity bottleneck that compounds its already-substantial expense. In this study, we show data from new clarification methods that enable a number of non-protein A capture alternatives, including non-column formats. Data include results from a magnetic nanoparticle version of steric exclusion chromatography that achieves 1000 times higher capacity per mL of particles than protein A in columns. We also show data from a breakthrough convection-based system that supports 10-fold lower host protein, aggregate and DNA content, plus 10-20% higher IgG recovery compared to 3-step protein A platforms. And it achieves these results with two thirds less water than current protein A platforms.
Gan Hui Theng, Ph.D., Research Fellow, Downstream Processing, Bioprocessing Technology Institute, A*STAR

5:00
Close of BPI China

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