BioProcess International™ China
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Agenda
Main Conference: Monday | Tuesday | Wednesday | Workshops: Wednesday
8:00
Registration Begins
Keynote Presentations
8:30
Chairperson's Opening Remarks
Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc., USA
Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc., USA
8:40
Paving the Critical Path to Innovation in Biopharmaceutical Manufacturing: Opportunities and Challenges Posed by the Emerging Global Biosimilar RegulationsThis presentation will review the evidentiary standards for biosimilars in Europe and then reason how the US FDA could address critical open questions on interchangeability of biosimilar products. From this review and reasoning the potential impact of biosimilar regulation on the overall new drug development process will be provided.
Ajaz Hussain, Ph.D., Vice President, Biological Systems, R&D, Philip Morris International Global Services, USA
9:20
Boehringer-Ingelheim's Biopharmaceutical Strategic Initiatives for Growth in Emerging MarketsAbstract not available at time of print.
Rolf G. Werner, Ph.D., Corporate Senior Vice President, Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH, Germany
10:00
Comparability of Biologics and its Relationship to Biosimilars DevelopmentEstablishing product comparability as a consequence of the introduction of changes to an established manufacturing process of a biotech product has become a routine procedure in many cases. On the basis of established product experience, historical databases, extended characterization data as well as risk assessments product comparability with regard to quality safety and efficacy can be demonstrated between pre- and post change material. Based on specific examples points to consider for comparability exercises will be discussed. Last but not least the applicability and limitations of these concepts on the development strategies for biosimilars will be discussed.
Thomas Schreitmueller, Ph.D., Head, Health Authority Policy & Strategy Biologics, F. Hoffmann-La Roche Ltd., Switzerland
10:40
Networking Refreshment Break with Exhibits & Poster Viewing
Developing a Biopharmaceutical Business in China
11:15
Case
Study
Starting, Qualifying and Licensing a New Facility for Biologic ProductionStudy
A case study will be presented on the startup, qualification and licensing of a new facility for biologics production in record time. This presentation will also discuss the transfer of an existing commercial bacterial-derived process, some of the challenges faced, and the risk control strategies that have been used to manage the risk.
Harry Lam, Ph.D., Senior Director, Biologics Manufacturing Science & Technology, Roche Technical Operations, Singapore
11:40
Case
Study
Outsourcing & Manufacturing Therapeutic Antibodies in China - CMO Case StudiesStudy
In the past ten years, outsourcing the efforts in research and development in particular to Asian countries has evolved from an idea to a validated business option to facilitate the drug development. Are we going to see a repeat of such similar evolution in contract manufacturing to solve the bottleneck for biologics development? Even though it still needs to be validated over time, we have seen an increasing number of business organizations in Asian countries claiming biologic manufacturing capabilities and capacities. Services and partnerships from and with these contract manufacturing organizations (CMO) are available options to potentially shorten the time for drug development processes and to lower the initial investment and risk. This may be even more important for companies in developing bio-similars or FOBs. Taking China as an example, there are a handful of biologic drugs filed for clinical development as well as in trials already. These developments include products from both domestic and international pharmaceutical companies. We will give an overview on CMO development in China and provide real case studies for discussion.
Lei Sun, Ph.D., President of Manufacturing, AutekBio, China
12:05
Case
Study
Reducing Risk in Operating in a Different CultureStudy
Every day it seems more companies are expanding their business to new countries, building partnerships and extending supplier relationships in ever multiplying locations. As we move into new regions and broaden our involvement with new cultures we increase our risk beyond the standard issues of supply and quality. We open opportunities for misunderstanding, miscommunication and unintended consequences. How we handle these risks and correct mistakes reflects on us professionally, on our companies and may determine the success or failure of our project. Join us as we review case studies and learn from the mistakes of others.
Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc., USA
12:30
Designing around the Patents of Others - Examining the Freedom to Operate Issues in Bioprocessing
Scientists today are continuously monitoring the literature (scientific and patent) and then coordinating with their inside and outside patent counsel to determine if they can use certain materials and/or methods in their processes (such materials or methods may be patented by others). As Asian countries increase and improve their patent systems and as collaborations with US and EU continue to increase, these issues are very timely.
Janet McNicholas, Patent, IP, K&L Gates, USA
Anne Dollard, Associate General Counsel, Takeda San Francisco, USA
Scientists today are continuously monitoring the literature (scientific and patent) and then coordinating with their inside and outside patent counsel to determine if they can use certain materials and/or methods in their processes (such materials or methods may be patented by others). As Asian countries increase and improve their patent systems and as collaborations with US and EU continue to increase, these issues are very timely.
Janet McNicholas, Patent, IP, K&L Gates, USA
Anne Dollard, Associate General Counsel, Takeda San Francisco, USA
1:00
Networking Luncheon with Exhibits & Poster Viewing
Development of Novel Proteins/Biosimilars/Bio-Betters
2:00
Chairperson's Opening Remarks
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals, China
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals, China
2:10
KH902, a Novel Product for Ocular Diseases
KH902 is a novel, soluble vascular endothelial growth factor receptor decoy that specifically blocks and inhibits VEGF and placental growth factor. Clinical studies have demonstrated that KH902 safe and well-tolerated. Although the number of patients was small, bioactivity of KH902 was established with improvements in visual acuity, reduction in central retinal thickness, and a decrease in choroidal neovascularization area in patients with CNV due to exudative age-related macular degeneration.
De-Chao Yu, Ph.D., Chief Executive Officer, Kanghong (Chengdu) Pharmaceutical Co. Ltd, China
KH902 is a novel, soluble vascular endothelial growth factor receptor decoy that specifically blocks and inhibits VEGF and placental growth factor. Clinical studies have demonstrated that KH902 safe and well-tolerated. Although the number of patients was small, bioactivity of KH902 was established with improvements in visual acuity, reduction in central retinal thickness, and a decrease in choroidal neovascularization area in patients with CNV due to exudative age-related macular degeneration.
De-Chao Yu, Ph.D., Chief Executive Officer, Kanghong (Chengdu) Pharmaceutical Co. Ltd, China
2:40
High-Effective Antibody Production Applied by Novel Bioreactor
Harbin Pharmaceutical Group Biological Engineering Co., Ltd. based on a novel mechanism of excited oxygen flow bio-reactor and efficient expression system in mammalian cells of two key technologies for the development of antibody drugs, has successfully built the industrialization of antibody drug technology platform.
Huicheng Li, Ph.D., President, Harbin Pharmaceutical Group Biological Engineering Co., Ltd., China
Harbin Pharmaceutical Group Biological Engineering Co., Ltd. based on a novel mechanism of excited oxygen flow bio-reactor and efficient expression system in mammalian cells of two key technologies for the development of antibody drugs, has successfully built the industrialization of antibody drug technology platform.
Huicheng Li, Ph.D., President, Harbin Pharmaceutical Group Biological Engineering Co., Ltd., China
3:10
Networking Refreshment Break with Exhibits & Poster Viewing
3:45
Human Antibodomics' Approach to Development of Bio-better and Novel Antibody Products
Human Antibodomic developed an antibodomic program that leads to discovery and development of novel antibody targets and Bio-better and Novel antibody Products. New technologies are increasing the speed and efficiency of human antibody development. One novel antibody targets (ARB) and its novel antibody products (Arbamab) as well as one bio-better antibody product against TNF (Haidamab) will be discussed.
Jian Ni, Ph.D., M.D., Chief Executive Officer, Human Antibodomics (SIP) Inc., China
Human Antibodomic developed an antibodomic program that leads to discovery and development of novel antibody targets and Bio-better and Novel antibody Products. New technologies are increasing the speed and efficiency of human antibody development. One novel antibody targets (ARB) and its novel antibody products (Arbamab) as well as one bio-better antibody product against TNF (Haidamab) will be discussed.
Jian Ni, Ph.D., M.D., Chief Executive Officer, Human Antibodomics (SIP) Inc., China
4:15
Protein Engineering to Design BioBetter Drugs by Molecular Evolution
Molecular evolution has been becoming a new powerful tool to modify protein structure and improve protein function and commercial values. To develop novel therapeutic mAbs targeting critical diseases including but not limited to cancers, Programmed Artificial Evolution (PAE) technology was developed by combining an ultra-scale fully-human antibody library with artificial molecular evolution method. The artificial evolution method introduced key-amino acid scanning and GCR (Goose array CDR-in Random) mutation design to improve mutation efficiency and PCR procedure. mAbs with affinity at picomolar level have been developed by this method for human TNFa, RANKL, CD20 and VEGF. These results show that PAE technology is a useful tool for development of novel therapeutic mAbs with very competitive technical parameters.
Qingfa Liu, Ph.D., Chief Executive Office, Shanghai Programmed Artificial Molecular Evolution Co. Ltd., China
Molecular evolution has been becoming a new powerful tool to modify protein structure and improve protein function and commercial values. To develop novel therapeutic mAbs targeting critical diseases including but not limited to cancers, Programmed Artificial Evolution (PAE) technology was developed by combining an ultra-scale fully-human antibody library with artificial molecular evolution method. The artificial evolution method introduced key-amino acid scanning and GCR (Goose array CDR-in Random) mutation design to improve mutation efficiency and PCR procedure. mAbs with affinity at picomolar level have been developed by this method for human TNFa, RANKL, CD20 and VEGF. These results show that PAE technology is a useful tool for development of novel therapeutic mAbs with very competitive technical parameters.
Qingfa Liu, Ph.D., Chief Executive Office, Shanghai Programmed Artificial Molecular Evolution Co. Ltd., China
Featured Presentation
4:45
New Concepts for More Affordable Manufacturing Facilities for China and Other Emerging Countries
Everybody agrees that Vaccines and Vaccination programs can save many children's lives, especially in the emerging countries. For that reason, it is important to develop and manufacture high quality vaccines at an affordable cost. The concept of using modular and standardised "state of art" manufacturing facilities - developed by NNE Pharmaplan - makes it possible to set up such facilities much faster and to a lower cost. Combining this design concept by a turn key project strategy will make it possible for emerging countries to set up their own vaccine production at a very attractive cost.
Klaus Hermansen, MSc., Senior Specialist, Management Consulting, NNE Pharmaplan, Denmark
Everybody agrees that Vaccines and Vaccination programs can save many children's lives, especially in the emerging countries. For that reason, it is important to develop and manufacture high quality vaccines at an affordable cost. The concept of using modular and standardised "state of art" manufacturing facilities - developed by NNE Pharmaplan - makes it possible to set up such facilities much faster and to a lower cost. Combining this design concept by a turn key project strategy will make it possible for emerging countries to set up their own vaccine production at a very attractive cost.
Klaus Hermansen, MSc., Senior Specialist, Management Consulting, NNE Pharmaplan, Denmark
5:15
Networking Cocktail Reception with Exhibits & Poster Viewing
Main Conference: Monday | Tuesday | Wednesday | Workshops: Wednesday
Concurrent Tracks
Track I:Upstream & Downstream ProcessingCell Line Engineering & Development
8:50
Chairperson's Opening Remarks
Lin Zhang, Ph.D., Associate Research Fellow, Global Biologics, Worldwide Pharmaceutical Sciences, Pfizer Inc., USA
9:00
Protein Production via Stable Gene Expression using CHO Expression Platform
Abstract not available at time of print.. Lin Zhang, Ph.D., Associate Research Fellow, Global Biologics, Worldwide Pharmaceutical Sciences, Pfizer Inc., USA
9:30
Next Generation of CHO-DHFR Selection System to Rapidly Create High-Producing Stable Cell Line without MTX Amplification
In order to rapidly produce the therapeutic antibodies, we have developed a novel CHO-DG44 platform to quickly create stable cell lines without any MTX amplification. Using the next generation CHO-DG44 expression system, we were able to create the high-producing herceptin (anti-Her2 receptor humanized antibody) cell lines, which produce over 25pg/cell/day within 3 months. Importantly, the MTX-free cell lines stably produce the high level of herceptin over 3 months. Xiaoyun Wu, Ph.D., Chief Executive Officer, ADV Biosciences, LLC., USA
10:00
Development of Therapeutic Anti-B cell Antibodies
Using SinoMab's proprietary Framework-reengineering technology, we have developed different B-cell specific antibodies that target lymphoma and a variety of autoimmune diseases. These antibodies are in different stages of preclinical (IND application) and clinical (Phase I and Phase II) development. To meet the present and future demands for these antibodies, especially when after marketing approval, SinoMab has been gearing up its efforts through a combination of cell line selection, as well as bioreactor and process development, and has successfully built the required in-house capability for the production of clinical grade materials at typical pharmaceutical margins. Shawn Leung, Ph.D., Chief Executive Officer, SinoMab BioScience Limited, China
10:30
Networking Refreshment Break with Exhibits & Poster Viewing
Cell Culture & Media Development
11:00
Chairperson's Opening Remarks
Rajesh Krishnan, Ph.D., Senior Principal Scientist, Cell Culture and Fermentation Development, Merck & Co., Inc., USA
11:05
Strategy for Upstream Process Ranging to Map the Design Space for a Phase III Monoclonal Antibody Production Process
Abstract not available at time of print. Rajesh Krishnan, Ph.D., Senior Principal Scientist, Cell Culture and Fermentation Development, Merck & Co., Inc., USA
11:30
Defining Hydrolysates and Designing Quality
In this presentation, we will show how the CPQAs (Critical Product Quality Attributes) of protein hydrolysates can be defined at the level of individual components and how the CPPs (Critical Process Parameters) are assessed and the corresponding DS (Design Space) determined. Jan-Willem Boots, Ph.D., MSc., Innovation Manager, Life Sciences & Cell Nutrition, Ingredients Innovation, FrieslandCampina DOMO, The Netherlands
11:55
High Productivity Cell Culture Platform for Commercial Manufacturing
The fed-batch platform utilizes serum-free cell culture media and feeds, and disposable primary recovery technology. It has been tested for several products in lab-scale bioreactors and production scale disposable and stainless steel bioreactor in GMP environment. The platform performed well in high volumetric productivity. Jian Dong, Vice President, Manufacturing, Shanghai Kanda Biotechnology Co, Ltd., China |
Track II:Analytical Development, Product & Process CharacterizationAnalytical Methods Development
8:50
Chairperson's Opening Remarks
Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion, Inc., South Korea
9:00
Analytical Challenges in Follow-on Biologics Development
The market for follow-on biologics is expected to grow rapidly. However, therapeutic proteins are complex macromolecules. Small changes in post-translational modification, purity, or formulation could make real, meaningful differences in efficacy and safety. This talk will give an overview of the analytical challenges in follow-on biologics development and approaches industries take to address these challenges Sha Ha, Research Fellow, Bioprocess Analytical & Formulation Sciences, Merck & Co., Inc., USA
9:30
iCIEF and CE-SDS: From Process Development to Quality Control
New analytical technologies including electrophoretic based microseparation techniques have emerged to complement traditional methods, providing additional analytical abilities. Imaged capillary isoelectric focusing (iCIEF) has demonstrated great potential in the separation of charge variants, offering unique applications in defining molecular isoforms. Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) method has provided sensitive purity and impurity assay for proteins. Advances in both methodologies have resulted in advantages over traditional gel and approaches such as rapid analysis, versatile detection, automation capabilities, and increased resolving power. This presentation will demonstrate the utility of the technologies in process development, product characterization and GMP testing. Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion, Inc., South Korea
10:00
Analytical Strategies for the Development and Evaluation of Follow-on Biologics (Biosimilars)
We introduce our practice in Genor Biopharma Co. Ltd. by carefully selecting a panel of state-of-the-art analytical techniques for FOB characterization. The techniques were chosen case-by-case based on the different levels of complexity of the product, while aiming thorough characterization. The data provide a better informed and more robust understanding of what is under consideration when industry and the Agency discuss FOBs, which then enable quicker, more predictable and less costly development and regulatory decision-making, and finally allow industry to avoid unnecessary or unethical duplication of trials. George Wang, Ph.D., Senior Director, Analytical Sciences, Formulation & Quality, Genor Biopharma Co. Ltd., China
10:30
Networking Refreshment Break with Exhibits & Poster Viewing
Comparability and Product Characterization
11:00
Chairperson's Opening Remarks
Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion, Inc., South Korea
11:10
Developing and Utilizing Sub-visible Particulate Matter Measurement to Aid in Development of Biologics
There has been heightened interest in measuring sub-visible particulate matter in the 1-10 µm size range due to its potential correlation with aggregation and immunogencicity. This presentation will highlight methodologies and strategies available to characterize biopharmaceuticals with examples drawn from recent case studies. Thomas M. Spitznagel, Ph.D., Vice President, BioPharmaceutical Development, Human Genome Sciences, Inc., USA
11:40
Structural Comparability for Complex Molecules
Abstract not available at time of print. Hardy Chan, Ph.D., Chief Scientific Officer & Executive Vice President, ScinoPharm Taiwan Ltd., Taiwan |
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Concurrent Sponsored Presentations |
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12:20
Key Considerations When Screening Supplements for Medium Optimization
The contribution of protein hydrolysates to the performance of a biopharmaceutical production system is largely medium dependent. Improper application of hydrolysates during medium optimization may result in decreased system performance and/or increase system variability. Medium dependence will be discussed, along with a suggested hydrolysate screening protocol that will help ensure effective evaluation of a supplementation scheme's overall contribution to system performance.Jagdish Kuchibhatla, MSc., Director, Cell Nutrition, Business Development & Technical Sales, APAC, Sheffield Bio-Science |
12:20
Accelerating Cell Line and Media Development Workflows: Maximizing Success
By utilizing a combination of automation technologies and statistical DOE approaches we have streamlined and improved both cell line development and cell culture medium development workflows. Flow cytometry, ClonePix FL robotics, SimCell™ technology and liquid handling have been integrated into our workflows for real time measurement of cell proliferation and protein production. This talk will discuss how these combined technologies have improved the success rate in developing robust cell culture platforms for therapeutic protein production.Peggy Lio, Senior Process Science Fellow, Life Technologies Corporation, USA |
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12:45
Networking Luncheon with Exhibits & Poster Viewing
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Downstream Purification & Recovery
2:00
Chairperson's Opening Remarks
Christine Gebski, M.S., Director, POROS Applications and R&D, Life Technologies Corporation, USA
2:10
Modular Viral Clearance Validation for Monoclonal Antibodies Used in Clinical Trials
Both FDA and EMA guidelines allow the use of modular viral validation approach based on platform process and in house data. Genentech has developed many monoclonal antibody (mAb) products using similar purification processes, hence has extensive in house viral inactivation/removal data for several purification unit operations. Our data demonstrates that low pH, Triton X 100, virus filtration and anion exchange chromatography unit operations are robust viral inactivation/removal steps. Application of prior in-house data of these unit operations to new products in clinical development will be discussed. Qi Chen, Ph.D., Associate Director, Process Virology, Department of Late Stage Purification, Process Research and Development, Genentech, USA
2:40
Purification of Therapeutics from the Side Fractions of Plasma Fractionation
During cold ethanol fractionation of human plasma, many proteins of therapeutic value remain in side fractions. One of such, protein C, can be purified from the fraction IV by a combination of anionic exchange chromatography and other processing technologies, which may be further developed for pathological conditions with a severe deficiency of the protein. Vincent Xie, Ph.D., R&D Director, China Biologic Products, Inc., China
3:10
Sponsored by
Manufacturing Solutions with Potential to Unlock Existing Facilities' Future Production Two engineering solutions delete hold time and tanks, reduce costs 50% and boost productivity without the need for alternative technology: continuous capture chromatography (CCC) and straight-through processing (STP) are involving PAT-like dynamic control solutions to enable seamless processing between the bioreactor and final filtration of bulk drug substance. Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, BioTechnologies R&D, GE Healthcare Life Sciences, Sweden
3:40
Networking Refreshment Break with Exhibits & Poster Viewing
4:10
Sponsored by
Monoclonal Antibody Purification: Strategies for SuccessMonoclonal antibodies are typically purified using three chromatography steps, recombinant protein A affinity, cation exchange and anion exchange. The success of the chromatography resin used for each unit operation relies on specific attributes. Data from process productivity modeling will be used to reveal strategies for successful purification development. Christine Gebski, M.S., Director, POROS Applications and R&D, Life Technologies Corporation, USA
4:40
Panel DiscussionTurning Conflict and Overlaps Between Up- and Downstream into Communication and Integration - What Upstream and Downstream Process Scientists Should Know about Each Other
Frank Ho, Ph.D., Senior Manager, Clinical Manufacturing, BioMarin Pharmaceuticals, USA Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals, China
5:15
Close of Day Two
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Process Characterization, Validation & Quality Control
2:00
Chairperson's Opening Remarks
Daotian Fu, Ph.D., Vice President, Bioanalytical Development, Genzyme Corporation, USA
2:10
Process Characterization - The Only Sure Way Leading to Robust Process Development
Therapeutic proteins are complex in nature due to extensive post translational modifications and diverse high order structures. However these product attributes can be defined and often controlled by process characterization and robust manufacturing process. In this presentation, we will discuss current analytical approaches and how to effectively use them to support product characterization and various stages of process development. Daotian Fu, Ph.D., Vice President, Bioanalytical Development, Genzyme Corporation, USA
2:40
Product Variant Characterization and Determination of Critical Quality Attributes
Recombinantly produced monoclonal antibody products often contain size and charge variants and process changes often change the levels of these variants. This talk will present how to use different analytical methods to isolate and characterize these variants to ensure the drug is safe to use. Connie Xiuzhen Lu, Ph.D., Scientist, Protein Analytical Chemistry, Genentech, Inc., USA
3:10
Change Protocols and Process Validation
Process change is very critical to any process, especially when it is for biologics where the impact can be critical, subtle and difficult to evaluate its total impact. Process validation is the tool to prove robust process. Each change therefore must be approved through a change control committee comprising of subject matter experts who must evaluate it on risk-based and design space approaches. Such approaches are often difficult for products already on the market which were developed without the knowledge of design space. To affect changes in such process is difficult and risky. This presentation includes case studies describing how process changes were affected in the manufacture of biosimilars and process validation. Shaligram Rane, MSc., M.Ed., Head, QA, Intas Biopharmaceuticals, India
3:40
Networking Refreshment Break with Exhibits & Poster Viewing
4:10
Proteomic Approach for Host Cell Protein Identification and Evaluation to Support Process Development
Host Cell Proteins in Biologics are process-related impurities. During the development of Biologics, it is important to evaluate the levels and species of HCPs for potential risk assessment and process validation. Traditional approaches for HCP evaluation include Western Blot, ELISA and Gel Electrophoresis, each method provides valuable information on HCPs but also has its deficiencies. This presentation will give an overview of the current HCP analysis technology, and propose a comprehensive and systematic approach for HCP detection and evaluation. Xing Wang, Ph.D., Associate Research Fellow / Group Leader, Pfizer, Inc., USA
4:40
Practical Challenges in Successful Implementation of QBD
Solutions for deriving meaningful results adoption of QbD is transforming biopharmaceuticals globally. However, while QbD implementation, many users are confronted with various hurdles and often end up with unrealistic results which leads to question of approach suitability. Appropriate statistical tools, prior process knowledge utilization, thorough experimental design and result analysis can assure accurate predictability without being resource intensive. The presentation attempts to address approaches to solve these challenges during QbD implementation. Mayank Garg, M.Tech., Manager, Bio Bulk Maufacturing, Intas Biopharmaceuticals Ltd., India
5:10
Close of Day Two
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Main Conference: Monday | Tuesday | Wednesday | Workshops: Wednesday
Disposables
Session Sponsor:
8:15
Chairperson's Opening Remarks
Joe Zhou, Ph.D., Chief Executive Officer, Genor Biopharma, Wison Group, China
Joe Zhou, Ph.D., Chief Executive Officer, Genor Biopharma, Wison Group, China
8:25
Sponsored by
Rapid Facility Engineering: Are Disposable Capacities a Constraintto Meet Global Demand?The current biotech industry is evaluating the Rapid Facility Engineering options and caught between the traditional approach (SS vessels, miles of piping and validation complications) and the modern approach of using single-use technologies and the capacities available. In the past, to meet global demand molecules with expression levels of 1 -2 g/L needed to be manufactured in larger capacities of 10,000L or more. In the present scenario, looking at the trends where the expression levels have reached around 5 - 10 g/L. smaller and more compact facilities up to 2,000L capacity are in demand. In this environment should capacity to build a disposable facility be a limitation? Understand the financial implications of excess capacities in traditional plant compared to single-use engineering concepts of which have distinct advantages over the traditional plant infrastructure.
Surendra Balekai, Technical Services Manager, Thermo Fisher Scientific, India
8:55
Accelerating Process Development for Clinical Manufacturing of Monoclonal Antibodies using Single Use Bioreactors
Agensys utilized the CellREady 3-L disposable bioreactor for bench-scale development, and used the Sartorius 50-L and 250-L Single Use Bioreactor for process scale-up. Data from experiments that were performed in 3-L disposable bioreactors and in the conventional 5-L glass vessels to assess comparability in cell culture performance will be presented. In addition, data from 50-L and 250-L will be presented to illustrate scalability of using 3-L disposable bioreactors.
Marie Zhu, Ph.D., Associate Director, Process Development, Agensys Inc., USA
Agensys utilized the CellREady 3-L disposable bioreactor for bench-scale development, and used the Sartorius 50-L and 250-L Single Use Bioreactor for process scale-up. Data from experiments that were performed in 3-L disposable bioreactors and in the conventional 5-L glass vessels to assess comparability in cell culture performance will be presented. In addition, data from 50-L and 250-L will be presented to illustrate scalability of using 3-L disposable bioreactors.
Marie Zhu, Ph.D., Associate Director, Process Development, Agensys Inc., USA
9:20
Economic Analysis for Application of Disposables in Bioprocessings
Disposables are widely used in both upstream and downstream processes because of its flexibility and efficiency. However, it is always debatable whether disposable solutions impose more cost or saving because it depends on the process, cycle, etc. In addition, it is different situation in different parts of the world. A model was established for the economic analysis of disposable solutions to facilitate decision-making in bioprocessing.
Jason Li, Ph.D., Director, Purification, Genor Biopharma, China
Disposables are widely used in both upstream and downstream processes because of its flexibility and efficiency. However, it is always debatable whether disposable solutions impose more cost or saving because it depends on the process, cycle, etc. In addition, it is different situation in different parts of the world. A model was established for the economic analysis of disposable solutions to facilitate decision-making in bioprocessing.
Jason Li, Ph.D., Director, Purification, Genor Biopharma, China
9:45
Sponsored Presentation Available
IBC's sponsored presentations offer suppliers and service companies the opportunity to present their exciting technologies in bioprocessing to a targeted and captive audience during the conference sessions. For more information on this unique opportunity, please contact Sherry Johnson at sjohnson@ibcusa.com (US/EU) or Janice Tan at Janice.tan@ibcasia.com.sg (Asia Pacific).
IBC's sponsored presentations offer suppliers and service companies the opportunity to present their exciting technologies in bioprocessing to a targeted and captive audience during the conference sessions. For more information on this unique opportunity, please contact Sherry Johnson at sjohnson@ibcusa.com (US/EU) or Janice Tan at Janice.tan@ibcasia.com.sg (Asia Pacific).
10:10
Networking Refreshment Break
Protein Stability & Formulation
11:00
Chairperson's Opening Remarks
Wei Wang, Ph.D., Research Fellow, BioTherapeutics R&D, Pfizer Inc., USA
Wei Wang, Ph.D., Research Fellow, BioTherapeutics R&D, Pfizer Inc., USA
11:05
Integrated Approach and Design Space Considerations in Formulation and Drug Product Development for Parenteral Protein Therapeutics
An integrated approach on formulation and drug product development is prudent to ensure successful development of a robust and competitive product. Good understanding of the chemical and physical factors pertaining to interactions between formulation, container closure, and manufacturing process that will affect stability and quality of the product is importance. Design space considerations from simple to complex drug product presentation will be discussed in this presentation.
Ping Yeh, Ph.D., Director, Protein Pharmaceutical Development, Biogen Idec, USA
An integrated approach on formulation and drug product development is prudent to ensure successful development of a robust and competitive product. Good understanding of the chemical and physical factors pertaining to interactions between formulation, container closure, and manufacturing process that will affect stability and quality of the product is importance. Design space considerations from simple to complex drug product presentation will be discussed in this presentation.
Ping Yeh, Ph.D., Director, Protein Pharmaceutical Development, Biogen Idec, USA
11:30
Protein Oxidation and Formulation Strategy
Oxidation has been a challenge for protein formulation development. The conventional approach of using hydrogen peroxide generated predominantly methionine oxidation, but missed tryptophan oxidation which has recently emerged as one of the major instability concerns. The mechanisms, stress models and formulation strategy of protein oxidation will be discussed in this talk.
Andrea J. Ji, Ph.D., Scientist, Genentech, Inc., USA
John Y. Wang, Ph.D., Principal Scientist, Late Stage Pharmaceutical & Processing Department, Genentech, Inc., USA
Oxidation has been a challenge for protein formulation development. The conventional approach of using hydrogen peroxide generated predominantly methionine oxidation, but missed tryptophan oxidation which has recently emerged as one of the major instability concerns. The mechanisms, stress models and formulation strategy of protein oxidation will be discussed in this talk.
Andrea J. Ji, Ph.D., Scientist, Genentech, Inc., USA
John Y. Wang, Ph.D., Principal Scientist, Late Stage Pharmaceutical & Processing Department, Genentech, Inc., USA
11:55
Molecular Mechanism of Monoclonal Antibody Aggregation and Its Implication for Formulation Development
In this presentation, we shall discuss the molecular mechanism underlying monoclonal antibody aggregation commonly observed during formulation development. The effect of various stresses including heat exposure and shear force on the formation of monoclonal antibody aggregates shall be discussed. Structures of different types of monoclonal antibody aggregates have been characterized by using FTIR spectroscopy. The role of different antibody domains (Fc and Fab) in aggregation has been investigated, to illustrate the mechanism of soluble and insoluble aggregates formed under different types of stresses. Finally, the formulation strategy to minimize the formation of monoclonal antibody aggregates shall be discussed.
Tiansheng Li, Ph.D., President, HTL Biosolutions Inc., USA
In this presentation, we shall discuss the molecular mechanism underlying monoclonal antibody aggregation commonly observed during formulation development. The effect of various stresses including heat exposure and shear force on the formation of monoclonal antibody aggregates shall be discussed. Structures of different types of monoclonal antibody aggregates have been characterized by using FTIR spectroscopy. The role of different antibody domains (Fc and Fab) in aggregation has been investigated, to illustrate the mechanism of soluble and insoluble aggregates formed under different types of stresses. Finally, the formulation strategy to minimize the formation of monoclonal antibody aggregates shall be discussed.
Tiansheng Li, Ph.D., President, HTL Biosolutions Inc., USA
12:20
Effect of Glycosylation on Protein Stability/Formulation
Glycosylation state can potentially affect the biochemical, physiological, and pharmacological properties of proteins, such as solubility, stability, activity, intracellular trafficking, pharmacokinetics, and immunogenicity. Among these properties, solubility and stability are two key parameters for consideration and evaluation in the development of a protein drug product. This presentation compares the pH-dependent thermal and storage stabilities of model glycosylated and non-glycosylated proteins. Formulation implications and strategies are discussed for the successful development of such a drug product.
Wei Wang, Ph.D., Research Fellow, BioTherapeutics R&D, Pfizer Inc., USA
Glycosylation state can potentially affect the biochemical, physiological, and pharmacological properties of proteins, such as solubility, stability, activity, intracellular trafficking, pharmacokinetics, and immunogenicity. Among these properties, solubility and stability are two key parameters for consideration and evaluation in the development of a protein drug product. This presentation compares the pH-dependent thermal and storage stabilities of model glycosylated and non-glycosylated proteins. Formulation implications and strategies are discussed for the successful development of such a drug product.
Wei Wang, Ph.D., Research Fellow, BioTherapeutics R&D, Pfizer Inc., USA
12:45
Close of Conference
I: International Regulatory Standards: Meeting GMP Expectations for Facility Design and Operation2:00 pm - 5:30pm Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc., USA The purpose of this workshop is to highlight international regulatory standards for design, construction, validation, and operation of a biopharmaceutical facility for therapeutics, vaccines and devices, including quality systems and manufacturing operations. Those who attend will gain a deeper understanding of:
This workshop is designed for those with responsibility in:
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II: Using Label-free Biophysical Methods for Characterization and Immunogenicity Testing of Biological Products2:00 pm - 5:30pm
Fredrik Sundberg, Global Director, GE Healthcare, Sweden Rapid and precise analytical technologies for characterization of biological products are critical for successful drug development and GMP-manufacturing. Label-free biophysical technologies are an interesting complement, or alternative, over traditional methods and have considerable benefits in terms of providing improved productivity in process development and more in-depth understanding of bio-molecular interactions. The objective with this workshop is to show how information-rich label-free assays, such as SPR (Surface Plasmon Resonance) biosensors and ultra-sensitive calorimetry can be implemented throughout the workflow. Practical case-studies around key applications for monoclonal antibodies, recombinant protein therapeutics and vaccines will be presented. Regulatory considerations, assay development and validation approaches will also be covered. Those who attend will gain a deeper understanding of:
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