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Mark Your Calendar for 2012
October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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Cell Culture
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:30
Networking Coffee
12:30
Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Poster presenters are requested to stand by their posters for discussion.
Cell Culture
1:45
Chairperson's Remarks
Chun Zhang, Ph.D., Senior Director, Cell Culture Process Development, Shire Pharmaceuticals
Chun Zhang, Ph.D., Senior Director, Cell Culture Process Development, Shire Pharmaceuticals
Disposables in Cell Culture
Unpublished Data
2:00
Toward the Goal of a 100% Disposable Cell Culture Manufacturing Process
In a stepwise process, single-use bioreactors, medium storage bags, sampling assemblies and other disposables are eliminating the need for glass and steel. However, a number of bottlenecks remain before the autoclave can be put to rest and a 100% disposable process can be achieved. This presentation will review the migration of single-use disposables into a pilot scale cell culture manufacturing facility for early clinical trials.
Charles Sardonini, Ph.D., Associate Director, Cell Culture Development Group, Genzyme Corp.
In a stepwise process, single-use bioreactors, medium storage bags, sampling assemblies and other disposables are eliminating the need for glass and steel. However, a number of bottlenecks remain before the autoclave can be put to rest and a 100% disposable process can be achieved. This presentation will review the migration of single-use disposables into a pilot scale cell culture manufacturing facility for early clinical trials.
Charles Sardonini, Ph.D., Associate Director, Cell Culture Development Group, Genzyme Corp.
Unpublished Data
2:30
Case
Study
Recent Experiences with Single-Use Containers used for Cell Culture Media ApplicationsStudy
Disposables are used for liquid media storage, handling media prior to cell culture inoculation, and for cell culture operations. We investigated disposables for our cell culture processes to better understand and prevent negative impact on cell growth and product yields correlated with specific disposables and the conditions of their use. We will review the challenges, knowledge gained and lessons learned.
Masaru Shiratori, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc.
Unpublished Data
3:00
Case
Study
Challenges Encountered by Implementing Disposable BioreactorsStudy
Establishing disposable technology in mammalian cell culture upstream processes enables fast and flexible development and production of biopharmaceuticals. However unexpected challenges can emerge even when using already common and standardized disposable technology. The use of these learning's lead to a risk based approach. Examples will be presented and learning's towards a risk based approach for evaluation and characterization of new disposable technology prior use in production processes will be discussed.
Joachim Bär, Ph.D., Associate Director Manufacturing Science Upstream, Biopharmaceutical Operations Germany, Manufacturing Science and Technology, Boehringer Ingelheim GmbH & Co Kg., Germany
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Keynote Presentations
4:15
Bioprocess Technology & Innovation: Strategic Imperative for Challenging TimesCan bioprocess innovation continue to be an important strategic advantage and generate value? What drivers should inform a meaningful technology and innovation strategy, and what approaches and infrastructure are needed to support it? The changing landscape has brought many new challenges, including vastly decentralized research and idea creation, virtual companies, novel treatment modalities, an expansion of viable production technologies, biosimilars, regionalization and globalization, and a complex regulatory and intellectual property environment. From the perspective of a large global biopharma company, developing and implementing an aggressive, multifaceted strategy is essential; examples and perspective on the journey will be provided.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
5:00
Integrating Two Biologics Manufacturing NetworksThe Roche Group acquired Genentech in March 2009, resulting in the integration of two distinct biologics manufacturing networks. The challenge of integrating these two organizations required addressing people, process and technologies across the entire supply chain from raw material sourcing through delivery to patients. The manufacturing operations of these two companies recognized that that integration takes as much focus on decision-making governance and company culture as it does on physical assets, operations and organization.
Tim Moore, Senior Vice President, Global Head, Pharmaceutical Technical Operations Biologics, Roche
5:45
Networking Reception in Poster and Exhibit Hall
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Cell Culture
8:00
Chairperson's Remarks
Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development, Global Biological Development, Bayer HealthCare
Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development, Global Biological Development, Bayer HealthCare
Systems Biology Approaches to Cell Culture Development
Keynote Presentation
Unpublished Data
8:05
The International Chinese Hamster Ovary Genome Project: Where Do We Go from Here?A new era is about to begin in biotechnology community. Today, a quarter of all FDA approved new drugs are biopharmaceuticals, most of which are produced in Chinese hamster ovary (CHO) cells. Sequencing and characterizing CHO K1 and other related cell lines and tissues is being pursued in earnest by a variety of international groups. The impact that these events will have on biotechnology and bioprocessing is not yet clear. But it is likely that the sequencing of the CHO genome will transform the way in which cells and processes are analyzed and improved in future decades. This presentation will discuss ongoing efforts to characterize the genome, proteome, and other omics sources in the CHO community. How these changes may transform the way biotechnology problems are solved will also be discussed including representative examples from our laboratories and others. Reaping the greatest benefits of this information explosion will require the community to coordinate efforts in new and different ways. As a result, we will discuss ongoing efforts to organize, distribute, and share the rapidly expanding CHO genomics knowledge base in a framework that will provide users with the tools that will provide the greatest benefit to the entire biotechnology community.
Michael Betenbaugh, Ph.D., Professor, Chemical and Biomolecular Engineering, Johns Hopkins University
Unpublished Data
8:45
A Genome-Scale Metabolic Model of CHO Cell Line
Using an integrated computational and experimental platform, we have developed genome-scale metabolic models for CHO and NS0 cell lines. The reconstructed model of CHO was used to develop proprietary media and novel selectable markers. Experimental implementation of the modeling strategies showed improvement in metabolic characteristics of the cell culture. The approach has the potential to also improve product quality and glycosylation.
Iman Famili, Ph.D., Senior Director, Research and Development, GT Life Sciences, Inc.
Using an integrated computational and experimental platform, we have developed genome-scale metabolic models for CHO and NS0 cell lines. The reconstructed model of CHO was used to develop proprietary media and novel selectable markers. Experimental implementation of the modeling strategies showed improvement in metabolic characteristics of the cell culture. The approach has the potential to also improve product quality and glycosylation.
Iman Famili, Ph.D., Senior Director, Research and Development, GT Life Sciences, Inc.
Unpublished Data
9:15
Predicting Cell Specific Productivity from CHO Gene Expression
We present the first predictive model of productivity in CHO bioprocess culture based on gene expression profiles. A supervised regression algorithm, partial least squares (PLS) incorporating jackknife gene selection, was utilised to produce a model of cell-specific productivity (Qp) capable of predicting Qp to within 4.44 pg/cell/day. Several of the genes constituting the model are linked with biological processes relevant to protein metabolism.
Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology, Dublin City University, Ireland
We present the first predictive model of productivity in CHO bioprocess culture based on gene expression profiles. A supervised regression algorithm, partial least squares (PLS) incorporating jackknife gene selection, was utilised to produce a model of cell-specific productivity (Qp) capable of predicting Qp to within 4.44 pg/cell/day. Several of the genes constituting the model are linked with biological processes relevant to protein metabolism.
Colin Clarke, Ph.D., Postdoc, National Institute for Cellular Biotechnology, Dublin City University, Ireland
9:45
Networking Refreshment Break in Exhibit and Poster Hall
Novel Approaches to Cell Line Development
Unpublished Data
10:30
Applying Integrated Technology Strategies to Streamline Workflow in Cell Line Development
Lin Zhang, Ph.D., Associate Research Fellow, Pfizer Inc.
Lin Zhang, Ph.D., Associate Research Fellow, Pfizer Inc.
Unpublished Data
11:00
How Does Genetic Heterogeneity in CHO Cell Populations Effect Cell Line Development?
David C. James, Ph.D., Professor of Bioprocess Engineering, Department of Chemical and Process Engineering, University of Sheffield, United Kingdom
David C. James, Ph.D., Professor of Bioprocess Engineering, Department of Chemical and Process Engineering, University of Sheffield, United Kingdom
11:30
Use of Multiwell Plates and Islands of Automation for Cell Line Constructions
Lonza has incorporated the use of shaking 96 well plates into fed-batch culture evaluations. The presentation will review some of the technologies available for scaled down fed-batch culture. Recently Lonza has expanded the use of deep well cell culture to use "islands" of automation to enable the maintenance of cell cultures at small volumes and has integrated this technology into its One-Step cell line constructions.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
Lonza has incorporated the use of shaking 96 well plates into fed-batch culture evaluations. The presentation will review some of the technologies available for scaled down fed-batch culture. Recently Lonza has expanded the use of deep well cell culture to use "islands" of automation to enable the maintenance of cell cultures at small volumes and has integrated this technology into its One-Step cell line constructions.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics plc, United Kingdom
12:30
Networking Luncheon & Last Chance to Visit the Exhibit and Poster Hall
Cell Culture
1:40
Chairperson's Remarks
Inn Yuk, Ph.D., Senior Group Leader, Genentech, Inc.
Inn Yuk, Ph.D., Senior Group Leader, Genentech, Inc.
Advances in Media and Feed Design
Sponsored by
Unpublished Data
1:45
Case
Study
Optimizing Large-Scale Implementation of High Yield Chemically-Defined Media for Improving Cell Culture Scale-Up Performance and Product Quality, and Ensuring Commercial Facility-FitStudy
A high-yield chemically-defined medium for cell culture was successfully developed for commercial manufacturing use. Manufacturing operation in the preparation and treatment of the chemically-defined media can have a profound impact on cell culture performance hence the scale-up from bench scale to commercial scale. Understanding the impact of these operations such as filtration, high temperature short time (HTST) treatment, hold stability and storage on the media is critical, and need to be taken into consideration during transfer and scale-up. Strategies to mitigate the risk of these operations for optimizing large-scale cell culture performance were developed and implemented for facility-fit.
Henry Lin, Ph.D., Senior Scientist, Cell Science & Technology, Amgen Inc.
2:15
Navigating the Biopharmaceutical Regulatory Pathway: Replacing Undefined Raw Materials with Chemically-Defined Substitutes in Approved Product Upstream Processing
The decision to make a raw material or manufacturing process change for a marketed biopharmaceutical product can involve consideration of a large number of variables, and is not one to be taken lightly. One key aspect of this relates to the regulatory requirements that would need to be addressed concerning the proposed change. Regulatory pressures to remove animal products continue to rise, as the risk of known or unknown viral or TSE contaminants can outweigh the benefits of using these products. Additionally, the replacement of undefined raw materials can improve process consistency and reduce total biological drug manufacturing costs. To these points, this discussion will focus on consideration of removing undefined raw materials used to produce marketed drugs and replacing these raw materials with chemically-defined substitutes. The focus will be on what regulatory concerns are raised when contemplating such a change, various approaches that may be considered when faced with these regulatory issues, and how your supplier(s) can assist in successful resolution of this challenging process.
James Carver, Quality Manager, Quality Assurance, BD Biosciences - Discovery Labware
The decision to make a raw material or manufacturing process change for a marketed biopharmaceutical product can involve consideration of a large number of variables, and is not one to be taken lightly. One key aspect of this relates to the regulatory requirements that would need to be addressed concerning the proposed change. Regulatory pressures to remove animal products continue to rise, as the risk of known or unknown viral or TSE contaminants can outweigh the benefits of using these products. Additionally, the replacement of undefined raw materials can improve process consistency and reduce total biological drug manufacturing costs. To these points, this discussion will focus on consideration of removing undefined raw materials used to produce marketed drugs and replacing these raw materials with chemically-defined substitutes. The focus will be on what regulatory concerns are raised when contemplating such a change, various approaches that may be considered when faced with these regulatory issues, and how your supplier(s) can assist in successful resolution of this challenging process.
James Carver, Quality Manager, Quality Assurance, BD Biosciences - Discovery Labware
2:30
Rapid Development of Chemically Defined Medium Through Replacement of Basal Hydrolysates
Protein hydrolysates are widely used in mammalian cell culture to improve cell growth and recombinant protein production. However, use of the hydrolysates can lead to significant process variability, due to the limited control of their source and final composition during manufacturing. On the other hand, development of a chemically defined medium requires a tremendous amount of work, including comprehensive library screening and spent media analysis. In this study, we describe a rapid method for developing a chemically defined medium for Chinese hamster ovary (CHO) cell lines from an existing proprietary medium by the replacement of basal protein hydrolysates with novel supplements. After two rounds of optimization, the protein hydrolysate was successfully replaced. Cell growth, protein productivity, and product quality were similar in the chemically defined and original medium. The entire development process was completed within six weeks.
Hao Chen, Ph.D., Senior Scientist, BioProcess Development, Merck & Co., Inc.
Protein hydrolysates are widely used in mammalian cell culture to improve cell growth and recombinant protein production. However, use of the hydrolysates can lead to significant process variability, due to the limited control of their source and final composition during manufacturing. On the other hand, development of a chemically defined medium requires a tremendous amount of work, including comprehensive library screening and spent media analysis. In this study, we describe a rapid method for developing a chemically defined medium for Chinese hamster ovary (CHO) cell lines from an existing proprietary medium by the replacement of basal protein hydrolysates with novel supplements. After two rounds of optimization, the protein hydrolysate was successfully replaced. Cell growth, protein productivity, and product quality were similar in the chemically defined and original medium. The entire development process was completed within six weeks.
Hao Chen, Ph.D., Senior Scientist, BioProcess Development, Merck & Co., Inc.
Unpublished Data
2:45
Case
Study
Variability of Media Components - Impact on Product QualityStudy
This case study will review recent technology transfer challenges that were encountered for a monoclonal antibody produced in CHO cell culture due to variable trace element (TE) content of cell culture media. Initial experiments focused on the understanding and controlling the impact of TE variability on product quality differences between Amgen and a contract manufacturer. Subsequently, the cell culture metabolism of the process was shown to be sensitive to levels of a particular TE that required additional controls to be put in place.
Christopher Crowell, Ph.D., Principal Scientist, Process Development, Amgen Inc.
3:15
Networking Refreshment Break
Plenary Session: Innovative Principles and Integration in Upstream and Downstream Processing
Unpublished Data
3:45
Case
Study
Integrating Downstream Requirements in Upstream Processing - Optimizing Mass Throughput and Insuring Product QualityStudy
Bruno Figueroa Jr., Ph.D., Senior Principal Scientist, BioTx Pharm Sciences, Bioprocess R&D, Pfizer Inc.
4:15
Case
Study
Design of a Facility of the Future for Integrated Upstream and Downstream Processing for Fed-Batch and Perfusion ManufacturingStudy
Production Technology and Cell Biology is developing rather quickly while current Biotech Facilities once constructed and in operation are rather difficult to change. The presentation will try to address the changes seen in Biotech production and will evaluate how modern facility concepts maybe able to address ongoing and future changes.
Thomas Daszkowski, Ph.D., Vice President, Head of Process Technology BTS-A, Bayer Technology Services
Keynote Presentation
4:45
The Impact of Antibody Drug Conjugates on Process Development and ManufacturingThe antibody-drug conjugate (ADC) concept is to use an antibody to deliver a cytotoxic drug selectively to a target such as a tumor-associated antigen. Such conjugates represent a broadly applicable approach to enhance the antitumor activity of antibodies and improve the tumor-to-normal tissue selectivity of chemotherapy. There is a rapidly growing number of ADC's moving through clinical development towards the marketplace. This talk will review the ADC field and focus on some of the unique challenges and opportunities from a process development and manufacturing perspective.
Morris Rosenberg, Ph.D., Executive Vice President, Process Sciences, Seattle Genetics
5:30
Close of Day Three
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Cell Culture
8:00
Chairperson's Remarks
Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc.
Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc.
Accelerating and Optimizing Process Development and Production
8:15
Development and Implementation of Small Scale High-throughput Bioreactors and Implementation into Cell Line Selection and Process Development to Deliver the Biopharmaceutical Pipeline
Today's biopharmaceutical organizations must reduce timelines and manage ever-shrinking resources. Data will be presented showing the development of small scale bioreactors for both mammalian and microbial cell line selection and process optimization activities, demonstrating the advantages of controlled "high-throughput" bioreactors that allow rapid, very early stage process development which can contribute to shorter development timelines and; ultimately, lower development costs.
Tiffany D Rau, Ph.D., Global Technology/Technical Manager, Pall Corp.
Today's biopharmaceutical organizations must reduce timelines and manage ever-shrinking resources. Data will be presented showing the development of small scale bioreactors for both mammalian and microbial cell line selection and process optimization activities, demonstrating the advantages of controlled "high-throughput" bioreactors that allow rapid, very early stage process development which can contribute to shorter development timelines and; ultimately, lower development costs.
Tiffany D Rau, Ph.D., Global Technology/Technical Manager, Pall Corp.
Unpublished Data
8:45
Reducing Timelines and Effort - What are the Walls People are Hitting with Present Processes?
Lonza has incorporated the use of shaking 96 well plates into fed-batch culture evaluations. The presentation will review some of the technologies available for scaled down fed-batch culture. Recently Lonza has expanded the use of deep well cell culture to use "islands" of automation to enable the maintenance of cell cultures at small volumes and has integrated this technology into its One-Step cell line constructions.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics, United Kingdom
Lonza has incorporated the use of shaking 96 well plates into fed-batch culture evaluations. The presentation will review some of the technologies available for scaled down fed-batch culture. Recently Lonza has expanded the use of deep well cell culture to use "islands" of automation to enable the maintenance of cell cultures at small volumes and has integrated this technology into its One-Step cell line constructions.
Adrian Haines, Ph.D., Principal Scientist, Process Development Sciences, Lonza Biologics, United Kingdom
9:15
Case
Study
When Facility Flexibility Matters: A Case Study in Supporting New Technology Implementations Required for a Phase III ProcessStudy
Successful execution of a clinical campaign requires that a sufficient amount of drug of acceptable quality is produced, in time to supply the clinical trial. Witness aspects of facility flexibility that enabled a recent Phase III process transfer to successfully introduce a novel seed train strategy, chemically defined media formulations, and a modular viral clearance step within the project timelines.
Yael Hirsch, Engineer II, Manufacturing Science and Technology, Genentech, Inc.
9:45
Networking Refreshment Break
Beyond Antibodies - Cell Culture Process Development of Novel Molecules and Next Generation Therapeutics
Unpublished Data
10:15
Case
Study
Development and Regulatory Challenges of Autologous Activated Cellular Immunotherapies(ACIs)Study
Christopher G. Ramsborg, Ph.D., Senior Process Development Engineer, Cellular Immunotherapy Development, Dendreon Corporation
Unpublished Data
10:45
Case
Study
Development of a Manufacturing Platform for a Unique Next Generation Antibody, the κλ-BodyStudy
In certain diseases, targeting a single protein might not be sufficient to achieve efficacy and this has prompted the development of innovative antibody formats that are selectively cross-reactive. NovImmune has developed a novel therapeutic bispecific monoclonal antibody format, called "Kappa Lambda antibody". The talk will address the specific technical considerations taken by NovImmune to face the manufacturing challenges and constraints of this novel bispecific antibody format.
Nicolas Fouque, M.S., Section Head, Process Development and Bulk Manufacture, Bioprocessing, NovImmune
Unpublished Data
11:15
Challenges of Applying an Antibody Cell Culture Platform onto Process Development and Scale-up of Dual Variable Domain Immunoglobulins (DVD-Igs)
Antibody platform processes in hydrolysate-based or chemically defined media were challenged with a new class of bispecific molecules: dual variable domain immunoglobulins (DVD-Igs). Three unique DVD-Igs targeted for process development and scale-up had distinctive growth behaviors in our cell culture platforms. mRNA levels were analyzed to reveal possible mechanisms responsible for broad cell-specific productivity differences observed.
Alane Wentz, Ph.D., Process Development Senior Scientist, Process Sciences, Abbott Bioresearch Center
Antibody platform processes in hydrolysate-based or chemically defined media were challenged with a new class of bispecific molecules: dual variable domain immunoglobulins (DVD-Igs). Three unique DVD-Igs targeted for process development and scale-up had distinctive growth behaviors in our cell culture platforms. mRNA levels were analyzed to reveal possible mechanisms responsible for broad cell-specific productivity differences observed.
Alane Wentz, Ph.D., Process Development Senior Scientist, Process Sciences, Abbott Bioresearch Center
12:15
Lunch on Your Own
Cell Culture
1:25
Chairperson's Remarks
Kevin Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC
Kevin Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC
Improving Predictability in Early Development
Unpublished Data
1:30
Evaluation and Implementation of High-Throughput Bioreactor Systems in Cell Culture Process Development
As process development timelines have shrunk across the biotechnology industry and Quality-by-Design (QbD) initiatives are taking a more predominant role, there is an acute need to generate the necessary data quickly and efficiently, To better understand the balance between data quality and quantity, we have evaluated two High-Throughput Bioreactor systems (HTBS) for cell culture process development. While retaining the advantages of a shake flask-based system, including low manual labor and cost, these milliliter-scale bioreactors provide a pH and oxygen-controlled environment. This is critical for scalable prediction of product quality and volumetric productivity. Here, we have summarized the methodology and the factors considered for a comprehensive evaluation of the two HTBS [µ-24 (Pall/ Microreactor Technologies) and ambr™ 24 (TAP Biosystems)]. In particular, we have found that statistical analysis of data, specifically the power calculations, is an effective method for assessing variability and resolution inherent to the system. Results from such analysis as well as certain other factors play a critical role in determining which applications are best suited for that system. Finally, as a result of these evaluations, we have assigned an appropriate HTBS to each step in the cell culture process development cycle allowing an effective, synergistic use of these two HTBS.
Someet Narang, Ph.D., Scientist II, Cell Culture, MedImmune LLC
As process development timelines have shrunk across the biotechnology industry and Quality-by-Design (QbD) initiatives are taking a more predominant role, there is an acute need to generate the necessary data quickly and efficiently, To better understand the balance between data quality and quantity, we have evaluated two High-Throughput Bioreactor systems (HTBS) for cell culture process development. While retaining the advantages of a shake flask-based system, including low manual labor and cost, these milliliter-scale bioreactors provide a pH and oxygen-controlled environment. This is critical for scalable prediction of product quality and volumetric productivity. Here, we have summarized the methodology and the factors considered for a comprehensive evaluation of the two HTBS [µ-24 (Pall/ Microreactor Technologies) and ambr™ 24 (TAP Biosystems)]. In particular, we have found that statistical analysis of data, specifically the power calculations, is an effective method for assessing variability and resolution inherent to the system. Results from such analysis as well as certain other factors play a critical role in determining which applications are best suited for that system. Finally, as a result of these evaluations, we have assigned an appropriate HTBS to each step in the cell culture process development cycle allowing an effective, synergistic use of these two HTBS.
Someet Narang, Ph.D., Scientist II, Cell Culture, MedImmune LLC
Unpublished Data
2:00
Case
Study
Development of Predictive Methods for Cell Line Selection and Process DevelopmentStudy
Development of Predictive Methods for Cell Line Selection and Process Development Cell line selection programs and early stage process development are currently undergoing major changes. This presentation focuses on the development of a robust fed-batch platform process in a 96-deepwell plate system aimed to accurately predict bioreactor performance. We present the key features and benefits of the system and how it was implemented in upstream process development at Merck Serono.
Arnaud Perilleux, M.D., Scientist, Biotech Process Sciences, Upstream Processing, Merck Serono S.A., Switzerland
Unpublished Data
2:30
Clonal Analysis in Microfluidic Cell Culture Arrays
Advances in stem cell research have led to cells being tested as therapeutic agents in an array of clinical trials. Cell population heterogeneity poses a major obstacle to understanding complex biological processes. We have developed microfluidic devices containing thousands of nanoliter-scale bioreactors for the culture of single cells or colonies.
James Piret, Ph.D., Professor, Michael Smith Laboratories & Department of Chemical and Biological Engineering, University of British Columbia
Advances in stem cell research have led to cells being tested as therapeutic agents in an array of clinical trials. Cell population heterogeneity poses a major obstacle to understanding complex biological processes. We have developed microfluidic devices containing thousands of nanoliter-scale bioreactors for the culture of single cells or colonies.
James Piret, Ph.D., Professor, Michael Smith Laboratories & Department of Chemical and Biological Engineering, University of British Columbia
3:00
Networking Refreshment Break
Improving and Controlling Product Quality
Unpublished Data
3:30
Case
Study
Process Development, Clinical Production and Characterization of a Biosimilar mAbStudy
The approval pathway for complex biosimilar therapeutics, such as monoclonal antibodies, continues to be debated and the exercises to establish comparability between the biosimilar and innovator molecule at both the preclinical and clinical levels can be challenging. Therefore the design for the production process for a biosimilar must be carefully considered for its ability to produce a highly consistent, comparable product. This presentation will outline a case study illustrating the successful process development, characterization and scaled-up cGMP production of a biosimilar antibody that includes the creation of a well characterized small scale model for high-throughput process development and the analytical requirements for the development of a biosimilar mAb from clone selection to comparability of clinical drug product.
Sharyn Farnsworth, M.Sc., Fujifilm Diosynth Biotechnologies
Unpublished Data
4:00
Case
Study
Developing Tools to Prevent Product Sequence VariantsStudy
The occurrence of recombinant protein sequence variants (SV) is a challenging issue in CHO cell line development. A tyrosine to phenylalanine SV was detected at low levels in 28 sites within a recombinant product. This case study demonstrates how amino acid supplementaion was used to eliminate a low level sequence variant (< 2%) caused by tyrosine misincorporation.
Lauren Feeney, Research Associate, Late Stage Cell Culture, Pharma Technical Development, US Biologics, Genentech, Inc.
Unpublished Data
4:30
Case
Study
Process Change for Late Phase Project: Challenges and OpportunitiesStudy
Cell culture process change could change product quality attributes and even drug product stability. In a case study, we will demonstrate how we doubled titer and delivered comparability, manufacturability and scalability package of the new cell culture process to enable the cell culture process change in a late phase project.
Anli Ouyang, Ph.D., Senior Consultant Engineer, Bioproduct R&D, Eli Lilly and Company
5:00
Close of BPI 2011
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