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August 20-21, 2013
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Recovery & Purification Agenda
- 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.
Recovery & Purification
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:00
Registration and Coffee
8:00
Chairman's Opening Remarks
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
New Paradigm Continuous Processing in Biomanufacturing
Unpublished Data
8:15
Towards a Continuous Process: Impact of Flow-Through Chromatography on Process Design
An internal effort to streamline purification process development and reduce manufacturing complexity resulted in a semi-continuous antibody purification process. This process employs a single buffer species and includes a coupled CIEX/AIEX flow-through chromatography step. Employing a FT CIEX step in lieu of a traditional bind and elute step, required re-evaluation of other steps in the process.
Chris O'Brien, M.S., Supervisor, Purification Development, Agensys, Inc.
An internal effort to streamline purification process development and reduce manufacturing complexity resulted in a semi-continuous antibody purification process. This process employs a single buffer species and includes a coupled CIEX/AIEX flow-through chromatography step. Employing a FT CIEX step in lieu of a traditional bind and elute step, required re-evaluation of other steps in the process.
Chris O'Brien, M.S., Supervisor, Purification Development, Agensys, Inc.
Unpublished Data
8:45
Case
Study
Proof of Concept Evaluation of Sequential Multi-Column Chromatography with a Recombinant Therapeutic ProteinStudy
Continuous downstream purification processing is one area where technology development is required for the facility of the future. In this presentation, the experimental results of a Sequential Multi-Column Chromatography experiment will be presented. A recombinant therapeutic protein was purified on an affinity column in a bind and elute mode. The yield and host cell protein (HCP) clearance were comparable to the batch process. The productivity increased and the buffer consumption decreased in comparison to the batch process.
Janet Wendorf, Ph.D., Principal Engineer, Bayer Technology Services America
Unpublished Data
9:15
Continuous Chromatography: Purifying Monoclonal Antibodies in One Shot
A new purification process has been developed at Sanofi, enabling to run 3 chromatography steps in continuous mode with no holding time nor open phase. A cell culture bulk containing the monoclonal antibody can be now fully processed through this continuous process to obtain a pure monoclonal antibody batch without human intervention, decreasing also resin and buffer costs.
Laure Landric-Burtin, M.S., Head of Downstream Process Development, Sanofi R&D, Sanofi, France
A new purification process has been developed at Sanofi, enabling to run 3 chromatography steps in continuous mode with no holding time nor open phase. A cell culture bulk containing the monoclonal antibody can be now fully processed through this continuous process to obtain a pure monoclonal antibody batch without human intervention, decreasing also resin and buffer costs.
Laure Landric-Burtin, M.S., Head of Downstream Process Development, Sanofi R&D, Sanofi, France
9:45
Networking Refreshment Break
Non-Chromatographic Methods - Revisiting the Past?
Unpublished Data
10:15
Case
Study
High Productivity Non-Affinity Solutions for Purification of Therapeutic AntibodiesStudy
This case study will present data from two non-affinity-based purification procedures applied to a high producing anti-HER2 IgG cell line. Void exclusion anion exchange chromatography (VEAX) is column based and achieves roughly twice the throughput of protein A, at 5% the media cost per campaign. The other is based on steric exclusion chromatography (SXC) with inexpensive single-use particles. SXC is a non-column method that eliminates the productivity bottleneck of column-based capture, and supports processing of an entire cell culture batch in a single cycle. Both methods achieve host protein levels less than 200 ppm at capture. Both are followed by a single polishing step that reduces protein contamination to less than 1 ppm, and aggregates to less than 0.01%. IgG recovery ranges from 80 to 90%, depending on initial aggregate content. Both procedures potentially reduce overall downstream manufacturing costs by 30%, and preparation costs for clinical trial material by a factor of 3 compared to protein A-based platforms. Where the VEAX-based method is ideally suited for continuous chromatography applications, the SXC platform can be used effectively in either batch or continuous mode.
Pete Gagnon, M.S., Head of Downstream Processing, Bioprocessing Technology Institute, Singapore
Unpublished Data
10:45
Evolution of Bayer Platform Purification Processes for Recombinant Proteins and Monoclonal Antibodies by Implementing Membrane Absorber Technology
At Bayer, anion exchange membrane adsorber (MA) has been established as the platform technology for both direct capture of low titer unstable recombinant proteins and flow-through polishing of recombinant proteins and monoclonal antibodies. With its fast flow property, MA technology increases process efficiency over older generation processes. New salt tolerant MAs offer opportunities to further simplify the current platform processes.
Min Lin, Ph.D., Staff Development Scientist, Global Biological Development, Bayer HealthCare
At Bayer, anion exchange membrane adsorber (MA) has been established as the platform technology for both direct capture of low titer unstable recombinant proteins and flow-through polishing of recombinant proteins and monoclonal antibodies. With its fast flow property, MA technology increases process efficiency over older generation processes. New salt tolerant MAs offer opportunities to further simplify the current platform processes.
Min Lin, Ph.D., Staff Development Scientist, Global Biological Development, Bayer HealthCare
Unpublished Data
11:15
Case
Study
Reviewing Aqueous-Two-Phase-Extraction (ATPE) and Other Alternative Recovery and Purification ConceptsStudy
In search of effective approaches for recovery and/or purification of high protein mass batches methods that scale via concentration seem to be a better match to high product titers than chromatography or filtration where scale is proportional to protein mass and / or solids mass. We will compare technical features of alternatives including a cost comparison and will lead the thinking towards continuous processing as a means to address most challenges seemingly favoring the alternatives to current processing.
Günter Jagschies, Ph.D., Strategic Customer Relations Leader, GE Healthcare, Sweden
Concurrent Technology Workshops
11:45
High-titer feed-stocks and an increasing demand for separation of MAb variants (aggregates, fragments, charge variants, etc.) call for chromatography resins with new features. The focus here is to develop strategies for post Protein A polishing of various MAb purification challenges. New polishing resins, both ion-exchange and multi-modal resins, with high resolution will be compared regarding binding/elution conditions and ability to separate MAbs from impurities. Depending on the level of impurities, different processes including one or two polishing steps will be proposed.
Mats Gruvegard, Bioprocess Project Leader, GE Healthcare Life Sciences
Current biomanufacturing processes have reached a high degree of standardization and companies are working on the basis of proven technology platforms. While this helps to set up new purification trains in short timeframes, virus clearance concepts still require a thorough optimization to address economic challenges and product related characteristics. The tool box is getting bigger with different membrane types and features, different pre - filtration methods as well as product conditioning. This presentation will focus on different ways to optimize virus filtration to end up with a most efficient step.
Anika Meyer, Product Manager Virus Clearance, Sartorius Stedim Biotech GmbH, Germany
Luncheon Presentation (Space is limited)
12:15
Sponsored by
Next-Generation Clarisolve Technology for Clarification of Recombinant Proteins from High Cell Density Mammalian Cell Culture SystemsIncreasingly high cell density, high product titer cell cultures containing mammalian cells are being used for the production of recombinant proteins. These high productivity cultures are placing a larger burden on traditional downstream clarification and purification operations due to higher product and impurity levels. EMD Millipore aims to address this challenge by developing a proprietary Clarisolve technology to improve primary and secondary direct depth filtration of pre-treated high cell density mammalian cell cultures. Novel filter media designs with a deep gradient-density to provide a wide span of pore sizes, tuned to couple with particle sizes created by polymer flocculation or low pH precipitation techniques, have resulted in single stage clarification process for pre-treated cell culture suspensions.
Nripen Singh. Ph.D., Research Scientist III, EMD Millipore
Jonathan Romero, Ph.D., Associate Director, Biogen Idec, Inc.
Point/Counterpoint Discussion
1:30
Capture Options in Antibody Purification: Current Limitations, Emerging Options, and Obstacles to Change
Increasing batch sizes (protein mass) and cost seem to speak against the platform Protein A capture step. However, in future facilities bioreactor sizes are coming down and the step robustness is best in class. Cost arguably remains an issue in infrequent processing scenarios (clinical trials). Ion exchange is used for large scale capture of Mabs and many alternative routes (largely but not only non-chromatographic) have been tested, yet without a breakthrough success. We will discuss most known alternatives with their pros and cons
Moderator: Judy Glynn, M.S., Senior Principal Scientist, Biotherapeutics R&D, Pfizer Inc. (invited)
Panelists:
Pete Gagnon, M.S., Senior Research Technology Specialist, Bioprocessing Technology Institute, Singapore
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Günter Jagschies, Ph.D., Strategic Customer Relations Leader, GE Healthcare, Sweden
John Moscariello, Ph.D., Principal Scientist, Purification Process Development, Amgen, Inc.
John Pieracci, Ph.D., Associate Director, Purification Development, Biogen Idec
Abhinav Shukla, Ph.D., Vice President, Process Development and Manufacturing, KBI Biopharma
Increasing batch sizes (protein mass) and cost seem to speak against the platform Protein A capture step. However, in future facilities bioreactor sizes are coming down and the step robustness is best in class. Cost arguably remains an issue in infrequent processing scenarios (clinical trials). Ion exchange is used for large scale capture of Mabs and many alternative routes (largely but not only non-chromatographic) have been tested, yet without a breakthrough success. We will discuss most known alternatives with their pros and cons
Moderator: Judy Glynn, M.S., Senior Principal Scientist, Biotherapeutics R&D, Pfizer Inc. (invited)
Panelists:
Pete Gagnon, M.S., Senior Research Technology Specialist, Bioprocessing Technology Institute, Singapore
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Günter Jagschies, Ph.D., Strategic Customer Relations Leader, GE Healthcare, Sweden
John Moscariello, Ph.D., Principal Scientist, Purification Process Development, Amgen, Inc.
John Pieracci, Ph.D., Associate Director, Purification Development, Biogen Idec
Abhinav Shukla, Ph.D., Vice President, Process Development and Manufacturing, KBI Biopharma
3:15
Grand Opening of the Poster and Exhibit Hall with Refreshments
Sponsored by
Keynote Presentations
4:00
Chairman's Remarks
Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec
Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec
4:15
Producing High Quality, Low Cost Biotherapeutics in the Century of BiologyOver the last 30 years there have been substantial advancements in the manufacture of protein therapeutics. For example, product titers have been increased by more than four orders of magnitude using mammalian expression systems. Today we have the capability of producing metric tons of relatively low cost complex biologics; enough to meet the most demanding therapeutic markets. While some believe our advancements in this field are reaching a plateau, the century of biology will provide the knowledge and tools for even greater innovation for those willing to invest.
James Thomas, Ph.D., Vice President, Process and Product Development and WA Site Head, Amgen, Inc.
4:50
A Systems Approach to Managing Biomanufacturing Complexity - Genzyme's Allston Plant Case StudySandra Poole, Senior Vice President Biologics Operations, Genzyme
5:25
Transforming the Development of Biotechnology Drugs for the 21st Century: A CEO's Perspective from a Small Biotech CompanyIn these times of growing unmet medical need driven innovation in drug development is needed more than ever. Rapid translation of ideas into high value drugs that move rapidly from the bench to the bedside requires the perfect blending of science, medicine, policy and capital. While efficacy and safety will continue to be the key drivers of value, other factors driving healthcare impact, outcomes and cost will have to be more proactively integrated into drug discovery and drug development. The small biotech company will continue to be a critical component of the solution to these challenges.
Abbie Celniker, Ph.D., CEO, Eleven Biotherapeutic
6:00
Wine and Cheese Reception in Poster and Exhibit Hall
Sponsored by
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:30
Coffee
Technology Workshop with Light Continental Breakfast
7:30
While single-use and disposable technologies are prevalent in many areas within upstream and downstream processing, up until now there has not been a broadly applicable solution for chromatography steps. In this presentation, best practices for implementing pre-packed disposable columns in clinical manufacturing will evaluated, and a case study from a recent GMP manufacturing implementation will be presented.
Stephen Tingley, Vice President, Bioprocessing, RepliGen
8:00
Chairman's Remarks
Carsten Voss, Ph.D., Application Specialist, Process Chromatography, Bio-Rad Laboratories, Germany
Carsten Voss, Ph.D., Application Specialist, Process Chromatography, Bio-Rad Laboratories, Germany
Purification Advances using Mixed-Mode Chromatography
Sponsored by
Unpublished Data
8:15
Molecular Insights into Multimodal Chromatography
Steven Cramer, Ph.D., Walker Professor, Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute
Steven Cramer, Ph.D., Walker Professor, Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute
Unpublished Data
8:45
Case
Study
Mixed-Mode Chromatography Technology in Monoclonal Antibody Downstream Purification ProcessStudy
In this presentation, we introduce a new methodology, the mode tuning concept, for multimodal chromatographic process development. It is demonstrated that the multimodal nature of ligands on mixed-mode resins allows the separation resolution to be honed, either through a single dominant mechanism or through mix-modal balanced purification strategies depending on the chemical properties of separation resin and product of interest. Through case studies we will address the process throughput benefits, the unique separation resolution advantages offered by multimodal chromatographic resins, and their potential application for both capture and polishing step of downstream purification process.
Jie Chen, MD, M.S., Director of Protein Sciences, Dyax Corp.
Unpublished Data
9:15
Case
Study
Overcoming Proteolytic Degradation During the Purification of a Therapeutic GlycoproteinStudy
Severe proteolysis was discovered as the main cause for target protein loss, during the purification of a glycosylated therapeutic enzyme from Chinese hamster ovary cell culture harvest. Using a sequential mixed-mode chromatography workflow in combination with efficient inhibition of proteolysis in situ, we have greatly improved the yield of this enzyme.
Xuemei He, Ph.D., Senior Staff Scientist, Process Chromatography Applications, Bio-Rad Laboratories
9:45
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Unpublished Data
10:30
Case
Study
Strategies to Overcome Bispecific Antibody Purification Challenges Using Novel Mixed Mode ChromatographyStudy
Kenneth Kang, Ph.D., Principal Scientist, Head of Purification Team, BioProcess Sciences, ImClone Systems, A wholly-owned subsidiary of Eli Lilly and Company
Unpublished Data
11:00
Case
Study
A Comparison of Protein A and Mixed-Mode Chromatography for the Purification of Monoclonal AntibodiesStudy
Protein A has been used widely as a matrix for the purification of therapeutic antibodies. Low pH elution from this resin sometimes affects antibody properties. In comparison, mixed-mode chromatography provides a gentle way of purifying monoclonal antibodies. A case study shows the benefits of switching to mixed-mode chromatography, as well as some trade-offs.
Jit Ray, Ph.D., Deputy Director, Protein Chemistry, Sanofi Pasteur
Unpublished Data
11:30
Case
Study
The Uses of HIC and Multimodal Chromatography in the Purification of Bioconjugate Whose Components are Expressed in E.coli and CHOStudy
Shuang Chen, Ph.D., Senior Scientist, Purification Process Development, Pfizer Inc.
Concurrent Technology Workshops
12:00
Chris Shields, Marketing Manager, Single Use Systems, Saint-Gobain Life Science
With an increased focus on process efficiency and quality, once considered basic cell culture processes are under further scrutiny. The presentation will outline how improved process control, automation and smart sensors can maximize efficiency while increasing quality and repeatability. Once considered basic operations such as seed train and cell banking will be examined.
Richard Ferraro, Business Leader WAVE Products Group, GE Healthcare
One of the key trends in bio-manufacturing is the move from the production of small molecule drugs to biologics and cellular therapies. In this environment, single-use technology platforms are a key enabler for increasing productivity and reducing costs. Here we discuss the benefits of disposable solutions, including novel scale-up vessels with specialized surfaces and custom media formulations.
Richard M. Eglen, Ph.D., Vice President & General Manager, Corning Life Sciences
12:30
Networking Luncheon in Poster and Exhibit Hall
1:45
Chairman's Remarks
David W. Kahn, Ph.D., Senior Director, GlaxoSmithKline
David W. Kahn, Ph.D., Senior Director, GlaxoSmithKline
Purification Strategies for Novel Modalities and High Density Cell Cultures
Unpublished Data
2:00
Case
Study
Process Design of Non-Antibody PurificationStudy
Thomas Boehm, Ph.D., Principal Scientist, Protein Purification & Analytics, Amgen Research, Germany
2:30
Downstream Strategies for High Density Cell Cultures
Gregory Zarbis-Papastoitsis, Ph.D., Senior Director, Protein Production and Analytical Development, Eleven Biotherapeutics
Gregory Zarbis-Papastoitsis, Ph.D., Senior Director, Protein Production and Analytical Development, Eleven Biotherapeutics
Unpublished Data
3:00
Expanded Bed Adsorbance Processing for High-Density Mammalian Cultures: Process Parameters and Performance
We will describe the use of Expanded Bed adsorption for use with high-density and high-titer feedstreams. Expanded Bed Adsorption (EBA) is a chromatographic technique which makes processing of viscous and particulate liquids possible. Whereas traditional column chromatography uses a solid phase constituted by a packed bed, EBA uses a fluidized bed. Particles such as whole cells or cell debris, which would quickly clog a packed bed column, easily pass through a fluidized bed using a rotating fluid distributor (RFD). Therefore, EBA columns can be used directly for crude, high cell density or highly viscous feed streams. Cells and/or debris flow through the expanded bed and product is bound thereby bypassing initial clarification steps such as centrifugation and filtration.
Piet den Boer, Ph.D., Senior Scientist, DSM Biologics
We will describe the use of Expanded Bed adsorption for use with high-density and high-titer feedstreams. Expanded Bed Adsorption (EBA) is a chromatographic technique which makes processing of viscous and particulate liquids possible. Whereas traditional column chromatography uses a solid phase constituted by a packed bed, EBA uses a fluidized bed. Particles such as whole cells or cell debris, which would quickly clog a packed bed column, easily pass through a fluidized bed using a rotating fluid distributor (RFD). Therefore, EBA columns can be used directly for crude, high cell density or highly viscous feed streams. Cells and/or debris flow through the expanded bed and product is bound thereby bypassing initial clarification steps such as centrifugation and filtration.
Piet den Boer, Ph.D., Senior Scientist, DSM Biologics
3:30
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Keynote Presentations
4:15
Chairwoman's Remarks
Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
4:25
Biologics Manufacturing in a Rapidly Changing EnvironmentThe environment for Biopharmaceutical manufacturing is rapidly changing. While the overall market is still growing rapidly, challenges in development coupled with increasing yields have resulted in significant overcapacity in manufacturing. At the same time disposable manufacturing approaches have made significant advances, while new biologics entering the market have seen slow adoption due to pricing/reimbursement issues and conservative prescribing by physicians. Dr. Moesta will discuss Bristol-Myers Squibb's portfolio of Biologics and the positioning of its manufacturing network in this dynamic environment.
Peter Moesta, Ph.D., Senior Vice President, Biologics Manufacturing & Process Development, Bristol-Myers Squibb Co.
5:05
Eliminating Interfaces: Process Development Lessons from Aggressive Platform DevelopmentPlatform approaches have yielded dramatic gains in speed and savings in the business of process development, most notably for antibody products. And it doesn't end there: increasingly we see platforms driving change in the organizational and scientific domain, up to and including a re-definition of the role of the process scientist itself. But how marry the core drivers of platform success - standardization and templating - with the needs of tomorrow's increasingly diverse pipelines?
Lars Pampel, Ph.D., Group Head, Early Phase Process Development, Novartis Pharma AG, Switzerland
5:45
Wine and Cheese Reception in Poster and Exhibit Hall
Co-Sponsored by
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:30
Coffee
8:00
Chairman's Remarks
Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme, a Sanofi Company
Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme, a Sanofi Company
Innovation at the Interface of Upstream and Downstream Processing
Unpublished Data
8:15
Case
Study
Integrated and Fully Continuous Processing of Recombinant Therapeutic ProteinsStudy
Our data reveal that an integrated fully continuous process results in a dramatic increase in the process throughput, decrease in the equipment footprint, elimination of several non-value added unit operations, elimination of hold steps and reduced the number of unit operations to minimum. These findings also demonstrate the potential of integrated fully continuous bioprocessing as a universal platform for the manufacture of various kinds of therapeutic proteins.
Veena Warikoo, Ph.D., Department Head, Purification Development, Late Stage Process Development, Genzyme, A Sanofi Company
Unpublished Data
8:45
Case
Study
Head-to-Head Comparison of the Disc Stack and Fluidized Bed Centrifuges to Clarify a Biopharmaceutical ProductStudy
This presentation is a comparison of Disc Stack Centrifuge and Fluidized Bed Centrifuge technologies to clarify a biopharmaceutical product. The DSC and FBC will be evaluated based on harvest parameters such as clarification efficiency and product recovery, along with an analysis of the impact of each technology on cell health due to shear within the system. Cost and equipment turnaround are also compared.
Jason Condon, M.S., Scientist, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development
Unpublished Data
9:15
Case
Study
Clarification of Recombinant Proteins from High Cell Density Mammalian Cell Cultures Systems using Disposable TechnologiesStudy
To address the challenges of processing high cell density mammalian cell cultures systems from batch processes, disposable clarification technologies such as Depth filtration, Tangential flow filtration, and fluidized bed centrifugation are compared for harvesting of untreated and flocculated high cell density feeds. Results will highlight the benefits and limitations of these technologies both from a processing performance perspective and an operational and economical Cost model analysis. A framework will be presented for optimizing disposable clarification technology and cost during scale-up into a GMP setting.
Jonathan Romero, Ph.D., Associate Director, Global Manufacturing Engineering, Biogen Idec
Unpublished Data
9:45
Case
Study
Development of Novel and Efficient Cell Culture Flocculation Process Using a Stimulus Responsive Polymer to Streamline Antibody Purification ProcessStudy
Kenneth Kang, Ph.D., Principal Scientist, Head of Purification Team, BioProcess Sciences, ImClone Systems, A wholly-owned subsidiary of Eli Lilly and Company
10:15
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Expanding the Tool Box - Novel Purification Methods and Single-Use Applications
Sponsored by
Chairwoman: Christine Gebski, M.S., Head, POROS Business Unit and Global Applications, Life Technologies
Unpublished Data
11:00
Case
Study
The Road to Commodity mAb Processing Via Emerging Purification TechnologiesStudy
Opportunities for applying new technologies integrated with continuous processing and enabled by single use will be discussed for monoclonal antibody production. This will include experimental evaluations of single use options for centrifugation, continuous chromatography inconjunction with novel next generation purification approaches. The combined efficiencies gained by continuous processing, using integrated upstream and purification, will be discussed with approaches for smaller, multi product manufacturing facilities.
David Pollard, Ph.D., Executive Director, Merck & Co., Inc.
Unpublished Data
11:30
Case
Study
Advancements in Single-Use Technology for Downstream Purification - A Case Study Utilizing Novel Single-Use Hydrogel Technology for Purification of an IgG1Study
In this study we compared a novel single-use cation hydrogel technology to both protein A and cation exchange resins as an initial bind-elute capture step. The influence of pH, salt concentration and flow rate on dynamic binding capacities, yield and host cell protein removal was determined for each capture step. This information was used to optimize a three-step, non-Protein A monoclonal antibody purification process and was compared to a commercially manufactured process utilizing MabSURE resin for the capture step. These results suggest that both the single-use hydrogel cation technology and cation exchange resin have higher binding capacities and comparable yields to MabSURE resin as a capture step with host cell protein removal being lower for both cation exchange technologies. In addition, single-use anion exchange hydrogel technology in a flow-through mode may provide a reasonable alternative to columns for the removal of host cell protein and virus.
Ryan Crisman, Ph.D., Scientist, Downstream Process Development, CMC Biologics
Concurrent Technology Workshops
12:00
This session will focus on downstream applications for the Emphaze™ Hybrid Purifier , a new bioprocess purification platform that integrates anion exchange hydrogel chromatography and size exclusion membrane into a single-use, scalable device format.
Michael Wang, Ph.D., Advanced Technical Specialist, 3M Purification Inc.
Challenges in cell line development include: how to explore sufficient cell lines to identify clones with optimal protein expression; how to perform Design of Experiment (DoE) analyses with suitable power to identify relevant culture parameters; and how to explore more cell line candidates and culture conditions to enable better, faster decision making. This session is an overview of TAP Biosystems' advanced microbioreactor (ambr™) technology, with industry derived data that demonstrate ambr's suitability for cell culture optimization, in the context of biotherapeutics development.
Barney Zoro, Product Manager, TAP Biosystems, United Kingdom
Protein A affinity chromatography continues to be the workhorse in the purification of therapeutic monoclonal antibodies (mAb). The highly specific interaction between Protein A and an antibody's Fc region provides high product yield while also ensuring that more than 99% of impurities from clarified cell culture are removed. EMD Millipore introduces a novel Protein A chromatography resin that delivers high performance stability under extreme pH conditions. Additionally, this new resin is distinct from current commercially available Protein A resins in its unique ability to remove high molecular weight (HMW) species from a mAb feed. The added benefits of this new resin are delivered along with the high dynamic binding capacity and impurity removal capabilities expected from a modern Protein A resin.
Nanying Bian, Ph.D., EMD Millipore
12:30
Networking Luncheon and Last Chance for Exhibit and Poster Viewing in Poster and Exhibit Hall
1:40
Chairwoman's Remarks
Christine Gebski, M.S., Head, POROS Business Unit and Global Applications, Life Technologies
Christine Gebski, M.S., Head, POROS Business Unit and Global Applications, Life Technologies
Unpublished Data
1:45
PEGylating Protein A Media: Increasing Selectivity for MAbs by Decreasing Non-Specific Binding
PEGylation is used to make therapeutic proteins "stealthy" while preserving biological activity in vivo; we applied this same technology to make Protein A media "stealthy" in affinity chromatography columns. An initial naïve PEGylation approach applied to a commercial Protein A media resulted in several-fold increases in selectivity. Static binding capacity was preserved while hindered pore diffusion reduced dynamic binding capacity.
Todd M. Przybycien, Ph.D., Professor of Chemical Engineering and Biomedical Engineering, Department of Chemical Engineering, Carnegie Mellon University
PEGylation is used to make therapeutic proteins "stealthy" while preserving biological activity in vivo; we applied this same technology to make Protein A media "stealthy" in affinity chromatography columns. An initial naïve PEGylation approach applied to a commercial Protein A media resulted in several-fold increases in selectivity. Static binding capacity was preserved while hindered pore diffusion reduced dynamic binding capacity.
Todd M. Przybycien, Ph.D., Professor of Chemical Engineering and Biomedical Engineering, Department of Chemical Engineering, Carnegie Mellon University
Unpublished Data
2:15
Case
Study
Combining Superior Capacity, Resolution and Salt Tolerance: A Novel Strong Anion Exchange ResinStudy
POROS® XQ is a new strong, fully quarternized amine, anion exchange resin designed with high dynamic binding capacity, strong salt tolerance and excellent resolution properties. POROS XQ provides > 150mg/mL capacity at 50mM salt and > 100mg/ml capacity at 100mM salt, allowing for high performance in capture and polish applications for recombinant proteins and monoclonal antibodies. Applications data will be utilized to demonstrate the performance features of this new resin. In addition process modeling will be used to demonstrate cost of goods improvements and process efficiencies that can be realized with this high performance strong AEX resin.
Shelly Parra, Senior Field Applications Scientist, Bioproduction, Life Technologies
Unpublished Data
2:45
Expanding the Purification Toolbox Using Single-Pass Tangential Flow Filtration
Single-pass tangential flow filtration (SPTFF) is a unique concentration method, which can expand purification options beyond traditional biopharmaceutical processes. Integration of SPTFF into purification processes can enable coupled/continuous processing, facilitate process debottlenecking and improve facility fit, ultimately extending the capability of existing manufacturing facilities and enabling purification processes of the future.
Matthew Westoby, Senior Engineer II, Technical Development, Biogen Idec
Single-pass tangential flow filtration (SPTFF) is a unique concentration method, which can expand purification options beyond traditional biopharmaceutical processes. Integration of SPTFF into purification processes can enable coupled/continuous processing, facilitate process debottlenecking and improve facility fit, ultimately extending the capability of existing manufacturing facilities and enabling purification processes of the future.
Matthew Westoby, Senior Engineer II, Technical Development, Biogen Idec
3:15
Networking Refreshment Break
Advances in Analytics & Models to Aid Downstream Process Development
3:45
Automation of Analytical Assays to Support High Throughput in Process Development of Biologics
Xiaodun (Susan) Mou, Ph.D., Associate Principal Scientist, Merck & Co., Inc.
Xiaodun (Susan) Mou, Ph.D., Associate Principal Scientist, Merck & Co., Inc.
Unpublished Data
4:15
Case
Study
High-Throughput Small-Scale Ion Exchange Protein PurificationStudy
High-throughput small scale purification (HTP-SSP) is required for product quality analyses in cell line and bioprocess development. Here, we present a two-step HTP-SSP using ion exchange resins to purify a basic protein in cell culture samples containing a polyanionic compound. The HTP-SSP can purify the protein with ~80% yield without affecting product quality attributes.
Lam Raga Anggara Markely, Ph.D., Scientist I, Cell Culture Development, High-Throughput Analytical Group, Biogen Idec
Unpublished Data
4:45
Case
Study
Characterization of Impurity Isoforms Using Advanced Analytical Technologies to Improve Critical Chromatography Step for Recombinant Protein TherapeuticsStudy
While most protein impurities are easily removed during the purification process, certain animal products can provide challenges due to its similar properties to the protein therapeutics. It was observed that variation in protein impurity isoforms can contribute to its effective removal. Differentiate and track protein impurity isoforms by LC/MS and cIEF immunoassay can help optimization of the critical chromatography step.
Melanie Lin, Ph.D., Senior Scientist, Shire Pharmaceuticals
5:15
Close of BioProcess International™ Conference & Exhibition 2013
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