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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Recovery & Purification
Recovery & Purification
- 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
7:00
Registration and Coffee
Recovery & Purification
8:00
Chairperson's Remarks
Gary J. Welch, Director, Process Science, Abbott Bioresearch Center
Gary J. Welch, Director, Process Science, Abbott Bioresearch Center
Advances in Process Monitoring and Control in Downstream Processing
8:15
Evaluation of Raman Spectroscopy for Purification Operations
Raman spectroscopy is one of the powerful quantitative techniques that is amenable to analysis of biological process solutions. It is capable of providing accurate quantitation of multiple components in a solution with minimal sample preparation, and often able to be used as an in-line or at-line monitoring tool. Evaluation of this technique for preparation and release of buffers, control of excipient levels during formulation and other downstream operations will be presented.
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
Raman spectroscopy is one of the powerful quantitative techniques that is amenable to analysis of biological process solutions. It is capable of providing accurate quantitation of multiple components in a solution with minimal sample preparation, and often able to be used as an in-line or at-line monitoring tool. Evaluation of this technique for preparation and release of buffers, control of excipient levels during formulation and other downstream operations will be presented.
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
8:45
On-line HPLC as a PAT for Controlling Product Collection from Process Scale Chromatography Columns
Large scale chromatography is a widely used unit operation in peptide and protein manufacturing. Variability in the elution of these process columns makes it difficult to know precisely where to start and stop collecting the product pool. On-line HPLC based analyzers are a PAT that provides product purity information enabling automated control of product pool collection with increased yield, decreased product variability, and decreased cycle time.
Rick E. Cooley, Market Development Manager, Process Analytics, Dionex Corporation
Large scale chromatography is a widely used unit operation in peptide and protein manufacturing. Variability in the elution of these process columns makes it difficult to know precisely where to start and stop collecting the product pool. On-line HPLC based analyzers are a PAT that provides product purity information enabling automated control of product pool collection with increased yield, decreased product variability, and decreased cycle time.
Rick E. Cooley, Market Development Manager, Process Analytics, Dionex Corporation
9:15
Using Multivariate Batch Process Monitoring and Soft Sensors for Advanced Process Control in Commercial Scale Purification Operations
Multivariate Biopharmaceutical Batch Process Modeling and Monitoring is evolving as a key Process Analytical Technology (PAT) to enable real-time design space monitoring to support Quality-by-Design paradigm. The use of this technology for bioprocess supervision, troubleshooting, process understanding, and control at commercial-scale manufacturing will be summarized. Incorporating this technology with the use of soft-sensors will also be discussed, with industrial examples.
Thomas Mistretta, M.S., Senior Engineer, Process Development, Amgen Inc.
Multivariate Biopharmaceutical Batch Process Modeling and Monitoring is evolving as a key Process Analytical Technology (PAT) to enable real-time design space monitoring to support Quality-by-Design paradigm. The use of this technology for bioprocess supervision, troubleshooting, process understanding, and control at commercial-scale manufacturing will be summarized. Incorporating this technology with the use of soft-sensors will also be discussed, with industrial examples.
Thomas Mistretta, M.S., Senior Engineer, Process Development, Amgen Inc.
9:45
Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
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.
Plenary Session
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
Keynote Presentations
Chairperson: Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
4:00
Sustainable Commercial Cell Culture OperationsDeveloping a cell culture process which delivers a product with defined and acceptable critical quality attributes is but the first, and in many respects the easiest, element in the product lifecycle. Maintaining performance, ensuring the currency of the technical foundation and improving productivity and efficiency become the key challenges in having a sustainable operation. Knowledge is perishable; establishing routine can maintain performance but inhibit improvement; and everything ages. Hear about the systems that can be put in place to deal with these concepts across People, Process and Infrastructure.
W. Blair Okita, Ph.D., Senior Vice President, Manufacturing Sciences and Technical Operations, Genzyme Corporation
4:45
Finding a Home for Process and Product DevelopmentIn order to compete in today's cost-conscious world, the biotechnology industry needs to reinvent itself. Recognition of Manufacturing Technology and Product Development as a critical strategic element in this reinvention process and putting in place organizational design which enables their contributions are key to ultimate success. Process and product development are effectively carried out within the biotechnology industry under a number of different organizational designs (OD). The presentation will address, through example and guiding principles, where OD can enable game-changing outcomes.
S. Robert Adamson, Ph.D., Advance Biotech Consultants; former Senior Vice President Product and Process Development, Wyeth Biopharma
5:30
Networking Cocktail Reception in Exhibit and Poster Hall
Sponsored by
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Coffee
Plenary Session
Recovery & Purification
Breakthroughs to De-Bottleneck Downstream Processing
Chairperson: Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & Purification Department, Global Biological Development, Bayer HealthCare
10:30
Evaluation of Single Pass TFF to Debottleneck Downstream Processing of Monoclonal Antibodies
Single Pass Tangential Flow Filtration (SPTFF) is a novel technology that can significantly improve downstream processing capacity and yields. In this presentation, we will compare SPTFF with conventional TFF and show proof-of-concept data on reducing pool volumes with multiple monoclonal antibody molecules. An implementation strategy to debottleneck downstream capability in commercial manufacturing will also be discussed.
Jemelle Dizon-Maspat, Senior Research Associate, Genentech, Inc.
Single Pass Tangential Flow Filtration (SPTFF) is a novel technology that can significantly improve downstream processing capacity and yields. In this presentation, we will compare SPTFF with conventional TFF and show proof-of-concept data on reducing pool volumes with multiple monoclonal antibody molecules. An implementation strategy to debottleneck downstream capability in commercial manufacturing will also be discussed.
Jemelle Dizon-Maspat, Senior Research Associate, Genentech, Inc.
11:00
Downstream Breakthroughs in Downstream Processing of High Titer and Cell Density Harvests
Use of the PER.C6® cell line resulted in 27 g/L of antibody in XD®, and 10 g/L in Fed-Batch. These high titers and accompanying high cell densities create challenges for downstream processing. Here we present high capacity and single use technologies developed to answer some of these challenges. These techniques enable speed, flexibility, and smaller facilities. The final product quality is equal or better to traditional processes.
Blanca Lain, Senior Scientist, Downstream Process Development, Percivia, LLC
Use of the PER.C6® cell line resulted in 27 g/L of antibody in XD®, and 10 g/L in Fed-Batch. These high titers and accompanying high cell densities create challenges for downstream processing. Here we present high capacity and single use technologies developed to answer some of these challenges. These techniques enable speed, flexibility, and smaller facilities. The final product quality is equal or better to traditional processes.
Blanca Lain, Senior Scientist, Downstream Process Development, Percivia, LLC
11:30
Process Design and Facility Fit Optimization Models for Higher Titer Purification of Monoclonal Antibodies
Genentech has developed two generations of facility fit models covering a commercial manufacturing network with 6 production sites. We present an overview of the models which, based on equipment and operational constraints, identify site-specific bottlenecks, recoverable titer ranges and optimal processing parameters. We further show how their use has enabled the design of a very high productivity (Kg/batch) process concept.
Nuno Fontes, Ph.D., Senior Engineer, Group Leader, Genentech, Inc.
Genentech has developed two generations of facility fit models covering a commercial manufacturing network with 6 production sites. We present an overview of the models which, based on equipment and operational constraints, identify site-specific bottlenecks, recoverable titer ranges and optimal processing parameters. We further show how their use has enabled the design of a very high productivity (Kg/batch) process concept.
Nuno Fontes, Ph.D., Senior Engineer, Group Leader, Genentech, Inc.
12:30
Networking Luncheon in Exhibit and Poster Hall
Exhibit Hall Presentation
1:00
The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies can Still Fall ShortBP’s oil disaster in the Gulf shows how decisions and events can impact global organizations. Genzyme was hit with a virus that was undetectable by the industry’s standard viral tests and led to a global shortage in supply of critical medicines. During this presentation, Mark Bamforth will reflect on the importance of relentlessly pursuing Operational Excellence and how events can still impact an organization.
Mark R. Bamforth, President & CEO, Gallus Biopharmaceuticals; Former Senior Vice President, Corporate Operations and Pharmaceuticals, Genzyme Corporation
Recovery & Purification
1:45
Chairperson's 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
Implementing the Latest Tools and Techniques to Optimize the Harvest Step
2:00
Optimization of the Harvest Step
Cell culture harvest often involves centrifugation and filtration operations. The requirements for the filters depend on the size and amount of particles which remain suspended in the broth after centrifugation. Particle-size analysis of benchtop centrifuge clarification runs gives information which can be used for specification of the filters and for optimization without needing to gather data at the production scale.
Roy Hegedus, Ph.D., Senior Scientist, Purification, Process Sciences, Abbott Bioresearch Center
Cell culture harvest often involves centrifugation and filtration operations. The requirements for the filters depend on the size and amount of particles which remain suspended in the broth after centrifugation. Particle-size analysis of benchtop centrifuge clarification runs gives information which can be used for specification of the filters and for optimization without needing to gather data at the production scale.
Roy Hegedus, Ph.D., Senior Scientist, Purification, Process Sciences, Abbott Bioresearch Center
2:30
Enabling Precipitation as an Operation to Manage Critical Contaminants in Bioprocessing
Precipitation is a versatile technique for contaminant removal and product capture but not commonly used in the production of biologics. Reasons cited for this surround difficulty in finding the desired yield and purity. This dogma is removed if we adopt techniques to accelerate this search process, enabling evaluation of the large design spaces that result from combinations of precipitation agents.
Daniel G. Bracewell, Ph.D., M.S., Department of Biochemical Engineering, University College London, United Kingdom
Precipitation is a versatile technique for contaminant removal and product capture but not commonly used in the production of biologics. Reasons cited for this surround difficulty in finding the desired yield and purity. This dogma is removed if we adopt techniques to accelerate this search process, enabling evaluation of the large design spaces that result from combinations of precipitation agents.
Daniel G. Bracewell, Ph.D., M.S., Department of Biochemical Engineering, University College London, United Kingdom
3:00
Exploring Expanded Bed Adsorption for Capture of Antibodies from CHO Cultures
A New Protein A based expanded bed adsorption chromatography media was examined as a method of capture for monoclonal antibodies from CHO cell cultures. Purification performance of this resin was examined relative to conventional protein A chromatography. Capacity, cleaning alternatives, and stability of the resin in cleaning and storage solutions are examined.
Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics
A New Protein A based expanded bed adsorption chromatography media was examined as a method of capture for monoclonal antibodies from CHO cell cultures. Purification performance of this resin was examined relative to conventional protein A chromatography. Capacity, cleaning alternatives, and stability of the resin in cleaning and storage solutions are examined.
Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Overcoming Challenges of Production, Purification and Characterization of Next Generation Antibody-Like Molecules & Protein Therapeutics
4:00
Case
Study
Investigation into the Concentration Limit of a PEGylated ProteinStudy
This study illustrates concentration limitations for a mono PEGylated protein. The desired PEGylated protein concentration was 60mg/ml but only 24 mg/ml was achieved by UF/DF. We demonstrated that the protein could be concentrated to >60mg/ml while linear PEG could be concentrated to 25 or 35 mg/ml in formulation buffer or WPU, respectively, demonstrating that PEG was the limiting concentration factor.
Sarah Holtschlag, M.S., Senior Scientist, Downstream Process Development, Diosynth Biotechnology
4:30
Assembly and Purification of Knob and Hole Bispecific Antibodies
Abstract not available at press date.
Josefine Persson, Ph.D., Scientist, Early Stage Purification, Genentech, Inc.
Abstract not available at press date.
Josefine Persson, Ph.D., Scientist, Early Stage Purification, Genentech, Inc.
5:00
Applications for Biopharmaceuticals in Regenerative Medicine
Many biopharmaceuticals and biological products are designed to block disease pathways or replace missing factors but there is a growing interest in their application to regenerative medicine wherein biological systems are restored to their healthy state. This presentation will discuss some of the manufacturing and analytical challenges that are specific to products for regenerative medicine.
Peter W. Wojciechowski, Ph.D., Director, Product and Process Development, Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Many biopharmaceuticals and biological products are designed to block disease pathways or replace missing factors but there is a growing interest in their application to regenerative medicine wherein biological systems are restored to their healthy state. This presentation will discuss some of the manufacturing and analytical challenges that are specific to products for regenerative medicine.
Peter W. Wojciechowski, Ph.D., Director, Product and Process Development, Advanced Technologies and Regenerative Medicine, LLC (ATRM)
5:30
Immunodrugs™ - Development of a New Class of Therapeutic Vaccines
Cytos Biotechnology is developing a new class of vaccines (ImmunodrugsTM) targeting several indications including major chronic diseases. By highly repetitive presentation of disease-related proteins on the surface of virus like particles (VLPs), Immunodrugs™ elicit a potent immune response against said disease-related proteins with the potential to offer therapeutic benefits. The concept, production and application of Immunodrugs™ will be presented.
Frank Hennecke, Ph.D., Executive Vice President, Product Development, Cytos Biotechnology, Switzerland
Cytos Biotechnology is developing a new class of vaccines (ImmunodrugsTM) targeting several indications including major chronic diseases. By highly repetitive presentation of disease-related proteins on the surface of virus like particles (VLPs), Immunodrugs™ elicit a potent immune response against said disease-related proteins with the potential to offer therapeutic benefits. The concept, production and application of Immunodrugs™ will be presented.
Frank Hennecke, Ph.D., Executive Vice President, Product Development, Cytos Biotechnology, Switzerland
6:00
Close of Day
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:30
Coffee
Recovery & Purification
8:00
Chairperson's Remarks
Pete Gagnon, MS., Chief Scientific Officer, Validated Biosystems
Pete Gagnon, MS., Chief Scientific Officer, Validated Biosystems
Evaluation and Implementation of Next Generation Purification Technologies
8:15
Case
Study
Strategies to Address Clarification of High Concentration Refold Pools for E. coli Based TherapeuticsStudy
Abstract not available at press date.
Xuankuo Xu, Ph.D., Scientist, Process Science Downstream, Bristol-Myers Squibb
8:45
Evaluation and Implementation of New Alternatives to Standard Anion Exchange Resins and Membranes
Standard industry monoclonal antibody purification processes generally include an anion exchange unit operation. Historically this has utilized a chromatography resin, but new flavors of antibody molecules in conjunction with the drive towards lower cost-of-goods and streamlined processes have led to development of alternative media forms such as membranes in flat sheet or hollow fiber configurations. This presentation will focus on evaluation of new anion exchange technologies that could improve robustness and flexibility of purification processes, presenting a comparison in terms of yield and specificity as well as robustness in a platform process.
Judy Glynn, M.S., Senior Principal Scientist, BioTherapeutics R&D, Pfizer Inc</span>
Standard industry monoclonal antibody purification processes generally include an anion exchange unit operation. Historically this has utilized a chromatography resin, but new flavors of antibody molecules in conjunction with the drive towards lower cost-of-goods and streamlined processes have led to development of alternative media forms such as membranes in flat sheet or hollow fiber configurations. This presentation will focus on evaluation of new anion exchange technologies that could improve robustness and flexibility of purification processes, presenting a comparison in terms of yield and specificity as well as robustness in a platform process.
Judy Glynn, M.S., Senior Principal Scientist, BioTherapeutics R&D, Pfizer Inc</span>
9:15
Bioengineered Protein A Polymer Beads for High-Affinity Antibody Purification
Bacterial cells were engineered to cost-effectively produce polyester beads displaying the IgG binding ZZ domain of protein A at high density. The ZZ domain is part of a fusion protein which remains naturally cross-linked to the polyester core of the beads. The performance of these beads in antibody purification and their proposed use as disposable purification media will be discussed.
Bernd H. A. Rehm, Ph.D., Chief Scientific Officer, PolyBatics Ltd, New Zealand
Bacterial cells were engineered to cost-effectively produce polyester beads displaying the IgG binding ZZ domain of protein A at high density. The ZZ domain is part of a fusion protein which remains naturally cross-linked to the polyester core of the beads. The performance of these beads in antibody purification and their proposed use as disposable purification media will be discussed.
Bernd H. A. Rehm, Ph.D., Chief Scientific Officer, PolyBatics Ltd, New Zealand
9:45
Networking Refreshment Break
Process Characterization for Developing Design Space
10:15
Challenges of Technology Transfer Exacerbated by a Small Scale Model Artifact
Abstract not available at press date.
Marcus P. Luscher, Scientist, Purification Process Development, Amgen Inc.
Abstract not available at press date.
Marcus P. Luscher, Scientist, Purification Process Development, Amgen Inc.
10:45
Case
Study
Accelerated Methionine Oxidation Due to Viral Filtration? A Case Study of the Limitations of Small Scale ModelsStudy
An accelerated stability study of protein solutions subjected to small-scale viral filtration found that viral filtered samples exhibited a higher rate of methionine oxidation compared with unfiltered controls. A series of troubleshooting studies were performed to determine if the source of the accelerant of methionine oxidation is the small-scale viral filter or the bench-scale viral filtration pressure apparatus.
Tom Strickland, Ph.D., Principal Scientist, Purification Process Development, Amgen Inc.
11:15
Case
Study
Downstream Process Characterization for a Highly Glycosylated Fc-Fusion ProteinStudy
Glycosylation represents one of the most common yet complex post-translational modifications for protein biopharmaceuticals. Here we describe a case study on downstream process characterization for a highly glycosylated Fc-fusion protein. Results of this study were employed to establish a hydrophobicity specification for the HIC resin, harvest criterion for the production bioreactor and CPP acceptance criteria for the downstream chromatography steps.
Canping Jiang, Ph.D., Senior Scientist, Manufacturing Sciences and Technology, Bristol-Myers Squibb
11:45
Case
Study
Developing and Characterizing a High Concentration Ultra-Filtration ProcessStudy
As more products utilize high concentration formulations, the development of UFDF processes become more complicated and challenging. Process complexities combined with meeting product quality requirements, maintaining project timelines, and tailoring the process to fit into multiple manufacturing facilities create additional hurdles. This talk will discuss process development strategies used to develop, characterize, and scale up a high concentration UFDF process to full scale production. In addition, this presentation will include some of processing data collected at small, pilot, and manufacturing scale along with how they compared.
Kelby Lau, Engineer II, Process Development - Late Stage Purification, Genentech, Inc.
12:45
Lunch on Your Own
Recovery & Purification
1:45
Chairperson's Remarks
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
Utilizing Continuous Processing to Decrease Operation Time and Improve Facility Utilization
2:00
Continuous Protein A Chromatography for the Purification of Monoclonal Antibodies Using an Automated Column Switching Approach
We present an automated control strategy for continuous chromatography that permits monitoring of system performance by continuously comparing signals measured throughout the system. This strategy enables the automation of column switching and was tested using both high and low titer harvests. The system has proven to be quite robust and has provided yields and quality that are comparable with batch mode chromatography.
Stephen Lyle, M.S., Principal Research Advisor, Bioprocess Development, Pfizer
We present an automated control strategy for continuous chromatography that permits monitoring of system performance by continuously comparing signals measured throughout the system. This strategy enables the automation of column switching and was tested using both high and low titer harvests. The system has proven to be quite robust and has provided yields and quality that are comparable with batch mode chromatography.
Stephen Lyle, M.S., Principal Research Advisor, Bioprocess Development, Pfizer
2:30
Case
Study
Straight Through Processing (STP) in Monoclonal Antibody PurificationStudy
Straight Through Processing (STP) in downstream purification (DSP) is an evolutionary platform to enable on-demand supply of process buffer prepared in-line, and to automate three purification steps, a DSP1 Chromatography step, a DSP2 Chromatography step, and a Virus Removal Filtration (VF) step into a continuous streamlined single unit of operation. This would shorten the overall operation time, improve facility utilization and throughput, and eliminate certain intermediate hold and in-processing testing requirements for monoclonal antibody manufacturing.
Bin Lin, Ph.D., Principal Research Scientist, Strategic Technology Development, API Large Molecules, Johnson & Johnson Pharmaceutical R&D
3:00
Networking Refreshment Break
Applications of Automated, High-Throughput Technologies in Downstream Processing
3:30
Miniaturization of Chromatography Processes for Use in High Throughput Screening
We have developed purification methods using a 96-well filter plate format to achieve similar yield and product quality to purification using preparative columns. Two chromatography modes were evaluated: protein A affinity and ion exchange chromatography. The development of these robotic methods & their comparison to preparative scale chromatography will be discussed along with the potential applications of these robotic tools.
Maricel G. Rodriguez, Senior Research Associate, Early Stage Purification, Genentech, Inc.
We have developed purification methods using a 96-well filter plate format to achieve similar yield and product quality to purification using preparative columns. Two chromatography modes were evaluated: protein A affinity and ion exchange chromatography. The development of these robotic methods & their comparison to preparative scale chromatography will be discussed along with the potential applications of these robotic tools.
Maricel G. Rodriguez, Senior Research Associate, Early Stage Purification, Genentech, Inc.
4:00
Multi-Modal Ion Exchange Resins - An Explorative Study
Since the development of combinatorial chemistry and ligand libraries significant efforts have been spent screening for affinity mimetics, targeting commercially interesting biomolecules - with limited success. Using HTPD technologies and DoE we have studied ligand density effects on capacity, yield, and removal of critical contaminants. Two different multi-modal ligands, N-benzyl-N-methyl ethanolamine and N-benzoyl-homocysteine, has shown promising results.
Hans J. Johansson, Staff Scientist, R&D, GE Healthcare Bio-Sciences, Sweden
Since the development of combinatorial chemistry and ligand libraries significant efforts have been spent screening for affinity mimetics, targeting commercially interesting biomolecules - with limited success. Using HTPD technologies and DoE we have studied ligand density effects on capacity, yield, and removal of critical contaminants. Two different multi-modal ligands, N-benzyl-N-methyl ethanolamine and N-benzoyl-homocysteine, has shown promising results.
Hans J. Johansson, Staff Scientist, R&D, GE Healthcare Bio-Sciences, Sweden
4:30
High Throughput Screening of Mixed Mode Chromatography Media to Develop a Two-Column Process for Monoclonal Antibody Purification
Multimodal chromatography media have attracted great deal of attention due to their unique selectivity for monoclonal antibody (mAb) purification. The performances of these resins are highly dependent upon processing conditions when used in polishing step. In this work, we applied a high-throughput screening (HTS) approach to quickly evaluate multiple mixed-mode resins in a wide range of operating conditions for flow-through polishing of a mAb molecule. A central composite DOE was run in 96-well plate for these resins, and the key performance parameters were measured and compared with column run data. The best mixed mode resin was selected and further used to develop a two-column purification process, which gives comparable product yield and quality as a standard three-column process.
Chen Wang, Ph.D., Senior Scientist II, Process Sciences, Purification, Abbott Bioresearch Center
Multimodal chromatography media have attracted great deal of attention due to their unique selectivity for monoclonal antibody (mAb) purification. The performances of these resins are highly dependent upon processing conditions when used in polishing step. In this work, we applied a high-throughput screening (HTS) approach to quickly evaluate multiple mixed-mode resins in a wide range of operating conditions for flow-through polishing of a mAb molecule. A central composite DOE was run in 96-well plate for these resins, and the key performance parameters were measured and compared with column run data. The best mixed mode resin was selected and further used to develop a two-column purification process, which gives comparable product yield and quality as a standard three-column process.
Chen Wang, Ph.D., Senior Scientist II, Process Sciences, Purification, Abbott Bioresearch Center
5:00
Close of BioProcess International™ Conference 2010
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