Antibody Development & Production 
Event Information
Document Title
Agenda
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Sponsored Session Tuesday, March 3, 2009 | SPONSORED SESSION | DAY ONE | DAY TWO | DAY THREE | | ||||
| Expertise & Innovation for Your Manufacturing Excellence | ||||
| 1:00 pm - 5:00 pm |
Sponsored by: As part of the Antibody Development & Production conference, we are pleased to bring you a half-day technology session featuring Lonza's top in-house experts with extensive case studies, scientific data, and hands-on experience. In this session, we will address the key technical challenges, important drivers and risk mitigation factors that translate into best practices for Lonza as well as the global biomanufacturing industry. You will also learn how Lonza's latest innovative developments can add high value to continuous process improvements that contribute to time and cost efficiencies.
Join us to learn and discuss various challenges and solutions with Lonza's experienced scientists, including: | |||
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Main Conference - Day One Wednesday, March 4, 2009 | SPONSORED SESSION | DAY ONE | DAY TWO | DAY THREE | | ||||
| 7:00 | Registration and Coffee | |||
| 8:00 | Chairperson's Opening Remarks Abhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences, Bristol-Myers Squibb | |||
| Accelerating Cell Line Development and Controlling Clonal Variability | ||||
| 8:15 | Cell Line Development Timeline Improvements through Technology and Revised Processes The cell line development group was charged with the goal of reducing the time taken to introduce a therapeutic molecule into the clinic. The resulting improvements in the cell line development process generated cell lines with acceptable attributes in approximately half the time. The changes also improved the efficiency of project flow by overlapping the activities of several groups. Nels Pederson, Ph.D., Associate Director, Cellular Engineering, Biogen Idec | |||
| 8:45 | An Integrated Approach to Mammalian Cell Line Development Abstract to come. John Mott, Ph.D., Director, Bioprocess R&D, Cell Line Development, Global Biologics, Pfizer Inc | |||
| 9:15 | BI HEX® - CHO, Concepts & Commitment Biopharmaceutical process development faces at least two challenges: (i) the need to achieve high product titer and (ii) short development times to obtain clinical grade material. Boehringer Ingelheim's CHO high expression BI HEX® cell line generation and process development concept combines many improvements and platform approaches. This yields highly productive clones that grow in serum-free chemically defined media with productivities > 50 pg/cell/d and product titers of > 7g/L in a fed-batch process for mAbs. Torsten W. Schulz, Ph.D., Associate Director, Biopharmaceutical Process Science, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany | |||
| 9:45 | Networking Refreshment Break in Poster and Exhibit Hall | |||
| Concurrent Sessions | ||||
| Accelerating Cell Line Development (continued) | ||||
| 10:30 |
Using FLP/FRT recombination, antibody genes were targeted to an transcriptionally active site in an established antibody production cell line, the resulting recombinant cell lines showed levels of antibody production comparable to the parent cell lines. This system has now been extended to several new high producing NS0 lines. Data on recombination efficiency, comparison of MAb production, growth features in bioreactors and other phenotypes between parental cell lines and their recombinants will be presented. Amit Varma, Ph.D., Director, PDL Biopharma Inc. Audrey Jia, Ph.D., Staff Scientist, PDL BioPharma Inc. | |||
| 11:00 |
The cell line used for protein production typically has the most significant impact on productivity. A carefully designed clone selection process is crucial to achieve high titers and acceptable product quality. To meet requirements for a high demand product a comprehensive cell line selection effort was undertaken. The approach to be discussed includes the use of traditional and high-throughput methods. Kirin Malik Jamison, Senior Engineer, Late Stage Cell Culture, Process Research and Development, Genentech, Inc. | |||
| 11:30 |
The development of cell lines for the manufacturing of therapeutic monoclonal antibodies is a crucial step. It requires a thorough clone selection process in order to identify the best suited clones combining high expression capabilities with superior physicochemical properties of the therapeutic protein. In a case study of a recombinant antibody, we will share insights into potential pitfalls and lessons learned with emphasis on analytics. Jens Lohrmann, Ph.D., Principal Scientist, Novartis Biologics Analytical R&D, Novartis, Switzerland | |||
| Strategic Discussion Group | ||||
| 10:30 | Using Simulating Moving Bed or Other Multi Column Approaches to Increase Downstream Processing Efficiencies, Especially in New High Titer Processes
This panel discussion will focus on the use of Simulated Moving Bed Chromatography SMB Downstream or Multi-Column processing solutions to deal with the increasing pressure on downstream processes to keep pace with upstream process improvements. SMB chromatography has been used for decades as a solution to the ton scale purification problems faced by the food and chemical industries, but issues with aseptic operation and batch control have so far prevented adoption in bioprocess. The primary advantages of SMB are continuous operation and extremely high media and buffer utilization efficiencies.Topics to be discussed include
Panelists: Marc Bisschops, Scientific Director, Tarpon Biosystems Günter Jagschies, Ph.D., Director R&D, Customer Applications, GE Healthcare Bio-Sciences AB, Sweden Natarajan Ramasubramanyan, Ph.D., Group Leader, Polytide Chemistry and Purification Development, Bioprocess R&D, Global Biologics, Pfizer Inc. Sharon Squires, Sales Manager, Business Development, Novasep, Inc. Jörg Thömmes, Associate Director, New Technologies, Biogen IDEC (Invited) Participation is limited to the first 80 attendees on a first come, first served basis. | |||
| 12:00 | Concurrent Technology Workshops | |||
Development of a Downstream Process for Purification of Monoclonal Antibodies at Clinical Scale, A Case Study
This presentation describes the development of a monoclonal antibody (MAb) purification process. Screening of chromatography resins and operating conditions were done in a High Throughput Process Development (HTPD) format followed by optimization and verification in a small scale column format. The purification process was then transferred to a scale suitable for clinical Phase I/II production. At this stage two options were evaluated and compared with respect to performance and economy: a process based on pre-packed, pre-qualified and sanitized columns and a process utilizing conventional chromatography columns.Kjell Eriksson, Ph. D., Senior Scientist, GE Healthcare Bio-Sciences AB, Sweden | ||||
QbD Drives Increased Performance Demands in Production Media
The QbD paradigm is increasing the features demanded in production media and feeds. Therefore they must support 1) understanding the relationship between process inputs and performance through identification of critical raw material attributes, 2) an increased spectrum of material characterization approaches including spectroscopic and sensor technologies, and 3) reduction or accommodation of material variability without compromising product quality.Bill Whitford, Senior Manager, Research and Product Development, Thermo Scientific | ||||
| 12:30 | Networking Luncheon in Poster and Exhibit Hall | |||
| Concurrent Sessions | ||||
| Upstream Process Optimization for Productivity and Product Quality | ||||
| 1:45 | Chairperson's Remarks Nels Pederson, Ph.D., Associate Director, Cellular Engineering, Biogen Idec | |||
| 2:00 | Improving Quality and Incorporating Quality by Design Lilly has established a mammalian cell culture platform to develop therapeutic proteins such as humanized monoclonal antibodies. While platform strategy is applied to early stages of development, significant development efforts are devoted to late stage products to improve productivity, product quality, and manufacturability. Examples of phase appropriate cell culture development incorporating risk assessment and quality by design will be presented. Tongtong Wang, Ph.D., Research Advisor, Group Leader for Mammalian Cell Culture Development, Bioprocess R&D, Eli Lilly & Company | |||
| 2:30 | Impact of Product Quality and Characteristics on the Cell Line Engineering Process for Therapeutic Antibodies Unique physicochemical properties of therapeutic antibodies can impact biopharmaceutical development. Integration of product characteristics and quality considerations into the Cell Line Engineering design helps to mitigate risks and accelerate timelines. Gene and transcript optimisation, adjusted vector design, advanced selection strategies and a combination of manual and automated screening provide the basis for successful isolation of fine-tuned antibody producer clones. Volker Sandig, Ph.D., Vice President, Molecular Biology & Virology, ProBioGen AG, Germany | |||
| Interactive Panel Discussion | ||||
| 1:45 | Can Downstream Processing Keep Pace Economically with Cell Culture? Topics to be discussed include:
Panelists: Jim Davies, Ph.D., Head DSP Process Engineering Group, Lonza Biologics, United Kingdom Abhinav Shukla, Ph.D., Associate Director Manufacturing Sciences, Bristol-Myers Squibb Andrew Sinclair, M.S., Managing Director and Co-Founder, BioPharm Services Ltd, United Kingdom Tim Tressel, Ph.D., Director, Purification Process Development, Amgen Inc. Gary J. Welch, Director, Process Science, Abbott Bioresearch Participation is limited to the first 60 attendees on a first come, first served basis. | |||
| 3:00 | Networking Refreshment Break in Poster and Exhibit Hall | |||
| Keynote Presentations | ||||
| 3:45 | How do We Get to 30 g/L Using Fed-Batch Technology? What Are the Limitations? Production of antibody drugs using mammalian cell culture has made significant progress over the last 20 years. Typical titers are nowadays in the range 2-5 g/L with reports more recently in the 10 g/L range. The presentation will discuss some of the involved limitation around standard fed-batch process realization in typical manufacturing facilities. Using case studies of intensifying fed-batch processes at Biogen Idec limitations to titer and volumetric productivity will be estimated and potential improvement opportunities discussed. Thomas Ryll, Ph.D., Director of Cell Culture Development, Biogen Idec | |||
| 4:15 | Thoughts from the New Kids on the Biotherapeutics Block Dr. Rutter will discuss Pfizer's perspective, as the new kid on the block, of what we have tried to copy and what we have tried to avoid in the biotherapeutics industry. He will discuss his thoughts on the critical attributes and developments that could drive greater market penetration for biotherapeutics in the next 10 years, including his thoughts on what biologics manufacturing and delivery might look like. Rick Rutter, Ph.D., Vice President, Pharmaceutical Sciences, Biologics, Pfizer Inc | |||
| 4:45 | Next Generation Commercial Processes Dramatic advances in cell culture technology have been achieved in recent years by the biopharmaceutical industry, and have altered the landscape, prospects and drivers for the future of biomanufacturing. Even as these improvements are consolidated and harvested into contemporary clinical and commercial processes, a variety of challenges and opportunities remain which will require aggressive innovation and adaptability across many disciplines. Timothy S. Charlebois, Ph.D., Director, Cell & Molecular Sciences, Wyeth BioPharma | |||
| 5:15 | Expanding the Chromatographic Toolbox to Enhance Downstream Processing The drive for higher titre cell culture processes is adding pressure to the chromatographic steps in the downstream process and the development of novel, industry scalable chromatographic products, capable of dealing with these challenges, is ongoing. A new addition to the Chromatographic toolbox will be presented here; one that will enhance process productivity, increase throughput and help reduce processing costs. Peter R. Levison, Ph.D., MBA, Technology Development Director, Pall Life Sciences | |||
| 5:45-7:00 | Networking Cocktail Reception in Poster and Exhibit Hall Co-Sponsored by: 
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Main Conference - Day Two Thursday, March 5, 2009 | SPONSORED SESSION | DAY ONE | DAY TWO | DAY THREE | | ||||
| 7:30 | Coffee | |||
| 8:00 | Chairperson's Opening Remarks Kathie Fritchman, Manager, BioProcess Application - Advanced Bioprocessing, BD Biosciences | |||
| Concurrent Sessions | ||||
| Strategic Approaches for Shortening Development Timelines | ||||
| 8:15 | Development of a Fed-batch Process for GS-CHO Cell Lines GS-CHO cell lines are widely used for the production of monoclonal antibodies. In order to meet the ever increasing demand for higher product concentrations, work was performed to improve Lonza's fed-batch process. This presentation focuses on how improvement to medium and nutrient feed composition, modification of feeding strategy and physicochemical parameters increased product concentration from 3.1 g/L to greater than 5.2 g/L. Martyn Shaw, Principal Scientist, Cell Culture Process Development, Lonza Biopharmaceuticals plc, United Kingdom | |||
| 8:45 | Determination of the Optimal Resin and Operating Parameters for a Cation Exchange Step in a Platform Purification Process The challenge for a platform purification process is to provide maximum purity with the least optimization. Every unit operation must be designed to work for multiple products with the widest operating range. In our platform, the cation exchange chromatography step plays a critical role in removal of host cell protein and aggregate, but lacks throughput due to operational limitations. Using the linear gradient elution model developed by Yamamoto, we determined the optimal operating parameters for multiple resins, and then screened the resins for capacity and selectivity for various antibodies. Judy Glynn, M.S., Senior Principal Scientist, Pfizer Inc | |||
| 9:15 | Process Development Approaches for Shortening Timelines Abstract to come. Scott Gangloff, M.S., Associate Director, Process Engineering, Bristol-Myers Squibb | |||
| Technical Advances in Upstream and Downstream Processing | ||||
| 10:30 | Designing Quality in Biopharmaceuticals: In silico Aggregation Screening and Protein Engineering to Improve Developability and Safety Profiles Protein aggregation and low stability can impose severe restraints in the development of biopharmaceuticals and, potentially, increase the risks of undesired immune responses in patients. In silico predictive methodologies have been used to screen out polypeptides with aggregation and stability issues early on in the development process. Similar approaches have been applied to generating improved biopharmaceuticals through protein engineering. Jesús Zurdo, Ph.D., Head of Research, Advanced Protein Technologies, Lonza Biologics plc, United Kingdom | |||
| 11:00 | Antibody Production Using Smart Disposable Systems In order to have a truly disposable process, reactor technology needs to reach a point where they can perform like conventional reactors. For this to happen, sensor technology needs to be disposable. We will present examples of the successful use of disposable technology for monitoring and controlling pH and oxygen in a variety of bioreactor systems at different scales. This approach has the potential to integrate processes all the way from late stage screening to manufacturing. Govind Rao, Ph.D., Professor and Chair, Chemical and Biochemical Engineering, Center for Advanced Sensor Technology, University of Maryland Baltimore County | |||
| 11:30 | Miniaturization and Automation of a Complete Chromatographic Process for the Purification of MAb Modern high throughput platforms allow the miniaturisation and automation of chromatographic procedures, both in batch and packed column format. The latter can be used to investigate not only a single chromatographic procedure but allows the synthesis of a complete chromatographic process. With such a tool in hand, issues arising in process development can be answered with a limited amount of feedstock and manpower. The realization of this concept will be shown on a typical mAb purification process. Jürgen Hubbuch, Ph.D., Professor, Biomolecular Separation Processes, Institute of Engineering in Life Sciences, University of Karlsruhe, Germany | |||
| Special Strategy Discussion Forum | ||||
| 8:00 | Part One: Protein A Capture - Perception and Reality Almost all monoclonal antibodies currently on the market and in clinical trials are produced with Protein A resins in the capture step with either one or two polishing steps following. Still the step is debated as too expensive. Other issues held against it include stability to CIP regimes and ligand leakage. The panel discussion shall allow the arguments pro and contra to be heard and discussed. A differentiated picture of advantages and disadvantages, costs and benefits, opportunities and limitations shall be created. Moderator: Peter Latham, President, BioPharm Services US Panelists: Jonathan Romero, Ph.D., Senior Engineer III, Biopharmaceutical Development, BioGen Idec Sanchayita Ghose, Ph.D., Manager, Process Sciences Downstream, Bristol-Myers Squibb (Invited) Günter Jagschies, Ph.D., Director R&D, Customer Applications, GE Healthcare Bio-Sciences AB, Sweden Thomas Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. Ganesh Vedantham, Ph.D., Director, Purification Process Development, Amgen Inc. (Invited) Participation is limited to the first 60 attendees for each part of the discussion on a first come, first served basis. | |||
| 10:30 | Part Two: Alternative Purification Methods - Promise or Over-Promise? In search of efficient low-cost downstream processing methods, the term "anything but chromatography" (ABC) has been phrased. Precipitation, extraction, and membrane separation methods, both standard and modified through selectivity and / or productivity enhancing improvements have been investigated. The panel discussion shall shed light on where we really are with these approaches. Moderator: Peter Latham, President, BioPharm Services US Panelists: Pete Gagnon, Ph.D., Chief Scientific Officer, Validated Biosystems Judy Glynn, M.S., Senior Principal Scientist, Pfizer Inc. Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen Inc. Jörg Thömmes, Ph.D., Associate Director, New Technologies, Biogen Idec (Invited) James Van Alstine, Ph.D., Professor, Staff Scientist, Protein Separations, GE Healthcare, Sweden Rob van Reis, Distinguished Engineer, Late Stage Purification, Genentech, Inc. Participation is limited to the first 60 attendees for each part of the discussion on a first come, first served basis. | |||
| 12:00 | Technology Workshops | |||
Process Development, Characterization, Large Scale Production, and Quality Control of Follow-on Biologics
We will discuss the key steps in - i) developing processes for large scale manufacturing of follow-on biologics, ii) characterizing products, and iii) monitoring product similarity. Following product quality attributes will be discussed - aggregation, charge heterogeneity, glycosylation, and bioactivity. Clone specific impact of media, feed, temperature, pH, sodium butyrate etc. on titer and product quality will be discussed.Sigma Mostafa, Ph.D., Senior Scientist, Cell Culture Process Development, Diosynth Biotechnology | ||||
Ceramic Hydroxyapatite: A Powerful Polishing Chromatographic Media for Monoclonal Antibody Production
Ceramic Hydroxyapatite has emerged as a platform technology for the polishing of monoclonal antibodies. CHT™ Ceramic Hydroxyapatite provides orders of magnitude clearance for host cell proteins, viruses, DNA and leached protein A. This workshop will present data from several monoclonal antibody purifications and discuss one of the most powerful aspects of CHT, the ability to remove aggregates.Xuemei He, Ph.D., Staff Scientist, Process Chromatography Division, Bio-Rad Laboratories | ||||
| 12:30 | Networking Luncheon in the Poster and Exhibit Hall | |||
| Concurrent Sessions | ||||
| Approaches to Improve and Control Process and Product Quality | ||||
| 1:40 | Chairperson's Remarks Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen Inc. | |||
| 1:45 |
Identification of critical quality attributes is essential for the implementation of suitable testing plans and process controls for biopharmaceutical products. This presentation will go over a rationale for determining critical quality attributes during product development. The focus will be on how non-clinical and clinical experience may be used to determine the likelihood of occurrence and extent of an impact on either efficacy or safety. Case studies will be presented for the criticality determination of several product variants. Ziping Wei, Ph.D., Scientific Director, Analytical Biochemistry, MedImmune | |||
| 2:15 | Quality by Design for Bionalytical Methods Quality by Design (QbD) is an area of significant industrial and regulatory activity and interest. It's main focus is the manufacturing process. This presentation discusses strategies for the possible usage of qbd for the validation of bio-analytical methods. It also addresses the advantages and challenges this approach is providing to the field of bio-analytics and how it might complement and enhance qbd efforts for manufacturing processes. Dieter Schmalzing, Ph.D., Director, MMTech, CQPS, Genentech, Inc. | |||
| 2:45 |
For characterization of unit operations, a qualified small scale model is used to mimic the large scale process. For harvest unit operations, however, this is challenging due to the difficulty with qualifying predictable small scale models. Hence most of the characterization studies are performed either at pilot scale or at commercial scale. A stepwise approach was taken to prioritize operational parameters for evaluation. In this case study the approach to identify operational parameters, scope, rationale and results from the harvest characterization of a monoclonal antibody are presented. Vinod Bulusu, M.S., Engineer, Global Process Engineering, Amgen Inc. | |||
| Interactive Workshop and Discussion | ||||
| 1:45 | Genomics, Proteomics, and Metabolomics: Applications to Antibody Production Recent years have seen a rise in the use of a variety of 'omics technologies in the arena of biopharmaceutical process development. These types of technologies are extraordinarily powerful, and can produce a wealth of data and potential insights. Now that the tools are becoming more accessible, the challenge has become using them wisely and effectively. This workshop is intended to be an active discussion by any and all attendees in sharing opinions, challenges, and experiences with the current state of technology, and the promise of the future. A major challenge in any 'omics approach is taking the learnings and reducing them to practice. Under this broad heading, the following topics will be discussed:
Mark W. Melville, Ph.D., Principal Research Scientist I, Cell & Molecular Sciences, Wyeth BioPharma Dana Di Nino, Ph.D., Senior Research Scientist II, Cell & Molecular Sciences, Wyeth BioPharma Participation is limited to the first 60 attendees on a first come, first served basis. | |||
| 3:15 | Networking Refreshment Break and Last Chance for Poster and Exhibit Hall Viewing | |||
| Regulatory Considerations and Strategies for Comparability: Pre- & Post-Approval | ||||
| 4:00 | Comparability during Clinical Development Although comparability tends to focus on post-approval changes, there is a need to assure appropriate product quality throughout clinical development. A program of predefined comparability assessments should link product quality from preclinical safety studies to FIH clinical trials then to Phase II and pivotal trials. As a product moves through development, the regulatory expectations for the nature and extent of comparability studies increases. Multiple considerations are required to design the appropriate studies and both product and process comparability need to be considered. Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen Inc. | |||
| 4:30 |
Over the course of a product life cycle, modifications to the manufacturing process are almost inevitable. Process changes can be particularly challenging for biologics which are inherently complex and demonstrate varying degrees of heterogeneity. For these reasons, understanding the potential impact of a process change on product quality is essential and requires robust analytical tools capable of detecting subtle changes to the product profile. Using a case study we will describe some of the challenges and suggest strategies to minimize risk while maximizing product and process knowledge. Asenath M. Rasmussen, Research Fellow, Analytical Research & Development, Worldwide Pharmaceutical Sciences, Pfizer Inc | |||
| 5:00 | Regulatory Considerations in Performing Post-Approval Comparability Studies for Biotechnology Products: An Industry Perspective Comparability is an integral part of lifecycle management. A comparability exercise typically supports a change to the manufacturing process and evaluates the pre-and post-change products with the goal of demonstrating high similarity. Given the complex nature of proteins, the challenges and approaches in demonstrating their comparability can vary. In this presentation, key strategic approaches in supporting comparability will be discussed. Ron Taticek, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc. | |||
| 5:30 | In-House Data Supporting Modular Viral Validation for Low pH and Q Sepharose Fast Flow (QSFF) Chromatography FDA PTC and the new EMEA guideline on virus safety of biotech products used in clinical trials allow a modular viral validation or a reduced viral validation of materials for clinical studies when specific requirements are met. Genentech's in-house data demonstrates that low pH and QSFF chromatography unit operations are two robust viral inactivation/removal steps. Application of prior in-house data of these two unit operations to new products in clinical development will be discussed Lenore Norling, Manager, Process Research & Development, Genentech, Inc. Bin Yang, Ph.D., Scientist, Process Research & Development, Genentech, Inc. | |||
| 6:00 | Close of Day Two | |||
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Main Conference - Day Three Friday, March 6, 2009 | SPONSORED SESSION | DAY ONE | DAY TWO | DAY THREE | | ||||
| 8:00 | Chairperson's Opening Remarks Patricia Rancatore, Ph.D., Scientist, Early Stage Purification, Genentech, Inc. | |||
| Effective Strategies to Overcome Manufacturing Challenges | ||||
| Featured Presentation | ||||
| 8:15 | A Paradigm Shift in Cell-Culture Based Biomanufacturing Processes This presentation will focus on a historical overview of successful biomanufacturing using cell culture technology, today's state-of-the-art biomanufacturing technology, and refer to the paradigm shift in process development and manufacturing we've seen during the past years. Dr. Noe will inform viewers of some novel technologies in the biomanufacturing arena as well. Wolfgang Noe, Ph.D., Vice President, Biopharmaceutical Development, Biogen Idec | |||
| 8:45 | Antibody Degradation in a CHO Production Process During scale-up of a monoclonal antibody process, we observed degradation of the antibody candidate during harvest and primary recovery operations. Subsequent laboratory studies demonstrated that cells subjected to mechanical shear during harvest operations released cellular factors that contributed to this antibody degradation phenomenon. Several methods were tested to prevent this antibody degradation and will be discussed here. Melody Trexler Schmidt, Ph.D., Scientist, Late Stage Purification, Genentech, Inc. | |||
| 9:15 | Overcoming Challenges in Multi-Product Biopharmaceutical Manufacturing The foreseeable future of biopharmaceutical manufacturing will require the production of multiple products in a single facility, each with relatively smaller volumes than previous products. One of the manufacturing and economic challenges will be the implementation of rapid and effective product-to-product change-over strategies that meet regulatory requirements and are backed up by quantitative data on cleaning effectiveness and potential carryover from the previous product. Management of changeover down-time, materials management issues, quality documentation and customer expectations are all integral to achieving maximum total annual output from contract manufacturing facilities. Donald F. Gerson, Ph.D., President, Celltrion, Inc., Korea | |||
| 9:45 | Networking Refreshment Break | |||
| Concurrent Sessions | ||||
| How to Increase Productivity of Downstream Processing | ||||
| 10:15 |
Abstract to come. Natraj Ram, Ph.D., Associate Research Fellow, Global Research and Development and Group Leader, Downstream Bioprocess R&D, Global Biologics, Pfizer Inc | |||
| 10:45 | Direct Capture of MAbs as an Alternative to Clarification and Purification for Single-Campaign Operations This presentation discusses the application of newly developed, single-use adsorption systems that capture monoclonal antibodies directly from the bioreactor, without any clarification steps. A comparison was made between this direct loading onto a mixed mode capture ligand and processing on a protein A packed bed adsorbent. Close similarity of host cell protein levels illustrates the effectiveness of the clarification during capture. Rob Noel, Ph.D., Business Development Manager, Upfront Chromatography | |||
| 11:15 | Polyethylene Glycol Enhanced Binding of Recombinant Proteins in Isocratic Anion-Exchange Chromatography This presentation evaluates the effects of PEG on the isocratic anion-exchange chromatography of several recombinant proteins. High throughput batch-binding and corresponding packed column experiments were employed to probe how PEG alters the adsorption behavior of the products (monomer) and multiple product-related high molecular weight (HMW) species to the resin. The observed phenomena were demonstrated to be useful in isocratic chromatographic processes in certain scenarios. Practical considerations inherent in incorporating PEG into downstream processing will also be discussed. Aaron Noyes, M.E., Process Engineer, Purification Process Development, Wyeth Biotech | |||
| Interactive Panel Discussion - Advances in Media Development | ||||
| 10:15 | Part One: Chemically Defined vs. Non-Defined Additives There has been a strong drive to develop serum-free formulations that are animal component-free and are tailored to the needs of specific producer cell lines. However such formulations are not always chemically-defined. The use of chemical-defined raw materials ensures the consistency of a media formulation between batches, but considerable developmental research is required to ensure high performance of the desirable combination: chemically-defined and animal-component free. Topics to be discussed include:
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| 11:00 | Part Two: Hydrolysates and Lot-to-Lot Variability Peptide hydrolysates contain a mixture of components of undefined chemical characteristics that have been found to be bioactive. These may include growth promoting or product-enhancing activities. However, batch to batch variation in the composition of the hydrolysates may result in a variable balance between the desirable and undesirable biological properties in culture bioprocesses. This lot-to-lot variability is a potential problem for bioprocesses designed for high-value products such as biopharmaceuticals. Topics to be discussed include:
Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba, Canada Matt Caple, Director of Research and Development, Cell Sciences and Development, SAFC Biosciences Panelists: Bryan Monroe, Ph.D., Process Science Fellow, Process Sciences, Invitrogen Corporation John Birch, Ph.D., Chief Scientific Officer, Lonza Biologics Plc, United Kingdom Iman Famili, Ph.D., Director of Research and Development, GT Life Sciences, Inc. Tom Fletcher, Scientist, R&D, BD Advanced Bioprocessing Zheng Jian Li, Bristol-Myers Squibb (Invited) Geoffrey Francis, Chief Scientist, Novozymes Biopharma AU Ltd, Australia Participation is limited to the first 80 attendees for each part of the discussion on a first come, first served basis. | |||
| 11:45 | Technology Workshops | |||
Initial Recovery Processes using Multilayer Depth Filtration
Increasing high product titers in the production of recombinant proteins and monoclonal antibodies are usually associated with higher cell densities and lower cell viabilities. Cellulose based filtration techniques have been used for the initial recovery from early on but are now challenged with feed streams containing a significant amount of DNA, Chinese hamster ovary protein (CHOP) and other contaminants. This presentation will touch on new considerations when using depth filters in the initial recovery step and present a new fully disposable multilayer filtration concept.Anika Meyer, Process Development Specialist, Sartorius Stedim North America, Inc. | ||||
POROS® Chromatography Media: A Tool for High-Performance Downstream Purification Solutions
The features and benefits of POROS® chromatography media as they relate to improving downstream purification process performance and productivity will be discussed. Performance benchmarking of POROS media will be highlighted. Applications data and process productivity modeling will be used to demonstrate the benefits of utilizing POROS media for purification unit operations.Christine Gebski, M.S., Applications Manager, Process Separations, Applied Biosystems | ||||
| Luncheon Presentation | ||||
| 12:15 | A Practical Approach to Enhanced Process Economics
A major challenge facing the Biopharmaceutical industry today is the need to develop processes in shorter timeframes and at reduced overall costs. The use of novel membrane and filtration technologies can enhance overall process economics, and this presentation will explore the practical use of such products to improve process times, throughput, efficiency and cost. Jon Petrone, Global Technical Director, Technical Support Group, Pall Life Sciences | |||
| 1:45 | Chairperson's Remarks Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany | |||
| Alternatives to Column Chromatography and Protein A | ||||
| 2:00 |
Monoclonal antibodies and Fc fusion proteins are being produced in cell culture in ever increasing quantities with increased product-related impurities. A low cost, nontraditional chromatography resin was successfully developed for the capture of these proteins at loading capacities comparable to Protein A resins. Optimization of wash and elution steps with mobile phase modifiers were able to substantially remove product-related impurities while maintaining high purity and yield. Robert S. Gronke, Ph.D., Principal Scientist, Biogen Idec | |||
| 2:30 |
Recent advances in cell culture productivity create new opportunities for the manufacturing of biologics. They include the use of smaller facilities, single use technologies, faster development times and ultimately lower capital investment (CAPEX) and cost of goods (COG). Increases in cell culture productivity can also generate challenges to the clarification and purification process because of higher cell densities and amounts of impurities. This work will describe innovative ways that address some of the challenges while using the PER.C6® human cell line. Gregory Zarbis-Papastoitsis, Ph.D., Director, Downstream Development, Percivia, LLC | |||
| 3:00 | Networking Refreshment Break | |||
| 3:30 | Extending the Efficiency of Cation Exchange Bioseparations by Host Cell Protein Exclusion Strategy to Design Cost-Effective Manufacturing Processes Platform development enabled more predictable feed streams with comparable process contaminants profiles for a given expression and production system. A close study of the behavioral pattern of these host cell contaminants provides insights to streamline the process conditions leading to highest purity. This is especially true when extending the efficiency of cation exchange column as a capture step to successfully replace more expensive affinity chromatography. HCP removal by cation exchange separation can be extended to 3 to 4 logs thus yielding antibody preparations containing <100ng/mg HCP by a single column. Entire purification process scheme can be simplified by adding a flow-through membrane chromatography. Alahari Arunakumari, Senior Director, Process Development, Medarex | |||
| 4:00 | Using Competitive Adsorption Ion Exchange Membrane Chromatography to Purify Monoclonal Antibodies Ion exchange membranes were used to remove CHO host cell proteins (CHOP). At the conditions tested, both antibody and CHOP species can competitively adsorb to the membrane, allowing the species with the greatest affinity for the membrane (CHOP) to displace the other species (antibody). The technique is both fast and high yielding and uniquely advantageous to membranes. Jerome Bill Jr., Engineer I, Late Stage Purification, Genentech, Inc. | |||
| 4:30 | Designing Viral Clearance Strategies for HuMab Non-Protein A Processes Unlike affinity capture, non-protein A schemes face the viral reduction challenges not only due to the cation exchange capture but also the shortened process steps. Designing effective viral clearance strategies can help choose the leanest and most efficient process scheme. Viral clearance data from multiple HuMab processes (> 10) for each chromatography operation can be used as the building blocks for different process schemes. Furthermore, we are exploring the potential utilization of the collected information for modular approach for future early clinical stage processes. Jue (Michelle) Wang, Ph.D., Assistant Director, Purification Process Development, Medarex, Inc. | |||
| 5:00 | Close of Conference | |||
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