Single-Use Applications for Biopharmaceutical Manufacturing
Event Information
Document Title
Agenda
| Pre-Conference Workshop Monday, June 2, 2008 | DAY ONE | DAY TWO | DAY THREE | | ||||
| 7:30 | Morning Coffee and Registration | |||
| Disposing of Single-Use Systems: A Comprehensive Review of Strategies & Best Practices | ||||
| 8:30 | Chairperson's Remarks & Workshop Overview Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Director and Chair, Technology Committee, Bio-Process Systems Alliance | |||
| 8:45 | Disposal of Disposables – An Examination of Alternatives Increasing employment of single-use systems in biopharmaceutical manufacturing increases the amount of solid waste generated by these processes. This presentation offers the results of a review of current practices in the industry by the Bioprocess Systems Alliance (BPSA) along with their plans for future activities. John Boehm, Business Manager, Bioprocessing Unit, Colder Products Company | |||
| 9:15 | The Environmental Dilemma of Single-Use Manufacturing Although this new direction in biologics manufacturing has created concerns over environmental impacts (e.g., solid waste) compared to traditional stainless steel systems, this presentation will provide an objective and quantitative review of the real costs--and benefits--of single-use. A case study of two sites will compare environmental aspects and impacts of each process, and provide direction on how to weigh the costs vs. benefits. David Newman, MPH, MES, Director Sustainability, Millipore Corporation | |||
| 9:45 | Networking Refreshment Break | |||
| Featured Presentation | ||||
| 10:15 | Analyzing the Carbon Footprint Left by a Company's Use of Disposables On the surface it seems that disposables might have the carbon footprint of Bigfoot. However, disposables may in fact be the Cinderella story where that tiny glass slipper may in fact fit. This presentation will provide the cradle to grave comparison of the total carbon, water, and land footprint of single-use versus permanent facilities. Lindsay Leveen, Associate Director Strategic Planning and Lytics CMC Team Lead, Genentech, Inc. | |||
| 11:00 | Workshop Question & Answer Panel Discussion - Ask the Experts & Share your Thoughts Moderator: John Boehm, Business Manager, Bioprocessing Unit, Colder Products Company Panelists: Lindsay Leveen, Associate Director Strategic Planning and Lytics CMC Team Lead, Genentech, Inc. Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Director and Chair, Technology Committee, Bio-Process Systems Alliance | |||
| 11:45 | Close of Workshop | |||
| Main Conference - Day One Monday, June 2, 2008 | PRE-CONFERENCE WORKSHOP | DAY TWO | DAY THREE | | ||||
| 11:00 | Registration | |||
| Technology Workshop and Luncheon | ||||
| 12:30 |  Determination of Extractables/Leachables from Single Use SystemsSingle-use system materials can introduce compounds that may migrate to finished products. Availability of supplier-generated data on extractables/leachables can be a significant savings in time, labor and cost for users. We will present a systematic approach to study of extractables/leachables into model solvents via novel concepts, practical design, and analytical detection using advanced techniques. Christopher Mach, Marketing Manager for Allegro Single Use Systems, Pall Life Sciences | |||
| 1:15 | Grand Opening of 2008 Exhibit Hall and Poster Viewing | |||
| Assessing the Current Industry Landscape with an Eye on the Future | ||||
| 1:45 | Chairperson's Remarks Adam Goldstein, Senior Manager, Oceanside Clinical Operations, Genentech, Inc. | |||
| Keynote Presentation | ||||
| 2:00 | Single-Use Systems: A Strategic Look Ahead The phenomenal growth of single-use systems and their increasing acceptance in the biopharmaceutical industry raises the question, "What is next?" Key insights on the future direction of the industry will be presented. The insights are based on current technology needs, quality/regulatory initiatives, and the historic basis for the single-use industry's growth. Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare | |||
| 2:45 | Towards Simple Modular Facilities - The Impact of Single-Use Technologies Single-use technologies have revolutionised our approach to design over the past ten years. This presentation will illustrate their impact on facility design and project implementation. These technologies have impacted facility complexity and moved parts of the design implementation from the engineers to the supplier companies. The change of thinking required to maximise the benefits of single-use technologies will be illustrated through recent case studies. Andrew Sinclair, Managing Director, BioPharm Services, United Kingdom | |||
| Technology Workshop | ||||
| 3:15 | Characterization of Single-Use Mixers: Mobius® MIX Disposable Mixing Systems In this workshop, the presenters share case study results, using Mobius single-use mixing systems for liquid-liquid and solid-liquid applications. They will present mixing data for a wide range of media and buffer solutions, including LucraTone™, maltose, phosphate buffered saline, surfactants, and commonly used cleaning/sanitizing agents. The use of computational fluid dynamic (CFD) modeling as a tool for mixing characterization will also be discussed.Sue Walker, Process Engineering, Bioprocess R&D, Millipore Corporation Mani Krishnan, Director, Process Systems, Millipore Corporation | |||
| 3:45 | Networking Refreshment Break with Exhibit and Poster Viewing | |||
| 4:15 | Operational Considerations for Robust Single-Use Systems When faced with the decision to use stainless steel, single-use products or both, initial equipment design and validation are often given higher significance than other operational requirements for implementation. Ancillary equipment, manpower, material management, and other supporting services are crucial for operating single-use systems routinely and reliably. The requirements presented are based on the experiences at a major pharmaceutical company that is considered a pioneer user of single-use systems. Wooiliam Beh, Project Engineer, Crumbs Engineering, Inc. | |||
| 4:45 | Trends in Use of Disposables: Results from 5th Annual Report and Survey on Biomanufacturing Our annual international biomanufacturing industry study surveyed 434 worldwide biomanufacturers & CMOs. We cover annual trends in most all biomanufacturing, including: types of single-use systems currently used; reasons for increased usage; current budgets for disposables, and future increases; factors restricting disposables usage; newly introduced areas of disposables usage; downstream disposable operations; leachables and extractables testing; disposable production scale; vendor satisfaction, and more. Eric S. Langer, Managing Partner, Bioplan Associates, Inc. | |||
| 5:15 | Networking Reception with Exhibit and Poster Viewing | |||
| 7:00 | End of Day One | |||
| Main Conference - Day Two Tuesday, June 3, 2008 | PRE-CONFERENCE WORKSHOP | DAY ONE | DAY THREE | | ||||
| 7:30 | Networking Coffee | |||
| Chairperson Russell Wong, Ph.D., Senior Engineer, Manufacturing Sciences, Bayer Healthcare | ||||
| 8:00 |
Development and Implementation of Tubing Welder Technology at Bayer Tubing welder technology has led to a reduction in risk for microbial contamination when making aseptic tubing connections and has increased operator efficiency for in-process sampling and making aseptic tubing connections. Key project elements for implementing a robust, automated technology will be presented. The presentation will be based on project experiences of supplier and client working collaboratively to continuously improve tubing welder technology. Presenter: Edward Cheng, Senior Project Manager, Manufacturing Sciences, Bayer Healthcare Follow-up Discussion Panelists: Eric Cruz, Senior Validation Specialist, Bayer Healthcare Russell Wong, Ph.D., Senior Engineer, Manufacturing Sciences, Bayer Healthcare | |||
| The Latest Downstream Advancements and the Impact on Production and Economics | ||||
| 8:45 |
A comprehensive analysis supporting a "Total Cost of Ownership" model was developed to advance the understanding of cost-based improvements in the downstream purification of biologics. Both quantitative and qualitative factors have been included in the analysis to confirm or challenge findings arising from the model which is specifically related to the incorporation of advanced disposable membrane technologies in manufacturing operations. Rob Gustines, Founding Partner, Ampfuul LLC | |||
| Technology Workshop | ||||
| 9:15 |  Single-Use Bioreactor OptimizationRapid, cost-efficient scale up, biological manufacturing and change-over are possible with today's disposable technologies. The HyClone Single-Use Bioreactor (S.U.B.) provides these advantages using the industry-standard stirred-tank design. This system has been well-proven for a broad range of applications at scales of 25 to 1000L. A technical overview of the S.U.B., including available systems, cell platforms, process parameters, mixing and sparging options, monitoring and control options, as well as application data will be presented. Cory Card, Senior Technical Services Manager, Thermo Fisher Scientific | |||
| 9:45 | Networking Refreshment Break with Exhibit and Poster Viewing | |||
| 10:15 |
This presentation discusses downstream processing advances for inter-connectivity, leak testing, extractables from process-wetted materials, and disposable options for solids-liquid handling. Solid-liquid separation either for perfusion or for cell harvesting presents challenges to disposables. Few disposables centrifugation options exist for biopharm processing. We highlight an existing disposable single-use solution for centrifugation, with specific applicability to harvesting viable mammalian and insect cells under containment. Geoff Purdom, Process Development Consultant, IMPACT Technology Consultants | |||
| 10:45 |
BioSMB™ enhances traditional SMB through the use of easy to use, disposable components including a novel valve cassette/ array design and disposable-format chromatographic columns to provide a fully disposable solution for biotherapeutic purification. Data acquired running a scaled-down MAb process will be presented and a fully disposable bioprocess train for clinical manufacturing will be discussed and modeled. Marc Bisschops, Scientific Director, Tarpon Biosystems | |||
| 11:15 |
Co-authored with Bryan Pingitor, Senior Process Engineer, Bristol-Myers Squibb Company, this presentation analyzes how a single-use fluid path can be maintained using non-product contact pinch valves, a single-use bubble trap design, a novel single-use pump, and single-use sensors. Key requirements, such as not sacrificing performance, will be reviewed and data will compare pilot plant runs for a MAb purification process from the standard system to runs on the single-use system. Jim Furey, General Manager, PendoTECH | |||
| 11:45 | Networking Luncheon with Exhibit and Poster Viewing | |||
| Evaluating Single-Use Bioreactors and Sensors: Factors to Consider | ||||
| 12:55 | Chairperson's Remarks Michael Brandenstein, Scientist, Cell Science and Technology, Amgen Inc. | |||
| 1:00 |
Hear a discussion in different approaches on adopting disposable bioreactors at Lilly. Two case studies using Wave and Hyclone SUBs will be presented. Advanced bioreactor operation methods such as in-tank scale-up and rolling seed, greatly facilitated by the disposable bioreactors, will be discussed. Brian Finch, Process Engineer, Fermentation Development, Eli Lilly & Co. | |||
| 1:30 |
This presentation will describe a three-month direct head-to-head comparison of a pilot scale disposable bioreactor compared to a similar scale traditional stainless steel reactor for the production of a recombinant protein. We will describe the drivers, including technical, operational and financial, that make single-use reactor technology a viable option for pilot scale through commercial scale production of recombinant proteins. Amy Troncoso, Senior Supervisor, Pilot Cell Culture Group, Wyeth Biopharma | |||
| 2:00 |
In the recent development of a monoclonal antibody process, a disposable culture bag unit operation was developed for the inoculum train. Before transferring the process to the clinical manufacturing site, the robustness of the culture bag unit operation was studied. This presentation provides the rationale behind the design and the analysis of the robustness studies and includes proposed improvement to future robustness studies. Michael Brandenstein, Scientist, Cell Science & Technology, Amgen Inc. | |||
| 2:30 | Networking Refreshment Break and Last Chance for Exhibit and Poster Viewing | |||
| 3:00 |
We assessed the disposable 2-L Biostat® CultiBag bioreactor (Sartorius) that utilizes rocking motion for mixing and gas transfer. A parallel comparison of the CultiBag was done to conventional stirred-tank bioreactors as well as disposable WAVE® bioreactors (Wave Biotech). The CultiBag was evaluated with respect to its operability, cell culture performance, control dynamics, and ease of use. Amardeep Singh Bhalla, Ph.D, Senior Scientist, Schering-Plough Corporation | |||
| 3:30 |
From vial thaw to clarified harvest, the use of disposable systems has enabled Shire HGT to harness the many benefits of disposables in our perfusion process. I will discuss the utility of the Xcellerex XDR bioreactor coupled with the Centritech's Lab III centrifuge to form a pilot scale disposable system. Lessons learned and product improvements will be discussed along with a close look at integration of these systems into a small foot print with limited utilities requirements. Chris Adams, Manager of Bioreactor Operations, Shire HGT | |||
| 4:00 | Evaluating Probes and Sensors for Use in Single-Use Systems The phenomenal growth of single-use systems in bioprocessing has been a result of both the need for and the development of appropriate probes and sensors for those disposable or single-use systems. This presentation will discuss the latest probes and sensors available for end-user implementation and compare and contrast their performance relative to traditional instrumentation. Kim L. Nelson, Ph.D., Senior Associate and Director, Biopharmaceutical Services, CRB Consulting Engineers | |||
| 2008 Technology Idol: Technology Updates and Discussion | ||||
| 4:30 | Moderator's Opening Remarks Based on the popular television program, this session presents the latest technologies from manufacturers of single-use equipment or systems including application data if available. After each ten-minute presentation, the panel of end-users will question the developers for fine minutes about application concerns. Moderator: Russell Wong, Ph.D., Senior Engineer, Manufacturing Sciences, Bayer Healthcare Panelists: Michael Brandenstein, Scientist, Cell Science & Technology, Amgen Inc. Adam Goldstein, Senior Manager, Oceanside Clinical Operations, Genentech, Inc. | |||
| 4:35 | A Comprehensive Approach to Mixing in Single-Use Bags LevTech offers disposable mixing systems designed for the broadest range of bioprocess applications from 5 - 5,000L. LevTech mixing systems are cost effective, portable, and designed so that one Drive Unit may service multiple mixing bag configurations or volumes. Alexandre Terentiev, Ph.D., Chief Technology Officer, LevTech, Inc. | |||
| 4:50 | Using a New Scalable, Single-Use, Disposable Bioreactor System for Growing Cell Cultures Several formats of disposable bioreactors are available for commercial use and are primarily used for the growth of suspended cell cultures. A trans-Atlantic collaboration between ATMI, Artelis, DCI-Biolafitte and Pierre Guerin has developed a fully scalable, single-use bioreactor, based on existing commercially proven disposable mixing technology, that has been shown to successfully culture both suspended and microcarrier anchored cells, producing high yields, reproducible results under ultra-low shear conditions. The results of these experiments will be presented and discussed. Roman Rodriguez, Global Product Manager, ATMI Life Sciences | |||
| 5:05 | New Developments in Single-Use Technology Mr. Sciamanna will present Gore's latest innovation in single-use technology: an easy to use, sterile system that allows secure monitoring of cell growth and development in high-value biotherapeutic products. Dom Sciamanna, Product Specialist, Gore™ PharmBIO Products | |||
| 5:20 | A New Approach to Conventional Freezing: Celsius FFT Sartorius Stedim Biotech developed a new economic freezing solution named Celsius FFT which allows freezing biopharmaceuticals within standard freezers using a sterile, single-use disposable container that will safeguard product integrity. Gaël Péron, Product Manager - Freeze-Thaw Systems, Sartorius Stedim Biotech | |||
| 5:35 | End of Day Two | |||
| Main Conference - Day Three Wednesday, June 4, 2008 | PRE-CONFERENCE WORKSHOP | DAY ONE | DAY TWO | | ||||
| 7:30 | Networking Coffee | |||
| Single-Use Manufacturing: The Economics, the Risks and the Quality | ||||
| 8:15 | Chairperson's Opening Remarks Jonathan Morse, Principal Consultant, The Compliance Associates, LLC | |||
| 8:30 | Evaluating Disposable Options with Process Modeling and Simulation Hear an example of using the process modeling and simulation as a tool to evaluate disposable and non-disposable design options. Learn how these design options are examined and compared based on their operation costs, labor demand, cycle time, process throughput, and requirement for utility predicted by the model. Lilong Huang, Ph.D., Technology Specialist, Bayer Corporate & Business Services Mike Su, Ph.D., Technology Specialist, Bayer Corporate & Business Services | |||
| 9:00 | A Prospective Risk Assessment Methodology for Leachables and Extractables Due to the explosion of single-use components used in the manufacture of biopharmaceuticals, a method for evaluating the risk from leachable and extractables released into the process stream was developed. This systematic methodology utilizes a team based approach coupled with multiple levels of triage to ensure that highest levels of scrutiny are given to the riskiest components. Scott E. Haller, Supervisor, Process & Analytical Sciences, Regeneron Pharmaceuticals | |||
| Technology Workshop | ||||
| 9:30 |  Advances in Single Use Capture ChromatographyDisposable buffer bags, tubing, aseptic connectors, and viral clearance filters have demonstrated their value vs. conventional technologies by reducing risk of batch-to-batch contamination. Nysa has developed a membrane-based single-use capture chromatography technology to provide users with further options for their single-use systems. Applications for single-use capture chromatography technology will be presented, focusing on the interplay between applications, product format and membrane chemistries. Chris Shields, Director of Marketing, Nysa Membrane Technologies, Inc | |||
| 10:00 | Networking Refreshment Break | |||
| Featured Presentation | ||||
| 10:30 | Successfully Working in Tandem with your QA Department Improved confidence in single-use applications, along with significantly lower operation costs is driving biopharmaceutical process managers/engineers to implement disposable assemblies. However, the presence of extractables in biotech products is still a concern. Partnering with Quality to determine the use points for disposables and what tests should be performed is an important part of the planning phase of the implementation process. Adam Goldstein, Senior Manager, Oceanside Clinical Operations, Genentech, Inc. | |||
| 11:00 | BPSA Technical Guides for Application of Single-Use Disposable Systems in Biopharmaceutical Manufacturing Suppliers of Single-Use system components have recognized a need to harmonize quality standards and develop consensus recommendations for implementation. The Bio-Process Systems Alliance (BPSA) has developed a series of technical guides to aid suppliers, users and regulators in the selection, qualification, validation, use and disposal of single-use systems. This presentation will review recently published BPSA Guides to Component Quality Test Methods, Irradiation and Sterilization, Extractables and Leachables, and Disposal. Jerold Martin, Director and Chair, Technology Committee, Bio-Process Systems Alliance; Senior Vice President, Scientific Affairs, Pall Life Sciences | |||
| 11:30 | Advance Interactive Panel Discussion: Unraveling Various Vendor Testing Methods End-users and manufacturers experience major challenges in ensuring appropriate testing is performed on each consumable. A strong vendor package combined with in-house testing allows for proper implementation; reducing time, cost, and simplifying training. The audience interactive panel will stimulate discussion between the end-user and top vendors highlighting whether the various tests performed and methods followed by the vendor meet the needs of the end-user. Moderator: Rachael L. Fitzgerald, Scientist, Bristol-Myers Squibb & Company Panelists: Adam Goldstein, Senior Manager, Oceanside Clinical Operations, Genentech, Inc. Jerold Martin, Director and Chair, Technology Committee, Bio-Process Systems Alliance; Senior Vice President, Scientific Affairs, Pall Life Sciences | |||
| 12:00 | End of Conference Sessions | |||
| 1:00 | Bus departs for Genentech, Inc. "2007 Facility of the Year" Site Tour Bus returns at 5pm. | |||
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