Biopharmaceutical Manufacturing & Development Summit
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Document Title
Agenda
Mitigating the Risk and Impact of Viral Contaminations: Technical Aspects
7:30
Registration and Coffee
8:20
Chairperson's Opening Remarks
Sourav K. Kundu, Ph.D., Director, Process Engineering, Amgen
Sourav K. Kundu, Ph.D., Director, Process Engineering, Amgen
8:30
Case
Study
Implementing Pasteurization of Media in Human Genome Sciences' Large Scale Manufacturing Facility to Minimize the Risk of Viral ContaminationStudy
To reduce the risk of having a viral contamination in its Large Scale Manufacturing Facility (LSM) which could result in extensive facility downtime, high clean-up costs, and supply chain headaches, Human Genome Sciences made the decision to pasteurize media being used in LSM. This presentation will focus on the development, validation, and regulatory issues associated with implementing pasteurization on a validated process. These issues include pasteurizer scale-up and characterization, viral kill studies to demonstrate the effectiveness of pasteurization, and the validation and comparability approach applied.
Scott Richmond, Senior Scientist, Human Genome Sciences, Inc.
9:00
Considerations in the Design of High Temperature Short Time Equipment for Cell Culture Media Treatment
High Temperature Short Time (HTST) treatment is an effective means of inactivating virus that may be introduced to cell culture reactors from media raw materials. Considerations must be made in the HTST system design to ensure consistent performance across equipment scales and different operating sites. This presentation will discuss the development and operational parameters investigated during the implementation of bench, pilot, and production scale HTST equipment.
Kevin P. Tolley, Senior Engineer, Global Process Engineering, Amgen
High Temperature Short Time (HTST) treatment is an effective means of inactivating virus that may be introduced to cell culture reactors from media raw materials. Considerations must be made in the HTST system design to ensure consistent performance across equipment scales and different operating sites. This presentation will discuss the development and operational parameters investigated during the implementation of bench, pilot, and production scale HTST equipment.
Kevin P. Tolley, Senior Engineer, Global Process Engineering, Amgen
9:30
An Alternative to High Temperature Short Time Media Pasteurization for Raw Material Contamination Risk Mitigation
Raw materials used in cell culture media are believed to be a primary route of entry for viral contamination of bioreactors in the biotechnology industry. HTST pasteurization of media has been used successfully as a risk mitigation measure; however, some media are not amenable to HTST. An alternative media treatment technology capable of providing virus risk mitigation will be presented.
R. Scott Rosenthal, Ph.D., Senior Scientist, Purification Process Development, Amgen
Raw materials used in cell culture media are believed to be a primary route of entry for viral contamination of bioreactors in the biotechnology industry. HTST pasteurization of media has been used successfully as a risk mitigation measure; however, some media are not amenable to HTST. An alternative media treatment technology capable of providing virus risk mitigation will be presented.
R. Scott Rosenthal, Ph.D., Senior Scientist, Purification Process Development, Amgen
10:00
Networking Refreshment Break
10:30
Risk Mitigation of Viral Contamination by HTST Technology
HTST was evaluated using multiple model viruses to determine its effectiveness in inactivating various viral contaminants. Our results show that while the technology can readily inactivate viruses such as retrovirus and reovirus to the level below the limit of detection (LOD), it is less effective in elimination more resistant parvovirus.
Dayue Chen, Ph.D., Research Advisor, Bioprocess R&D, Eli Lilly and Co.
(Live presentation will be delivered by telephone. Presenter will be at a remote location.)
HTST was evaluated using multiple model viruses to determine its effectiveness in inactivating various viral contaminants. Our results show that while the technology can readily inactivate viruses such as retrovirus and reovirus to the level below the limit of detection (LOD), it is less effective in elimination more resistant parvovirus.
Dayue Chen, Ph.D., Research Advisor, Bioprocess R&D, Eli Lilly and Co.
(Live presentation will be delivered by telephone. Presenter will be at a remote location.)
11:00
Broadening the Scope of Viral Safety Activities in Pharmaceutical Manufacturing
A viral safety program should include such elements as the execution of viral detection methods and an assessment of the viral inactivation capacity of the manufacturing process. However, even with such elements in place, viral contaminations throughout the industry do still occur. Broadening the scope of viral safety measures will be presented based on the nature of viral testing, understanding the raw materials used in the manufacturing process and past viral contamination experiences.
Ivar J. Kljavin, Ph.D., Associate Director, Quality Control Virus-Mycoplasma, Genentech, Inc.
A viral safety program should include such elements as the execution of viral detection methods and an assessment of the viral inactivation capacity of the manufacturing process. However, even with such elements in place, viral contaminations throughout the industry do still occur. Broadening the scope of viral safety measures will be presented based on the nature of viral testing, understanding the raw materials used in the manufacturing process and past viral contamination experiences.
Ivar J. Kljavin, Ph.D., Associate Director, Quality Control Virus-Mycoplasma, Genentech, Inc.
11:30
Panel Discussion with Workshop Speakers
12:00
Workshop Ends; Lunch on your Own
Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
1:00
Main Conference Registration
Plenary Session on Critical Industry Issues
1:25
Chairperson's Opening Remarks
Peter Latham, President, BioPharm Services US
Peter Latham, President, BioPharm Services US
Keynote Presentation
1:30
The Changing Face of Biopharmaceutical ManufacturingImprovements in automation and automation standards, along with the advent of disposables have revolutionized traditional biopharmaceutical manufacturing. This talk will present a brief history of the improving automation options as well as the improvements in disposable sensors, upstream and downstream disposable systems and what this all means for the future of biopharmaceutical manufacturing.
Rick Pierro, President and CEO, Superior Controls
Featured Presentation
2:15
Adventitious Agent Detection and Prevention
While the incidence of adventitious viral contamination of large-scale bioreactors is rare, any cell culture process is vulnerable to virus infection. Recently, Genzyme Corporation experienced virus contamination events. This presentation will describe the identification of Vesivirus and provide an overview of common virus mitigation and testing plans.
Nathan Jones, Ph.D., Senior Scientist, Purification Process Research, Genzyme Corporation
While the incidence of adventitious viral contamination of large-scale bioreactors is rare, any cell culture process is vulnerable to virus infection. Recently, Genzyme Corporation experienced virus contamination events. This presentation will describe the identification of Vesivirus and provide an overview of common virus mitigation and testing plans.
Nathan Jones, Ph.D., Senior Scientist, Purification Process Research, Genzyme Corporation
2:45
Building in Operational Excellence Practices into a Biotech Pilot Plant Operation from the Start
This presentation will cover how Op-Ex practices were built in from the start despite a very aggressive start-up schedule and many competing priorities. The foundational elements for success including recruitment practices, organizational design principles, leadership approach and other important elements will also be covered. The progress made to date on key aspects of the site Op-Ex program will be reviewed.
Dermot J. Gavin, Operational Excellence Leader, Pfizer Biotechnology Ireland
This presentation will cover how Op-Ex practices were built in from the start despite a very aggressive start-up schedule and many competing priorities. The foundational elements for success including recruitment practices, organizational design principles, leadership approach and other important elements will also be covered. The progress made to date on key aspects of the site Op-Ex program will be reviewed.
Dermot J. Gavin, Operational Excellence Leader, Pfizer Biotechnology Ireland
3:15
Networking Refreshment Break: Opening of Poster and Exhibit Hall
4:00
Inventory: Asset or Evil
"Inventory" is listed under the Assets banner in the balance sheet yet it is also listed as one of the seven major types of waste: muda. Can this be? This session will lead you through the intricate minefield of definitions, techniques, tricks and traps to truly understand the roles and risks of inventory in our industry.
William Botha, Plant Manager, Irvine, Specialty Therapies Facility, Baxter Healthcare Corporation
"Inventory" is listed under the Assets banner in the balance sheet yet it is also listed as one of the seven major types of waste: muda. Can this be? This session will lead you through the intricate minefield of definitions, techniques, tricks and traps to truly understand the roles and risks of inventory in our industry.
William Botha, Plant Manager, Irvine, Specialty Therapies Facility, Baxter Healthcare Corporation
4:30
Economics of Biologics Manufacturing and Novel Strategies for Cost Optimization
The following elements will be elaborated with historical data available from current manufacturers.
Srinivasan Raman, General Manager, Operations, Biologics Manufacturing, Biocon, India
Live presentation will be delivered by telephone. Presenter will be at a remote location.
The following elements will be elaborated with historical data available from current manufacturers.
- The cost landscape of the Biologics along their entire lifecycle
- The key cost components and their contributions towards total cost
Srinivasan Raman, General Manager, Operations, Biologics Manufacturing, Biocon, India
Live presentation will be delivered by telephone. Presenter will be at a remote location.
Technology Workshop
5:00
Increased focus on productivity in biopharmaceutical manufacturing has led to a larger demand for disposable process solutions. ReadyToProcessTM is a family of products that support biopharmaceutical processing from end to end. The product range is developed to achieve operational excellence by enabling LEAN manufacturing. In this workshop, the evolving landscape of flexible manufacturing solutions will be discussed. A case study of ReadyToProcess manufacturing is presented along with ROI analysis.
Jonathan Royce, North American Product Leader, GE Healthcare
5:30
Networking, Exhibit and Poster Viewing
Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
7:30
Networking Coffee
Enabling Efficient FacilitiesBuilding Scale and Product Flexibility into your Existing and New Facilities
8:00
Chairperson's Opening Remarks
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley
8:15
A Novel Method to Reduce Lactic Acid Production and Control pH in Animal Cell Culture
CHO cells can be adapted to grow in medium supplemented with high levels of lactate. One can control the metabolism of the adapted cells, as well as pH trajectory of the culture, by simply changing lactate levels and thus controlling the balance of lactate consumption versus production. Matthew S. Croughan, Ph.D., Rathmann Professor and Director, Amgen Bioprocessing Center, Keck Graduate Institute
8:45
The Impact of Freeze/Thaw and Excipients on Protein Quality
Bulk protein solutions are often stored frozen to preserve product quality. Freezing and thawing, however, can subject the solutions to conditions which negatively impact product quality. Process variables which impact solution conditions will be reviewed. Process development approaches, such as the use of appropriate scale-down models and solution surrogates where appropriate, as well as scale-up considerations will be discussed. Melissa D. Perkins, Ph.D., Director, Drug Product Sciences, Human Genome Sciences, Inc.
9:15
Case
Using CHO Cells Cryopreserved In Large Volume Bags to Initiate Cell Culture Manufacturing CampaignsStudy In an effort to shorten campaign timelines, maximize plant flexibility and resource utilization, we investigated initiation of cell culture manufacturing campaigns using CHO cells cryopreserved in large volume bags in place of the conventional seed train process. This presentation will review the development of this new technology and outline activities and challenges associated with its roll out in GMP manufacturing. Gargi Seth, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc.
9:45
Networking Refreshments, Exhibit and Poster Viewing
10:30
 Panel Discussion
11:00
Facility Rationalization: Resolving Facility-Driven, Rather than Capacity-Driven, Bottlenecks
Today industry-wide capacity is generally plentiful, but it is often not flexible enough to be configured to support new high titer processes and may be physically limited by tank sizes and WFI output. This panel will explore the issues of facility fit and process decisions effecting facility operation. Topics include:
Panelists: Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems, Inc., The Netherlands Rolf Douwenga, Vice President, Global R&D, DSM Biologics, The Netherlands Aaron Noyes, Process Engineer, Purification Process Development, Pfizer Inc. Miriam Monge, Vice President Marketing & Bioprocess Applications, Biopharm Services Ltd, United Kingdom Additional panelists to be announced
12:00
Networking Luncheon, Exhibit and Poster Viewing
Evaluating and Implementing Disposables
1:25
Chairperson's Remarks
Robert Repetto, Director, Strategy and External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer
1:30
"The Plastics Factory:" Disposables and the Bioprocess Plant of the Future
This talk will focus on a multidisciplinary and multi-site project within Pfizer to assess when, where and why the use of disposable technology makes sense in the delivery of a diverse bio-product portfolio. This assessment included quality, technical and economic assessments for stainless steel vs. disposables at various unit operations. Paul B. McCormac, Ph.D., Senior Manager, Biomanufacturing Sciences Group, Pfizer Global Manufacturing
2:00
Case
Journey up the Learning Curve: Moving to Single-Use Systems in a Largely Fixed Upstream WorldStudy This presentation will provide perspective and learnings on our efforts to deploy new single use items or systems (bioreactors) in an existing clinical cell culture production area, and learnings related to trying to achieve levels of robustness and reliability that have traditionally been seen with their stainless steel counterparts. Stacey M. Kaneshiro, Senior Consultant Engineer, Eli Lilly and Co. Technology Workshop
2:30
 This presentation will discuss the exploration of how Quality by Design (QbD) can be applied to a typical biologics molecule with regard to the A-Mab Case Study. The study provides a format to discover how the principles of QbD apply to biotechnology. Additionally, this presentation highlights both product and partnering services provided by Thermo Fisher Scientific to facilitate the successful completion of quality initiatives in bioprocess operations. William G. Whitford, Senior Manager, BioProcessing Market, Thermo Scientific Cell Culture & BioProcessing
3:00
Networking Refreshments, Last Chance for Exhibit and Poster Viewing
3:30
Integration of Disposables into a Highly Regulated Manufacturing Facility
In this unique case study we step through a recent investigation and discuss the drivers for use of disposables. Additionally, increased utilization of disposables can put a strain on supply chain. We will examine how we implemented new disposables while reducing lead time, cost and risk of other components. Joseph Kauten, Senior Scientist, Lonza
4:00
Insight through Analysis: Bioprocess Modeling and Business Analysis Tools for Disposables Selection and Integration
How do bioprocess models assist in the evaluation and selection of alternative technologies? In this talk we examine the impact of disposable technology choices comparing them to stainless steel through case studies. In particular we will look at hold bags, mixers, bioreactors and assess how decisions are influenced by scale, pricing and geographical location. We will illustrate some key points through user case study material. Miriam Monge, Vice President Marketing & Bioprocess Applications, Biopharm Services Ltd, United Kingdom
4:30
Operation of Acceleron's Single Use Facilities - Challenges of a New Technology
Disposable equipment creates the opportunity to quickly design, build, and operate pilot and GMP facilities to make proteins for preclinical and clinical work. Such facilities can be cost effective, and simple to validate and run. However, the technology is still being tested and challenges need to be overcome to operate such facilities consistently without significant disruption of a manufacturing schedule. Mauricio A. Barraza, Manufacturing Manager, Downstream Purification, Acceleron Pharma Panel Discussion
5:00
Informational Session on Industry Approaches towards Harmonization of Data Sources Regarding Disposables
Moderator: Paul B. McCormac, Ph.D., Senior Manager, Biomanufacturing Sciences Group, Pfizer Global Manufacturing (invited) Panelists:
5:30
Close of Day Two
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Manufacturing ExcellenceManaging Risk in the Increasingly Complex Supply Chain
8:00
Chairperson's Remarks
Frank Menkel, Ph.D., Associate Director, Supply Chain Management, Genentech, Inc.
8:15
Commercial and Clinical Protein Manufacturing Systems to Provide Quality, Efficiency, and Flexibility
Biogen Idec has successfully utilized a modular and platform technology transfer approach. Drug substance processes are developed and transitioned into manufacturing efficiently and with aggressive timelines. Maintaining high quality standards and robust systems, concurrent commercial and clinical production is achieved in multi-use facilities. Advanced batch modeling is used at the program, project, and shop-floor levels for efficient scheduling of resources. Sheryl Bauer, Ph.D., Director, Manufacturing Sciences, Biogen Idec
8:45
Developing Your Inventory Strategy: Key Considerations
Inventory strategy must be driven by understanding how the supply chain gives rise to the need for inventory. This presentation describes how each component of the supply chain creates the need for inventory, how evaluation of supply risk presents management decision variables for inventory investment levels and how to ensure the inventory investments continue to reflect continually changing risk profiles. Myles Marcus, Vice President, Supply Chain, Dendreon Corporation
9:15
Case
Implementation of a Scientific Risk Based Materials Clearance ProgramStudy This case study will describe how a cross-functional team, using the quality risk management principles described in ICH Q9, developed and implemented a scientific, risk-based materials clearance process for materials used in the clinical manufacturing of biological products. David C. Wolozyn, Principal Process Development Engineer, Talecris Biotherapeutics
9:45
Networking Refreshments, Exhibit and Poster Viewing
10:30
Global Material Harmonization for Increased Effectiveness and Reduced Risk
In this thought-provoking presentation, the significant opportunities for reducing cost, time, and risk profile through global material harmonization will be discussed. Theory and practice will be addressed, along with the next steps in the evolution of the process. Benjamin Locwin, M.S., M.B.A., Project Manager, Lonza Managing a Business with Tighter Resources and Higher Demand
11:00
Chairperson's Remarks
Randy Maddux, Vice President, Manufacturing Operations, Human Genome Sciences, Inc.
11:05
Assessing Operational Excellence
Striving for operational excellence begins by defining what it is you are trying to achieve and establishing a mechanism to measure and communicate progress. The challenge is doing this in an actionable, objective way. The journey begins with direct observation of processes and how staff at all levels interact with them. Keith Amelotte, Senior Manager, Project Management Organization, Amgen
11:30
Operational Excellence Management System
In describing Operational Excellence cultures, we often talk of workforces that are curious and passionate about identifying and eliminating waste in their processes. This culture is our greatest challenge to create. A management systems approach that drives leadership engagement is required to sustain the gains in both process improvements and Operational Excellence culture. Dave Bain, Director, Industrial Engineering, Amgen
12:00
Networking Luncheon, Exhibit and Poster Viewing
1:30
Case
Manufacturing Organization and StrategyStudy In this presentation the approach to building a manufacturing organization to support a commercialization and sourcing strategy will be discussed. Topics covered will include 1) building biotech manufacturing capability in an existing small molecule facility; leveraging, learning and culture 2) operating in a virtual network and 3) being flexible and how to react to strategy shifts. Diarmuid O'Connor, Business Leader for Biotech Operations, Eli Lilly S.A., Ireland
2:00
Creating Efficient Business Processes for New Product Introductions
Process transfer for new products from development into manufacturing plants is a time and resource consuming process. Development data have to be translated into ERP systems, like SAP, and into site specific recipe systems (MES and DCS). Genentech developed business processes for all commercial and clinical drug substance manufacturing plants on how to efficiently, predictably and consistently collect and deploy Product Master Data. Frank Menkel, Ph.D., Associate Director, Supply Chain Management, Genentech, Inc.
2:30
Monoclonal Antibody Purification Process and Facility Fit Optimization for Maximization of Manufacturing Network Throughput
We present an overview of Genentech's approach to monoclonal antibody purification process facility fit analysis and optimization covering a commercial manufacturing network with 6 sites and show how the use of process design and optimization tools enables maximization of plant throughput and purification of high cell culture titers. Nuno Fontes, Ph.D., Senior Engineer, Group Leader, Late Stage Purification, Genentech, Inc.
3:00
Networking Refreshments, Last Chance for Exhibit and Poster Viewing
3:30
Case
Development and Use of a Discrete Event Simulation Tool to Achieve Optimal Resources and Capacity Utilization for a Multi-Product Drug Substance FacilityStudy As the biopharmaceutical industry faces pressures to reduce manufacturing costs, the effective use of facility simulation tools to optimize capacity utilization and reduce cost is becoming increasingly important. Such a tool using a discrete event simulation strategy was developed to model the operations of a multi-product drug substance manufacturing facility. The tool development strategy, findings and lessons learned are presented. Carnley L. Norman, Ph.D., Scientist II, MedImmune, LLC
4:00
Case
Increasing the Pace: Analysis of Solutions to Process and Utility Constraints in a Biopharmaceutical Manufacturing FacilityStudy To increase run rate in a multi-product biopharmaceutical manufacturing facility, process simulation modeling was utilized to identify key bottleneck areas for improvement within the process train, water usage, and CIP skid allocation. Proposed changes were developed and verified for the intended effect using the models prior to implementation. Valerie M. Suzawa, Ph.D., Senior Engineer, Process Engineering, Vacaville Site, Genentech, Inc.
4:30
Case
Seeing the Signal in the Noise: Multivariate Analysis for Processes with Highly Variable Starting MaterialsStudy In some biopharmaceutical manufacturing systems, the component of interest in the starting material can vary widely on a batch by batch basis, and also be the primary driving factor for production outcomes. A corresponding variation in process outputs may inhibit the ability to effectively monitor or optimize downstream process performance. This case study demonstrates how a systematic multivariate analysis approach successfully identified subtle downstream process signals. Jyoti Srivastava, Senior Process Development Engineer, Talecris Biotherapeutics
5:00
Close of Day Two
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Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
7:45
Networking Coffee
Enabling Efficient FacilitiesNovel Downstream Technologies for Improved Flexibility and Efficiency
8:15
Chairperson's Remarks
Ken Green, Ph.D., Director, Technical Services, Pfizer Global Manufacturing
8:30
Case
A "Fully" Disposable Primary Recovery Step for Harvesting Mammalian Cell Culture-Processing Options and EconomicsStudy The advent of highly productive cell-culture systems for producing recombinant proteins has driven smaller batch processing that provides opportunity for transforming conventional bioprocess trains into single-use operations. We will discuss the implementation of a disposable clarification step for harvesting proteins from bioreactors containing mammalian cells. We will highlight the pros and cons for implementing this step comparing depth filtration, TFF, and centrifugation in terms of overall process performance and economics. James W. Chrostowski, Ph.D., Engineer III, Biogen Idec
9:00
Updating Unit Operation Technology for a Legacy Process
As the manufacturing and regulatory/compliance landscape changes, so too must your process. This presentation will focus on the development and implementation of updated centrifugation and associated technologies to maintain an existing process while significantly improving operations and compliance. Don M. Mather, Principal Process Development Scientist II, Talecris Biotherapeutics Technology Workshop
9:30
 A life cycle assessment (LCA) was conducted on a representative single-use assembly to better understand the environmental impacts of various stages like raw material extraction, manufacturing, logistics, use, and end-of-life. The results and recommendations from this study will be presented along with preliminary findings from an ongoing LCA comparing single-use technology with fixed-in-place stainless steel technology. Vikas Gupta, Project Manager, Milliporel Corporation
10:00
Networking Refreshments
10:30
Countercurrent Tangential Chromatography for Large-Scale Purification of High Value Proteins
Countercurrent Tangential Chromatography (CTC) is a new column-free, scalable, and disposable technology for protein purification. CTC uses a moving slurry of chromatography particles pumped through several cascades of static mixers and hollow fiber membrane modules. Chromatographic operations are performed directly on the slurry, with buffers introduced in a countercurrent direction. CTC can provide high-resolution separations with excellent protein recovery. Oleg Shinkazh, CEO, Chromatan Corporation Co-author: Andrew Zydney
11:00
Development of a Protein A SMB Step for a mAb with up to 10g/L Titers
We will review the successful purification of a monoclonal antibody from conditioned media using a Protein A affinity chromatography step run in a SMB mode with 8-12 columns run at laboratory scale. A comparison of results obtained with titers up to 10 g/L will be provided. The talk will conclude with a brief overview of the process benefits of SMB and where this technology can most efficiently be implemented. Aaron Noyes, Process Engineer, Purification Process Development, Pfizer Inc.
11:30
Case
Downstream Process Development Roadmap for a Non mAb Target ProteinStudy For downstream process development a roadmap for scale up for a recombinant target protein with emphasis on the use of in-line dilution, disposables, and real time chromatographic data analysis has been developed and used in clinical production. Based on preliminary process descriptions, PFDs, P&IDs, material balances, operability analyses, and QbD results the roadmap develops the minimum step unit operations desirable. Abhijit Banerjee, Ph.D., Fellow Engineer, Advent Engineering Services, Inc.
12:00
Close of Day Three
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Manufacturing ExcellenceRisk Management Approaches to Process Design and Manufacturing Flexibility
8:15
Chairperson's Remarks
James Kennamer, Ph.D., Vice President, Manufacturing, Talecris Biotherapeutics (tentative)
8:20
Case
Enabling Flexible Manufacturing Facilities Using Quality Risk Management ApproachesStudy Biopharmaceutical manufacturers are increasingly reexamining their existing manufacturing capacity to reduce costs while enhancing supply chain flexibility. Significant challenges lie in balancing facility flexibility and efficiency with appropriate cGMP controls and evolving regulatory expectations. Quality risk management methodologies are highly effective in achieving this balance and case study examples, approaches, and BoH feedback will be shared as illustrative examples. Kristin S. Murray, Senior Manager GCMC Regulatory Affairs, Pfizer Inc. Stephen Reich, Risk Management Principal, Pfizer Global Quality
9:00
Risk Based Approaches for Process and Product Design
Quality by Design concepts have been translated through Pfizer's Right First Time program to a systems based approach for developing process understanding during new product development. Some of the principles, tools, processes and vision to enhance the capitalization of the knowledge gathered during the lifecycle of a product will be shared. Mariah Deguara-Pagan, Senior Manager, Right First Time Program Office, Pfizer Inc. Sponsored Presentation
9:30
 Many companies are looking internally at best practices to lean operations. Are you also looking to your supply chain partners to collaborate in your initiatives? This session will discuss the opportunities that biomanufacturers have to reduce redundant activity in managing their supply chains, and thus lower total cost, instead of shifting costs upstream. Doe & Ingalls will share its Streamline model as an example of this approach. John Hollenbach, President & CEO, Doe & Ingalls
10:00
Networking Refreshments
10:30
Manufacturing Excellence track ends; participants may attend Facilities track sessions.
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Lonza Site Tour
12:15
Tour Lonza's Boston-Area Biopharmaceutical Facility
Just outside Boston, our Hopkinton, Mass., facility is a cutting-edge microbial biopharmaceutical production and R&D site for both emerging and established biotech companies. After a short presentation, you will go on a 90-minute tour of the R&D laboratories and newly opened 2,000L production suite, as well as meet with lead scientists, site managers, and top Lonza officials. The tour will give you the opportunity to learn first-hand about the latest microbial development and manufacturing technologies employed by Lonza for producing novel biotherapies. There will be ample time for discussion and Q&A.
Just outside Boston, our Hopkinton, Mass., facility is a cutting-edge microbial biopharmaceutical production and R&D site for both emerging and established biotech companies. After a short presentation, you will go on a 90-minute tour of the R&D laboratories and newly opened 2,000L production suite, as well as meet with lead scientists, site managers, and top Lonza officials. The tour will give you the opportunity to learn first-hand about the latest microbial development and manufacturing technologies employed by Lonza for producing novel biotherapies. There will be ample time for discussion and Q&A.
- Buses will leave from the Hyatt Harborside Hotel at noon Wednesday, Nov. 3 and return around 4 p.m. However, you are welcome to use your own transportation.
- Lunch and light refreshments will be provided. Participation is limited to the first 45 who register.
- To attend the site tour, please check the box on the registration form.
- The tour is available to registered conference attendees only.
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