Technology Transfer for Biopharmaceuticals
Event Information
Document Title
Agenda
| Day One Monday, March 2, 2009 | DAY ONE | DAY TWO | | ||||
| 7:00 | Registration and Coffee | |||
| 8:00 | Chairperson's Opening Remarks Amit Banerjee, Ph.D, Research Fellow, Global Biologics, Worldwide Pharmaceutical Sciences, Pfizer Inc. | |||
| Project Management Approaches and Business Strategies for Technology Transfers | ||||
| 8:15 |
Abstract to come. Robert Shell, Principal Scientist, Bioprocess Research and Development Laboratories, Global Biologics, Pfizer Inc. | |||
| 8:45 |
Based on a recent project, this presentation will review the CMO's perspective on the requirements to manage a successful project throughout its different phases. The review will include how to manage the key interactions with the client, how to manage the client's expectations and ensure your project team delivers. Claire Tupman, MBA, Senior Program Manager, Avecia Biologics, United Kingdom | |||
| 9:15 | What do We Use as Metrics to Define the Success of a Transfer? The finish line for Tech Transfer is defined differently by each and every company. The level of success in reaching these finish lines can be defined and measured with some common metrics. When established properly, these metrics will provide an objective confirmation of successful technology transfer as well as insight into improvement opportunities. This talk will focus on these metrics and their application. Rich Getto, M.S., MBA, Senior Engineer-Business Process Owner, Technology Transfer, Global Process Engineering, Amgen Inc. | |||
| 9:45 |
Corporate partnerships and global operations for Biopharmaceuticals companies have become common place over the last twenty years, increasing the complexity of manufacturing networks and technology transfers to those networks. This presentation will focus on development of strategies for, and management of, a multi-company, multi-site technology transfer as well as lessons learned. John Herberger, Senior Manager, Global Operations, Amgen Inc. | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| 11:00 | Development and Implementation of a Technology Transfer Business Process Within the Genentech Biologics Manufacturing Network Genentech's bulk manufacturing network has undergone significant expansion in order to meet the demands of its product portfolio. With this growth has come increased complexity and frequency of process transfers within the network. This talk highlights the development and implementation of a sustainable business processes for technology transfer toward our goal of achieving world class manufacturing. Eric Fallon, Ph.D., Associate Director, Manufacturing Sciences and Technology, Genentech, Inc. | |||
| 11:30 | Success Factors and Challenges in the Management of Process Transfer Projects Successful coordination of process transfer activities is crucial for process implementation in a production facility. Numerous activities have to be considered to support agreed time-to-market milestones, such as technical process aspects and organizational / management aspects. The presentation summarizes the best practice in project management as strong business tool to meet the timelines of agreed key deliverables. Markus Baur, Ph.D., Director, Project Management Group, Biopharmaceuticals, Boehringer Ingelheim GmbH & Co. KG, Germany | |||
| 12:00 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| 1:25 | Chairperson's Remarks Ashley Westlake, Global Director, Technology Transfer, Lonza Biologics, United Kingdom | |||
| Keynote Address | ||||
| 1:30 | Failed Tech Transfers: Learning our Lessons the Hard Way For most of us, we learn more from our mistakes than from our failures. Tight timelines, intense pressure, and limited experience often lead us to take risks and challenge ourselves to meet goals that may not be realistic. Occasionally we fail, and in those darkest days come some of the best insights and understanding about the true nature of the challenges we face. E. Morrey Atkinson, Ph.D., Director, Bioprocess R&D, Eli Lilly and Company | |||
| Strategies and Approaches to Developing a Process that is Transferrable and Robust | ||||
| 2:00 |
Successful scale-up and technology transfer require process understanding, which is achieved through investment in process development and characterization. Unfortunately, even significant up-front investment cannot eliminate all challenges encountered during technology transfers. This case study reviews challenges encountered during the transfer of a well-characterized process to a contract manufacturing organization. Detailed process understanding was critical for rapid troubleshooting and issue resolution. Gregg B. Nyberg, Ph.D., Principal Scientist, Amgen Inc. | |||
| 2:30 |
Unique challenges exist for transfers of older products that may not have been characterized to the extent that a modern process would be. Process modifications due to facility constraints must be handled conservatively, and additional studies may be required to better understand the current state of the process and the proposed change. Highlights from a recent case study will be described. Kathy Carswell, Ph.D., Senior Engineer, Global Manufacturing Science and Technology, Genentech, Inc. | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| Transfer of Analytical Methods | ||||
| 3:45 |
Analytical assessment of product quality attributes is a critical component of site-to-site comparability exercises. Differences in analytical comparability may necessitate in-depth characterization of manufactured drug substance or drug product. In this case study, we will discuss comparability studies involved in a site-to-site transfer of a monoclonal antibody drug substance manufacturing process, differences observed in charge species monitored using orthogonal techniques, and additional analytical characterization conducted to elucidate the differences. Athena D. Nagi, Ph.D., Principal Scientist, Analytical Sciences, Amgen Inc. | |||
| 4:15 | Method Transfer - A Plethora of Ways Method transfer will be presented from the viewpoint of a contract laboratory. The presentation will cover several transfer scenarios and pinpoint potential red flags depending on the type of method and technology, level of performance, planned applications, and the countering of issues that may arise. Wolfgang Klump, Ph.D., Senior Manager, Analytical Services, SAFC Phama | |||
| 4:45 | Approaches to Assay Qualification and Validation in Support of Successful Technology Transfer This presentation will focus on various approaches to support assay qualification and validation in support of successful tech transfer with specific case studies. The presentation will detail assay qualification and validation challenges, process and analytical considerations to be examined at the planning stage, approaches to experimental design, setting specifications in support of validation, and opportunities for co-validation. Paula Carrigan, Analytical Sciences Manager, Pilot Lab Development, Wyeth Biopharma, Ireland | |||
| 5:15 | Networking Cocktail Reception in Exhibit Hall with Poster Viewing | |||
| Day Two Tuesday, March 3, 2009 | DAY ONE | DAY TWO | | ||||
| 7:30 | Coffee | |||
| 8:00 | Chairperson's Opening Remarks Jean Bender, Ph.D., Senior Engineer, Genentech, Inc. | |||
| Challenges of Facility Fit for High Capacity Processes and Overcoming Downstream Bottlenecks | ||||
| 8:15 |
Increased expression levels for newer cell culture processes, changing product demand scenarios for existing marketed products, and alternate formulations for new drug substance purification processes have necessitated some changes to an existing manufacturing plant. This case study will focus on modifications required for one antibody facility to handle 2-4 fold cell culture titer increase, produce high concentration drug substance for subcutaneous administration, and manufacture a non-antibody protein product. The talk will present creative approaches to facility fit analyses through process intensification, operational and engineering solutions. Carol D. Basey, Manufacturing Technical Specialist, Genentech, Inc. | |||
| 8:45 | Designing and Implementing a "Design for Manufacturability Program" This presentation will elaborate on the various tools and processes that one can develop and leverage in a design for manufacturability program, how to implement these processes within their organization, and discuss how such processes were either used successfully or not so successfully in specific technical transfer programs. In those cases where DFM principles were maintained the goals for the transfer project were successfully achieved. In those cases where DFM principles were not employed, project timelines and budgets were not met. Mike DiPaolo, Manager, Centocor Pharmaceutical Development, Centocor R&D Sandy Hackman, Director of Project Management, Therakos Corporation | |||
| 9:15 |
Bristol-Myers Squibb Co. (BMS) is in the midst of a $750 million capital investment in a Large Scale Biologics Manufacturing facility located in Devens, MA. The facility will be capable of manufacturing multiple products on a campaign basis, and many process options for each of these products exist. A simulation-based optimization model of the facility that could handle the inherent process variability and could easily be updated with current data was created for facility fit assessment of these process options. This case study outlines the methodology and selected results. Chris Stevens, M.S., Manager, Process Support, Bristol-Myers Squibb Co. | |||
| 9:45 |
High volume biotechnology products produced using microbial expression systems present unique facility fit challenges not typically encountered with mammalian cell culture processes. These span not only the spectrum of process requirements for fermentation through recovery and purification operations but also ancillary facility features such as cleaning, raw materials and waste handling, and plant scheduling to support a fast run rate. This presentation will present some recent experiences at Amgen along with approaches to overcome the challenges. Arun Tholudur, Ph.D., Principal Engineer, Process Development, Amgen Inc. | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| Featured Presentation | ||||
| 11:00 | Application of Quality by Design Principles during Process Technology Transfer Wyeth Biotech has a number of programs underway to introduce the principles and tools of Quality by Design into the development and manufacture of its biotechnology-derived products. This presentation will describe some of these initiatives, and focus on their application in late-stage-development and commercial manufacturing phases of operation. Illustrative references will be made to a technology transfer of a recombinant protein manufacturing process into the Grange Castle manufacturing plant in Ireland. Enda Moran, Ph.D., Associate Director, Process Development, Wyeth Biotech, Ireland | |||
| 11:30 | Technology Workshop IBC's Technology Workshops offer companies the opportunity to present product and/or service offerings directly to the audience at the Technology Transfer for Biopharmaceuticals conference. For more information on presenting, please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com. | |||
| 12:00 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| 1:25 | Chairperson's Remarks Siddharth J. Advant, Ph.D., Principal, Tunnell Consulting | |||
| Featured Case Studies | ||||
| 1:30 |
Abstract to come. William O'Dwyer, Senior Research Associate, Late Stage Purification, Genentech, Inc. Johannes Salzbrunn, M.S., Head of Downstream Pilot, Process Science, Boehringer Ingelheim RCV GmbH & Co. KG, Austria | |||
| 2:00 |
This presentation will explore the critical nature of communication during the technology transfer process. Highlights from a recent case study will detail the "hows" and "whys" with specific examples of defective communication and how it impacted the success of the transfer. Jon T. Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc. | |||
| 2:30 |
Systematic development and technology transfer is critical for successful commercialization of new products. This presentation will discuss how this was implemented one at a large company with multiple business platforms (e.g. Small molecules, biotech, vaccines). This includes linking internal business processes, technology development guidelines, regulatory and quality & compliance requirements. Challenges in implementing and managing such a system, as well as, advantages of such a system in implementing new corporate wide initiatives (e.g. QbD) will be discussed. Ranjit Deshmukh, Ph.D., Senior Director & Process Owner, Technology Development and Transfer Process, Global Quality Operations, Wyeth Pharmaceuticals | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| External Transfers of Drug Substance and Product to CMOs | ||||
| 3:30 |
In case of fully used in house manufacturing capacities, contracting out of GMP production is common part of the daily business in biologicals development and production. This presentation will summarize our experience in outsourcing of GMP projects for clinical and commercial use. The benefits and potential pitfalls for both applications will be evaluated and compared. Berthold Boedeker, Ph.D., Head of Pilot Plants and Cell Culture, GDD-CMC Biotech Development, Bayer Healthcare AG, Germany | |||
| 4:00 | Applying Risk Management to Technology Transfer Programs We are currently adding risk assessment management to our technology transfer programs. This risk-based approach was implemented to: identify parameters that could impact product quality or safety, define critical processes/components required for correct operation, determine possible consequences of the identified risk and propose additional measures to reduce the risks to an acceptable level. Post-program evaluation of identified risk was performed to confirm that the scope of the risk management evaluation was complete and adequately encompassed known and unknown challenges to the program success. The presentation will outline the highlights of the application of risk assessment analysis coupled with technology transfer programs. Eddie Baran, Associate Director, Process Sciences, Diosynth-RTP Inc., Diosynth Biotechnology, a part of Schering-Plough | |||
| 4:30 |
Technology transfer after product discovery and process development is one of the key factors for the success of entire project. In this presentation, critical factors that both donor and receiving sites should consider for better and efficient communication will be addressed from both technical and project management perspectives. In addition, things required for international technology transfer will be presented. Yong-Jick Kim, Ph. D., Senior Vice President, Manufacturing Operations, Celltrion Inc., Korea | |||
| 5:00 | Close of Conference | |||
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