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Agenda
Assessing and Preventing the Risk of Using Disposables
7:30
Coffee and Registration
8:15
Chairperson's Opening Remarks
Ekta Mahajan, Senior Engineer, Genentech, Inc.
Ekta Mahajan, Senior Engineer, Genentech, Inc.
8:30
Risk Mitigation Strategies for Disposable Materials
This presentation will explore Risk Mitigation Strategies for single-use production systems and components. These strategies will focus on an enhanced supplier relationship model, quality and functional requirements as they relate to the process requirements, and the financial implications. Supplier owned safety stock inventories becomes more important as well as the ability of the supply industry to make their products interchangeable with other suppliers' products.
Leslie B. Cianella, Strategic Sourcing Manager, Procurement, Genentech, Inc.
This presentation will explore Risk Mitigation Strategies for single-use production systems and components. These strategies will focus on an enhanced supplier relationship model, quality and functional requirements as they relate to the process requirements, and the financial implications. Supplier owned safety stock inventories becomes more important as well as the ability of the supply industry to make their products interchangeable with other suppliers' products.
Leslie B. Cianella, Strategic Sourcing Manager, Procurement, Genentech, Inc.
New, Unpublished Data
9:00
Case
Study
What to Do when There Is a Change to a Polymeric/Plastic, Raw-Material Based Product?Study
Change notices provided by a supplier to an end-user will sometimes involve a raw material change of a key single use disposable item. Case studies will be discussed based on plastic material changes typically found with single use disposable products. The studies will describe how the changes were implemented and how they can be implemented more easily and faster for future projects.
Trishna Ray-Chaudhuri, Ph.D., Technical Consultant, Trishna LLC
9:30
Applying QbD Principles to Manufacturing with Single Use Systems
A QbD approach to Process Development offers significant advantages at commercialization. This presentation will outline the application of Risk Management, Quality by Design, and statistical process monitoring to the decision-making, implementation and qualification processes for single use manufacturing operations.
Robert Repetto, Director, External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer
A QbD approach to Process Development offers significant advantages at commercialization. This presentation will outline the application of Risk Management, Quality by Design, and statistical process monitoring to the decision-making, implementation and qualification processes for single use manufacturing operations.
Robert Repetto, Director, External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer
10:00
Networking Refreshment Break
10:30
Risk Mitigation with Disposables
Single-use technology offers big risk mitigation advantages over traditional bioprocessing platforms. Our industry is rapidly adopting disposable systems for the obvious quality benefits - minimizing cross contamination and reducing the impact of failure events. This presentation expands the focus to include not only the obvious, but also mitigation of other business-related risks with traditional approaches such as lost speed, process-dependency, and poor asset utilization.
Lisa Alexander, Vice President, Regulatory and Quality, Xcellerex, Inc.
Single-use technology offers big risk mitigation advantages over traditional bioprocessing platforms. Our industry is rapidly adopting disposable systems for the obvious quality benefits - minimizing cross contamination and reducing the impact of failure events. This presentation expands the focus to include not only the obvious, but also mitigation of other business-related risks with traditional approaches such as lost speed, process-dependency, and poor asset utilization.
Lisa Alexander, Vice President, Regulatory and Quality, Xcellerex, Inc.
New, Unpublished Data
11:00
Case
Study
Process Development and Process Validation of Biotherapeutics Manufacturing Using Single-Use SystemsStudy
To manufacture a sterile solution of a protein therapeutic product from plasma, disposable systems were implemented. The evaluation of extractables and leachables was performed as part of the process validation. The validation strategy included conducting a risk assessment, matrixing products, and selecting reasonable worst-case test conditions. The safety and quality impacts of extractables and leachables on protein products were assessed.
David M. Weber, Senior Manager, Process Development, R&D, CSL Behring Weibing Ding, Ph.D., Senior Technical Manager, Scientific and Laboratory Services, Pall Life Sciences
Panel Discussion
11:30
Industry/Supplier Panel Discussion: Risk Mitigation Strategies for Implementation of Disposables
Ekta Mahajan, Senior Engineer, Genentech, Inc.
Panelists:
Jeffrey Carter, Director of Research and Development, GE Healthcare
Leslie B. Cianella, Strategic Sourcing Manager, Procurement, Genentech, Inc.
Weibing Ding, Ph.D., Senior Technical Manager, Scientific and Laboratory Services, Pall Life Sciences
Mani Krishnan, Program Director, Single-Use Processing Systems, EMD Millipore
Robert Repetto, Director, External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer
- Technical understanding of raw materials
- Impact of sterilization on disposables components
- Validation of supplier data
- Is use of disposables "just" a MOC change?
- Are we ready for commercial applications?
- Standardization of extractable and leachable studies across industry
- Gaps between supplier and end user requirements
Ekta Mahajan, Senior Engineer, Genentech, Inc.
Panelists:
Jeffrey Carter, Director of Research and Development, GE Healthcare
Leslie B. Cianella, Strategic Sourcing Manager, Procurement, Genentech, Inc.
Weibing Ding, Ph.D., Senior Technical Manager, Scientific and Laboratory Services, Pall Life Sciences
Mani Krishnan, Program Director, Single-Use Processing Systems, EMD Millipore
Robert Repetto, Director, External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer
12:15
Workshop Ends; Lunch on your own
12:30
Main Conference Registration Begins
Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
1:25
Chairperson's Opening Remarks
Randy Maddux, Vice President, Manufacturing Operations, Human Genome Sciences, Inc.
Randy Maddux, Vice President, Manufacturing Operations, Human Genome Sciences, Inc.
Keynote Presentations
1:30
Deploying Business Process Excellence in Biologics ManufacturingGenentech Oceanside deployed Business Process Excellence in 2007. By the summer of 2009 Oliver Wight International recognized them for achieving "Class A" certification with their production operations. Greater than 80% of companies embarking on this improvement journey fail to be certified by Oliver Wight. Learn about this intriguing transformation from the person tasked to get this initiative off the ground and to achieve Class A certified operations within two years.
James R. Kasselmann, Director, Clinical Manufacturing, Genentech, Inc.
2:05
Next Generation Process in a New Biotechnological FacilityIs high titre everything? How can "right first time" be achieved during technology transfer (TT) into a new facility? How should obstacles be handled to minimise their impact on timeline and cost? How will TT be affected by the fact that more facilities must accommodate multiple products? Hear an analysis of the technical capabilities and additional interaction required to get new processes into already existing facilities in the context of Pfizer's new award-winning facility.
Kim Sandell, Director, Operations Management & Operational Excellence, Pfizer, Sweden
2:40
Amgen's Perspective on Manufacturing of the FutureA new paradigm, in which biotechnology products can be manufactured more efficiently and more cost-effectively than today, is essential. Our analysis of cost pressures, new technologies and ever changing products and markets suggests that increased manufacturing flexibility will be required for the future. Technology advancements and a new operating philosophy will allow Amgen to successfully transition and prepare for the future.
Stephen J. Hill, Executive Director, Manufacturing Technology, Amgen
3:15
Networking Refreshment Break; Opening of Poster and Exhibit Hall
4:00
What's Next after Achieving Rapid Capacity Increase and Flexibility through the Use of Disposables?
BioMarin recently completed construction, qualifying and commenced processing in its newly expanded facility for commercial and clinical products. The facility start-up time was greatly reduced by implementation of numerous disposable systems and applications. This talk will touch upon the scope and processes BioMarin used to design and implement systems but will focus on current efforts to improve existing systems, integrate engineering and automation controls and challenge the concept of "single-use."
Chris M. Brodeur, Senior Operations Manager, Commercial Manufacturing, BioMarin Pharmaceuticals
BioMarin recently completed construction, qualifying and commenced processing in its newly expanded facility for commercial and clinical products. The facility start-up time was greatly reduced by implementation of numerous disposable systems and applications. This talk will touch upon the scope and processes BioMarin used to design and implement systems but will focus on current efforts to improve existing systems, integrate engineering and automation controls and challenge the concept of "single-use."
Chris M. Brodeur, Senior Operations Manager, Commercial Manufacturing, BioMarin Pharmaceuticals
4:35
Shire's Manufacturing Strategy and New Flexible Facility: Completely Disposable Upstream and Traditional Stainless Downstream
Shire Human Genetic Therapies, Inc. (Shire HGT) develops and manufactures biopharmaceuticals for rare orphan diseases. Due to an increase in patient demand, Shire HGT expanded its manufacturing operations with a new flexible multi-product facility. The upstream was designed completely disposable to speed the facility design, reduce complexity, and be flexible to host multiple products. The downstream was designed with flexibility to processing multiple products, uses disposable technology where possible, but uses more traditional equipment designs. Overall, the new Shire HGT manufacturing facility is a flexible design that can be adapted to many different biopharmaceutical processes.
James Stout, Ph.D., Associate Director, Purification PD, Shire Human Genetic Therapies
Shire Human Genetic Therapies, Inc. (Shire HGT) develops and manufactures biopharmaceuticals for rare orphan diseases. Due to an increase in patient demand, Shire HGT expanded its manufacturing operations with a new flexible multi-product facility. The upstream was designed completely disposable to speed the facility design, reduce complexity, and be flexible to host multiple products. The downstream was designed with flexibility to processing multiple products, uses disposable technology where possible, but uses more traditional equipment designs. Overall, the new Shire HGT manufacturing facility is a flexible design that can be adapted to many different biopharmaceutical processes.
James Stout, Ph.D., Associate Director, Purification PD, Shire Human Genetic Therapies
5:15
Networking in Poster and Exhibit Hall
Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
8:00
Networking Coffee
Enabling Flexible FacilitiesStrategic Decisions for Enabling Flexible Facilities
8:30
Chairperson's Opening Remarks
Sourav K. Kundu, Ph.D., Director, Process Development, Amgen New, Unpublished Data
8:45
Case
A Risk-Based, Scientific Approach to Multi-Product OperationsStudy Many biologics manufacturing facilities produce multiple products. This requires rapid and cost effective changeovers in between product campaigns in order to preserve capacity and control costs. This talk will describe ImClone's risk-based, scientific approach to multi-product operations and product changeovers in its multi-product manufacturing facility. This facility produces materials from multiple cell lines for both clinical and commercial use. Todd D. Winge, Vice President, Biologics Manufacturing, Process Engineering, and Logistics, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company New, Unpublished Data
9:15
Case
Incorporation of Disposable Technology Platforms into Existing Biopharmaceutical FacilitiesStudy Hospira is involved in the development and manufacture of high quality biosimilar products. This presentation will focus on the challenges and benefits of deploying multiple manufacturing platforms within the same facility, with a focus on case studies describing specific issues and solutions. The comparative costs, space utilization considerations, product development benefits and quality implications of these competing manufacturing platforms will be discussed. Meera M. Verma, Ph.D., Director, Site Operations, Global Biologics R&D, Hospira, Australia New, Unpublished Data
9:45
Case
Flexible Manufacturing Facility Using Disposable TechnologyStudy Hear Biogen Idec's case study on their flexible manufacturing strategy, development design, and regulatory experience with disposable facilities. Lynn Conley, Associate Director, Technical Development, Biogen Idec
10:15
Networking Refreshment Break, Exhibit and Poster Viewing
10:45
Case
Small Scale Monoclonal Antibody Manufacturing Sourcing: Financial Analysis and Decision-Making Process for CMO vs. In-House ManufacturingStudy Manufacturing of small scale biologics drug substance for early stage clinical trials presents unique challenges when balancing between costs and meeting tight clinical trial timelines. This presentation discusses a case study of the Make vs. Buy analysis for small-scale manufacturing of clinical monoclonal antibody clinical material. Manufacturing costs, timelines and optimization of the internal manufacturing network are considered. Polina Rapoport, Site Manager, Pharma Technical Manufacturing Development, Genentech, Inc.
11:15
The Reality of Closed Single Use Processing: Maximizing your Gray Space
As has been the case with the advent of any new manufacturing technology, the immortal allure of closed processing has raised interest in what advantages single use technology may provide. The presentation will discuss some of the facts and myths of closed processing and how single use technologies enable or hinder the implementation of an entirely closed manufacturing capability. Parrish Galliher, President and Chief Technology Officer, Xcellerex, Inc. Technology Workshop
11:45
Scalability and Flexibility in Single-Use Technology
Single-Use Technologies (SUT) support most production train segments with advantages in capital investment, COG, safety, scheduling, surge capacity and process replication. Optimization in bench-top SUT is now transferred to 2000L SUT reactors, while maintaining similar probes, porting, and control. "Flexible manufacturing" maintains cGMP while accommodating campaign schedule and production scale change; reconfigurability for multiple product portfolios; and multiple production platforms. William G. Whitford, Senior Manager, Marketing, Thermo Fisher Scientific Sponsored by 
12:15
Luncheon in Exhibit and Poster Hall
Scale Up and Guidance for Implementation
1:40
Chairperson's Remarks
Adam Goldstein, Principal Scientist, Genentech, Inc.
1:45
Approaches to the Use of Disposables for Clinical Manufacturing at Alexion's Rhode Island Manufacturing Facility (ARIMF)
Manufacture of Alexion's diverse product pipeline requires multiple manufacturing processes. This necessitates a flexibility manufacturing facility. Historical use of disposables at ARIMF and new opportunities under consideration will be discussed. A cost/benefit comparison of select disposables to fixed equipment will also be presented. This comparison will consider material costs, shelf life, volume flexibility, scheduling constraints, and product impact risk reduction. Alfred W. Boyle, Ph.D., Director, Technical and Clinical Manufacturing Services, Alexion Pharmaceuticals New, Unpublished Data
2:15
The Introduction of Disposables into Drug Product Operations on a Large Scale Basis
Disposables have been utilized in the biopharmaceutical industry to increase efficiency and reduce manufacturing cost. Disposable use in drug substance manufacturing processes has matured from buffer bags to fully disposable unit operations. Until recently, most filling operations were done with standard equipment. The presentation discusses new technologies and implementation strategies that will bring the cost and efficiency benefits of disposables to drug product manufacturing. Kellen Mazzarella, Engineer 2, Pharmaceutical Processing and Technology Development, Genentech, Inc. Technology Workshop
2:45
Integrating a Single-Use TFF System into a New cGMP Biomanufacturing Facility – A Case Study
CMC Biologics, a contract manufacturer of biologic therapeutics, has recently expanded its cGMP contract manufacturing capabilities, including a new 500L scale clinical facility that emphasizes single-use technology. In evaluating options for final UF/DF steps, Novasep Sius Single Use TFF systems were chosen based on performance, cost, operational similarity to traditional methods, and a single use flow-path option. This case study will describe the evaluation and successful implementation of the Sius system into this facility. Barb Thorne, Ph.D., Independent Consultant Todd A. Wilkie, Process Technology Specialist, Manufacturing CMC Biologics, Inc. Sponsored by 
3:15
Refreshment Break and Last Chance for Poster and Exhibit Viewing
Panel Discussion
4:00
Update on Industry Approaches towards Harmonization of Data Sources Regarding Disposables
Moderator: Paul B. McCormac, Ph.D., Senior Manager, Biomanufacturing Sciences Group, Pfizer Global Manufacturing Introduction to the Discussion
Industry Data Sources Website: A Collection of Industry Abstracts of Single-Use and Disposable Documents and Articles - A Collaborative Effort by ISPE, BPE, BPSA and PDA
Learn about the benefits of an online directory where industry professionals can access white papers, technical reports and documents, and articles relating to implementation, waste management of disposable technologies, ROI determinations, validation, and other key issues concerning the conversion to single-use / disposable processes. Representing ISPE Disposables Group: Ken Baker, CEO, NewAge Industries / AdvantaPure Adam Goldstein, Principal Scientist, Genentech, Inc.
Development of a Quality Agreement Template for Single-use Suppliers and Users
Using established templates developed by FDA for contract biological manufacturing, by IPAC-RS for OINDP manufacturing, and SOCMA for bulk pharmaceutical manufacturing, the BPSA has undertaken to develop a Quality Agreement Template for single-use manufacturing that will aid suppliers and users in establishing formal quality agreements. An update on ELSIE activities will also be provided. Representing BPSA: Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
PDA Task Force for Single Use Systems, Presents a Technical Report Overview
The lack of a roadmap and best practices for the implementation of single use technologies in pharmaceutical manufacturing has been a recognized challenge within the industry. The Parenteral Drug Association has developed a technical document establishing a framework by which organizations can establish a manufacturing strategy for implementing single use technologies with special consideration for their individual needs, goals and competencies. Robert Repetto, Director, External Affairs, BioTherapeutics Pharmaceutical Sciences, Pfizer Audience Interactive Discussion
Panelists will include presenters listed above as well as:
Representing ASME-BPE: Ted Hutton, Business Development Manager, Arkema Inc.; Chairman, ASME BPE Polymer Material (PM)
5:30
Close of Tuesday Sessions
|
Biomanufacturing ExcellenceContinuous Processing
8:30
Chairperson's Remarks
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley
8:45
Can Continuous Purification of Biopharmaceuticals Become a Reality?
Most biopharmaceutical products are manufactured using "tried and true" batch processing methods, which are effective but inherently less capital-efficient than continuous processing methods. Adoption of continuous processing approaches presents challenges, including regulatory uncertainties and the design and complexity of conventional continuous-processing equipment. This talk will focus on approaches that may be used to address these challenges and realize implementation of continuous processing technologies for biopharmaceutical manufacturing. Thomas C. Ransohoff, Vice President, BioProcess Technology Consultants, Inc. New, Unpublished Data
9:15
Case
Stepping into the Future Continuously - Working towards an Integrated Antibody Purification ProcessStudy To address the inefficiencies associated with traditional batch-based protein purification processes, it is desirable to integrate individual downstream unit operations into a single continuous paradigm. This presentation will focus on the use of emerging technologies to construct a continuous, disposable bioprocess specifically focused on the integration of the initial steps in a platform CHO-based antibody purification process. Mark A. Brower, Ph.D., Senior Research Chemical Engineer, Biologics New and Enabling Technologies, Merck & Co., Inc. Panel Discussion
9:45
Continuous Processing Sponsored by:
Moderator: Thomas C. Ransohoff, Vice President, BioProcess Technology Consultants, Inc. Panelists: Mark Brower, Ph.D., Senior Research Chemical Engineer, Biologics New and Enabling Technologies, Merck & Co., Inc. Jon Petrone, Vice President, Technical Services, Pall Life Sciences Additional panelists to be announced Sponsored by 
10:15
Networking Refreshment Break, Exhibit and Poster Viewing
Technology Workshop
10:45
Achieving High Concentration Antibody Formulations using Single-Pass TFF
Single-pass TFF technology can be used to concentrate protein solutions to high levels in a single pump pass. The technology results in more compact systems than traditional TFF due to its reduced flow rate requirements and simple control methods. This presentation will focus on performance data for the concentration of antibody solutions to >200 g/L with high product recovery. Jon Petrone, Vice President, Technical Services, Pall Life Sciences Sponsored by
Continuous Improvements to Improve Speed, Cost Savings and CompetitivenessChairperson: Peter Latham, President, Latham BioPharm Group New, Unpublished Data
11:15
Case
Process Adaptations and Improvements in Commercial Biologics Manufacturing for Increased Robustness and Risk MitigationStudy Applying new technologies driven out of development in new and existing manufacturing processes and assets becomes more important to increase efficiency, mitigate risk (financial & supply chain risk) without compromising quality. A case study focusing on necessary process adaptations due to facility fit and the implementation of several new technologies (e.g. HTST, disposables) will be presented and discussed in this presentation. Michael Pohlscheidt, Ph.D., EMBA International SCM, Associate Director, Manufacturing Sciences and Technology, Oceanside Product Operations, Genentech, Inc. New, Unpublished Data
11:45
Case
Strategies for the Development and Manufacturing of BiosimilarsStudy The availability of biosimilars is one of the obvious solutions to increase the accessibility of protein therapeutics for patients and to lower the healthcare cost for the societies. The strategies of developing and manufacturing biosimilars with high quality and low cost to meet the requirements will be presented. Judy Chou, Ph.D., Vice President, Research and Development, Tanvex Biologics Inc.
12:15
Luncheon in Exhibit and Poster Hall
Supply Chain Risk Mitigation
1:40
Chairperson's Remarks
Myles Marcus, Vice President, Supply Chain Management, Dendreon Corporation
1:45
Supply Chain Risk and Sole Sourcing: Survey Results and Lessons from Other Industries
Lean supply chain efforts in many industries have resulted in firms moving towards sole sourcing arrangements. By eliminating redundancy, a key risk mitigation tool, these arrangements lead to a need for alternative risk management approaches. In this presentation, we explore results of our ongoing survey of biopharmaceutical supply chain risks, and discuss lessons learned from our work with other industries. Phil Kaminsky, Ph.D., Professor; Director, Initiative for Research in Biopharmaceutical Operations, Industrial Engineering and Operations Research, University of California, Berkeley
2:15
Mitigating the Impact of Raw Materials: A Risk-Based Approach
Raw materials constitute one of many factors that can influence the successful and consistent performance of a biopharmaceutical manufacturing process. Such raw materials can significantly impact process outputs, such as: product quality and safety, productivity, process consistency and impurity profiles. This overview provides a systematic, risk based approach to managing raw materials throughout a product lifecycle. Paul Lewus, Ph.D., Principal Engineer, Product and Process Engineering, Amgen Inc. Technology Workshop
2:45
Integrating a Single-Use TFF System into a New cGMP Biomanufacturing Facility – A Case Study
CMC Biologics, a contract manufacturer of biologic therapeutics, has recently expanded its cGMP contract manufacturing capabilities, including a new 500L scale clinical facility that emphasizes single-use technology. In evaluating options for final UF/DF steps, Novasep Sius Single Use TFF systems were chosen based on performance, cost, operational similarity to traditional methods, and a single use flow-path option. This case study will describe the evaluation and successful implementation of the Sius system into this facility. Barb Thorne, Ph.D., Independent Consultant Todd A. Wilkie, Process Technology Specialist, Manufacturing CMC Biologics, Inc. Sponsored by
3:15
Refreshment Break and Last Chance for Poster and Exhibit Viewing
Risk Management Approaches to Process Design and Technology TransferChairperson: Rick Johnston, Ph.D., Executive Director, CELDI Center for Research in Biopharmaceutical Operations, University of California at Berkeley New, Unpublished Data
4:00
Case
Prediction of Mammalian Cell-Culture Performance and Product Quality Attributes with Analytical Measurements of Raw Material IngredientsStudy Raw materials and media, cell-cultures and product quality attributes are characterized with analytical spectroscopy and multivariate calibration models. Their correlations are quantified and investigated if one can obtain information for raw material lot screening, consistency increase of cell-culture performance, and productivity increase. Preliminary data indicates possibility of paradigm shift for cell-culture operation from "recipe-based" to "process control." Seongkyu Yoon, Ph.D., Assistant Professor, Chemical Engineering and Massachusetts Biomanufacturing Center Director, University of Massachusetts, Lowell Andrew Christie, Ph.D., Principal Scientist, SAFC Biosciences New, Unpublished Data
4:30
Case
Advanced Process Control: Discrete Data Multivariate Models for Chromatography MonitoringStudy Characterizing the relationship between input and output variables of chromatography operations is critical to process monitoring, optimization and ultimately, prediction. This presentation discusses Biogen Idec's strategy for chromatography analysis and monitoring using key process parameter discrete data. This approach leverages the power of multivariate analysis and process knowledge to enhance process understanding and improved process performance. Robert A. Genduso, Scientist II, Manufacturing Sciences, Biogen Idec
5:00
Biomanufacturing Excellence in Early Phase Clinical Manufacturing
The application of manufacturing excellence concepts in early stage clinical manufacturing enables efficient technology transfer and improved organizational learning. This presentation will review some of key concepts employed at HGS and their impact on technology transfer. Justin R. Horvath, Senior Project Coordinator, Technical Services, Human Genome Sciences
5:30
Close of Tuesday Sessions
|
Symposium: Monday | Main Conference: Monday | Tuesday | Wednesday
Novel Downstream Technologies for Managing High Titers including Disposables
Session Sponsored by
8:20
Chairperson's Remarks
Todd D. Winge, Vice President, Biologics Manufacturing Process Engineering, & Logistics, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company
Todd D. Winge, Vice President, Biologics Manufacturing Process Engineering, & Logistics, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company
8:30
A Comparison of Protein A, Non-Protein A, and Disposable Downstream Processes for a Monoclonal Antibody from Fed-Batch and Intensified Cell Culture Harvests
Advances in downstream technologies have addressed many challenges in the purification of mAbs, such as reducing cost and time by introducing high capacity capture steps and single-use technologies. This study compares three mAb purification processes: a Protein A based process as a benchmark for comparing a high capacity ion exchange (column based) process and a process based on single-use technologies.
Michael Kuczewski, Scientist I, Percivia LLC
Advances in downstream technologies have addressed many challenges in the purification of mAbs, such as reducing cost and time by introducing high capacity capture steps and single-use technologies. This study compares three mAb purification processes: a Protein A based process as a benchmark for comparing a high capacity ion exchange (column based) process and a process based on single-use technologies.
Michael Kuczewski, Scientist I, Percivia LLC
New, Unpublished Data
9:00
Case
Study
Development of an Alternative Monoclonal Antibody Polishing PlatformStudy
In this study Sartorius Sartobind® STIC was evaluated as a mAb polishing step. Utilizing a combination of HTS screening and DOE optimization, we developed a mAb polishing platform which demonstrated a high step recovery, and efficient clearance of impurities for multiple antibodies. This simple and efficient polishing step may shorten mAb purification processes, reduce production costs, and accelerate development programs.
Yun (Kenneth) Kang, Ph.D., Senior Scientist, Head of Purification Team, Bioprocess Sciences, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
New, Unpublished Data
9:30
Case
Study
Integration of Disposable Technologies to Enable Downstream Purification of High Titer Processes in Existing Manufacturing FacilitiesStudy
Recently we faced the challenge of transferring 3 new processes into our facility in Portsmouth, NH which each had higher titer processes than the facility was designed for. New capital investments are typically required to handle higher titers and the consequently higher process / buffer volumes in the purification suites. The choices we faced with respect to capital investments (fixed system vs. disposables), the selection criteria employed, and lessons learned will be presented.
Robert Grassi, Group Manager, Lonza Biologics
10:00
Networking Refreshment Break
New, Unpublished Data
10:30
A 'Fully' Disposable Primary Recovery Step for Harvesting Mammalian Cell Culture Systems: Focus of Depth Filtration technologies
The advent of highly productive cell-culture processes for the production of recombinant proteins has driven smaller batch processing that provides opportunity for transforming conventional bioprocess trains into single-use operations. We will be discussing the implementation of a 'fully' disposable primary recovery step using Depth filtration technologies for harvesting recombinant proteins from high cell density cell cultures containing mammalian cells. We will provide a technical overview of conventional Depth filtration performance capabilities and novel processing techniques including the pros and cons for implementing these clarification technologies.
Jonathan Romero, Ph.D., Senior Engineer, Biopharmaceutical Development, Biogen Idec
The advent of highly productive cell-culture processes for the production of recombinant proteins has driven smaller batch processing that provides opportunity for transforming conventional bioprocess trains into single-use operations. We will be discussing the implementation of a 'fully' disposable primary recovery step using Depth filtration technologies for harvesting recombinant proteins from high cell density cell cultures containing mammalian cells. We will provide a technical overview of conventional Depth filtration performance capabilities and novel processing techniques including the pros and cons for implementing these clarification technologies.
Jonathan Romero, Ph.D., Senior Engineer, Biopharmaceutical Development, Biogen Idec
11:00
Implementation of Disposable Depth Filtration Solutions for GLP and GMP Applications
Implementation of disposable depth filtration solutions improve facility flexibility, reduce project timelines, and reduce costs which are all critical factors in the contract manufacturing environment. Currently, multiple formats from different vendors cover small scale development through commercial manufacture, allowing for linear scale up from small scale development, and promoting maximum flexibility while minimizing capital investments.
Beth McCooey, Senior Manufacturing Scientist, PacificGMP
Implementation of disposable depth filtration solutions improve facility flexibility, reduce project timelines, and reduce costs which are all critical factors in the contract manufacturing environment. Currently, multiple formats from different vendors cover small scale development through commercial manufacture, allowing for linear scale up from small scale development, and promoting maximum flexibility while minimizing capital investments.
Beth McCooey, Senior Manufacturing Scientist, PacificGMP
11:30
Facility Debottlenecking through the Use of Simplified Buffer Systems for Antibody Manufacturing Process
Abstract unavailable at press date. Please visit www.IBCLifeSciences.com/BMD for program updates.
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
Abstract unavailable at press date. Please visit www.IBCLifeSciences.com/BMD for program updates.
Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center
12:00
Close of BMD Summit
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