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Single-Use Applications for Biopharmaceutical Manufacturing
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Event Information
Document Title
Agenda
CMOs, Start-Ups and Biosimilars: Lessons Learned from the Cutting Edge of Disposable Implementation
7:00
Registration and Networking Coffee
8:00
Chairperson's Opening Remarks
Peter Latham, President, BioPharm Services US
Peter Latham, President, BioPharm Services US
8:15
Case
Study
Design, Start-Up and Operation of Acceleron's New Single Use FacilityStudy
Disposable equipment creates the opportunity to design a new facility which is simple to design and build, cost effective, and easy to validate and run. The facility described in this presentation maximizes the use of disposable technology for fast and efficient production of early and late phase clinical material.
Robert J. Steininger II, Senior Vice President, Manufacturing, Acceleron Pharma
8:45
Use of Disposable Technology in the Context of Contract Manufacturing
Abstract unavailable at press date.
Blair Anger, Research Associate, Merck & Co., Inc.
Abstract unavailable at press date.
Blair Anger, Research Associate, Merck & Co., Inc.
9:15
Case
Study
Integration of Single-Use Technology into the Design of a Facility ExpansionStudy
This presentation will describe how single-use technology applications were considered in the design of a multiproduct facility expansion. The integration of single-use systems was driven by emerging technologies and prior clinical and commercial manufacturing experience, with emphasis placed on operational flexibility and efficiency.
Marisa Hewitt, Process Engineer II, Manufacturing Sciences, BioMarin Pharmaceutical
9:45
Networking Refreshment Break
Unpublished New Data
10:15
Case
Study
Teva's Use of Single-Use Technologies to Increase GMP Facility CapabilitiesStudy
Teva Biopharmaceuticals USA was faced with the challenge of manufacturing early to mid phase clinical material for multiple mammalian products in an existing stainless tank microbial facility, while maintaining the ability to manufacture microbial products. Single-use technologies were key to adding mammalian functionality without compromising the existing microbial systems.
Bob Burke, Senior Bioprocess Engineer, Teva Biopharmaceuticals USA
10:45
Case
Study
Analysis of Production Costs and Product Equivalency in Cell Culture Production Utilizing Stainless Steel versus Single Use Disposable Bioreactor TechnologyStudy
This case study provides a cost analysis demonstrating a reduction in labor and utilities required to perform a fed batch cell culture campaign. Comparable growth patterns and product expression will also be demonstrated from multiple 200L stainless and 600L SUB bioreactor campaigns.
Eric J. Nalbach, Senior Manager, Upstream Processing, Laureate Pharma, Inc.
Audience Interactive Panel Discussion
11:15
The Drivers for and against Disposable Implementation
The panel will further discuss and field questions on the factors that drove their decisions to implement (or not implement) disposables and how those drivers were evaluated. We will also address the implementation process and the level of organizational buy-in and push back that was required and faced through the process. This panel will provide valuable information for those considering disposable implementation with respect to evaluating the benefits and selling the concepts internally.
Moderator: Peter Latham, President, BioPharm Services US
Panelists: All Workshop Speakers
The panel will further discuss and field questions on the factors that drove their decisions to implement (or not implement) disposables and how those drivers were evaluated. We will also address the implementation process and the level of organizational buy-in and push back that was required and faced through the process. This panel will provide valuable information for those considering disposable implementation with respect to evaluating the benefits and selling the concepts internally.
Moderator: Peter Latham, President, BioPharm Services US
Panelists: All Workshop Speakers
11:45
End of Workshop; Lunch on your own
Registration for Main Conference
Registration for Main Conference
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
1:10
Chairperson's Remarks
Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
Keynote Presentation
1:15
Optimizing Biomanufacturing Architectures: Flexibility, Agility, and Real-Time Advantage for an Unpredictable FutureThe Texas A&M University System (TAMUS) has initiated two large scale biopharmaceutical manufacturing research and production facilities to demonstrate the concept of "flexible-by-design." TAMUS seeks to transform biomanufacturing by optimizing the facility architecture and maximizing the utility of single use bioprocess components in order to accommodate multiple clients, products, and technologies within a single facility. Combined with novel biomanufacturing platforms, single use technologies have the ability to have a profound impact on the future manufacture of commercial and defense-related biopharmaceuticals.
Brett P. Giroir, M.D., Vice Chancellor for Research, The Texas A&M University System
Qualification and Validation: Assessing Risk Factors
Featured Presentation
2:00
Review of Single Use Processes: Overview of Types of Data to Be Reviewed and Specific Areas of ConcernA wide range of information is submitted to CBER with respect to Single Use Processes and Materials. The speaker will highlight single use material issues noted over time, and discuss factors and information that should be considered when such materials are used for Biologic Drug manufacture.
LCDR Destry Sillivan, USPHS, Senior Regulatory Review Officer, CBER, FDA
2:30
BPSA Expanded Guide to Extractables from Single Use Systems
Qualification of extractables from single-use process equipment is a critical requirement for risk assessment of potential process-derived leachables in final product. Similarity of applications enables a common general approach. This presentation will describe the newly expanded BPSA guide to testing of extractables from single use equipment. Harmonizing of extraction conditions and analyses are provided which can facilitate generic data comparisons and minimize user testing requirements.
Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
Qualification of extractables from single-use process equipment is a critical requirement for risk assessment of potential process-derived leachables in final product. Similarity of applications enables a common general approach. This presentation will describe the newly expanded BPSA guide to testing of extractables from single use equipment. Harmonizing of extraction conditions and analyses are provided which can facilitate generic data comparisons and minimize user testing requirements.
Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
3:00
The PDA Technical Report on Qualification and Validation of Single Use Systems
Abstract unavailable at press date.
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare (invited)
Abstract unavailable at press date.
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare (invited)
3:30
Grand Opening of Poster and Exhibit Hall with Networking Refreshment Break
Audience Interactive Panel Discussion
4:00
Development and Application of Industry and Regulatory Recommendations for Single Use Systems
Moderator: Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
Panelists: All Qualification and Validation Session speakers
Moderator: Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Chairman, Bio-Process Systems Alliance
Panelists: All Qualification and Validation Session speakers
Unpublished New Data
4:30
Disposing of Disposables & Related Environmental Concerns
This presentation addresses environmental concerns related to use and disposal of Single Use components. The impact of manufacturing these components, the disposal methods for production waste, and calculations of their combined environmental impact are discussed. Suppliers and drug manufacturers are working together to establish methods of manufacturing and disposal which offer new opportunities to minimize environmental impact.
Wayne Flaherty, Principal Consultant/President, Compliance Concepts International
This presentation addresses environmental concerns related to use and disposal of Single Use components. The impact of manufacturing these components, the disposal methods for production waste, and calculations of their combined environmental impact are discussed. Suppliers and drug manufacturers are working together to establish methods of manufacturing and disposal which offer new opportunities to minimize environmental impact.
Wayne Flaherty, Principal Consultant/President, Compliance Concepts International
Technology Workshop
5:00
Capacity increases as well as restructuring of existing facilities in the biopharmaceutical industry require a reduction of cost of goods and a constant increase of operational flexibility. This presentation provides information about an approach to establish technology platforms based on unit operations which reflect current industry needs. It highlights advantages such as quick operational adjustment, increased flexibility, rapid availability for process conversion and optimized process scale up from R&D up to production.
Thomas Paust, Global Director of Marketing Integrated Solutions, Sartorius Stedim Biotech GmbH, Germany
5:30
Networking in Poster and Exhibit Hall
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
7:30
Networking Coffee
Disposable Sensors, Probes and Bioreactor Implementation
Session Sponsored by
8:00
Chairperson's Remarks
David A. Radspinner, Ph.D., Director of Marketing, Thermo Scientific Cell Culture & BioProcessing, Thermo Fisher Scientific
David A. Radspinner, Ph.D., Director of Marketing, Thermo Scientific Cell Culture & BioProcessing, Thermo Fisher Scientific
Unpublished New Data
8:15
Single-Use System Design Engineering Perspective on Selection of Commercially Available Single-Use Instrumentation
A next generation of single-use and non-intrusive instrumentation has become available for use in downstream bioprocessing systems. Since criticality of process analytical technologies varies with application, new instrumentation has been evaluated for a variety of criteria, including but not limited to, accuracy/repeatability, capital cost, renewable cost, ease of use and impact on system design.
Erik Storm, Single Use Systems Process Engineer/Project Manager, Pall Life Sciences
A next generation of single-use and non-intrusive instrumentation has become available for use in downstream bioprocessing systems. Since criticality of process analytical technologies varies with application, new instrumentation has been evaluated for a variety of criteria, including but not limited to, accuracy/repeatability, capital cost, renewable cost, ease of use and impact on system design.
Erik Storm, Single Use Systems Process Engineer/Project Manager, Pall Life Sciences
Unpublished New Data
8:45
Case
Study
Single-Use Sensors Evaluation for Single-Use Bioreactors: A Case Study with Microcarrier Cell Culture Process for Vaccines ApplicationStudy
In parallel of an evaluation of different kinds of stirred single-use bioreactors for cell culture, GSK Biologicals has tested single-use sensor technologies for DO and pH measurements. Single-use technologies have been compared to re-usable ones. This study includes numerous considerations like signal accuracy, drifting, (re-)calibration, and others. The presentation will highlight the results of the study and technical aspects.
Ludovic Peeters, Engineer, Industrialization, GlaxoSmithKline Biologicals, Belgium
9:15
Evaluation and Implementation of Cutting Edge Sensors
Gain insight from a comparison of traditional/reusable/autoclavable DO and pH sensors to single-use, pre-calibrated, irradiated sensors used within single use stirred bioreactors at a variety of scales. The driver for this work is to improve speed and ease of bioreactor turn-around time and other factors. Hear the advantages/disadvantages of single-use sensors, our traditional vs single-use performance data for pH and DO (in-line fermentation data for cell culture fed-batch processes) and the latest status of Lonza's cGMP implementation project.
David Valentine, Senior Scientist, Manufacturing Science and Technology, Lonza Biologics, United Kingdom
Gain insight from a comparison of traditional/reusable/autoclavable DO and pH sensors to single-use, pre-calibrated, irradiated sensors used within single use stirred bioreactors at a variety of scales. The driver for this work is to improve speed and ease of bioreactor turn-around time and other factors. Hear the advantages/disadvantages of single-use sensors, our traditional vs single-use performance data for pH and DO (in-line fermentation data for cell culture fed-batch processes) and the latest status of Lonza's cGMP implementation project.
David Valentine, Senior Scientist, Manufacturing Science and Technology, Lonza Biologics, United Kingdom
Unpublished New Data
9:45
Case
Study
Scaling up a Large Scale Disposable Vaccine Manufacturing Process: Microcarrier Culture, Facility and Economics ConsiderationsStudy
Hear the challenges and solutions that resulted in a fully disposable process scale-up to 500L serum-free process (NucleoPG-ATMI) achieving productivity comparable or superior to stainless steel bioreactors. Specifics of anchorage dependent cell lines for virus/vaccine production will be detailed. Studies including operational benefits and the integration of disposable elements across the process line will be presented.
Nicolas Seve, Process Development Engineer, Bioprocessing Research Department, Sanofi Pasteur, France
10:15
Networking Refreshment Break, Exhibit and Poster Viewing
11:00
Presentation Title TBA
Abstract unavailable at press date.
Speaker TBA
Abstract unavailable at press date.
Speaker TBA
Unpublished New Data
11:30
Case
Study
Hyclone Single Use Bioreactor Coupled to Finesse Hardware and DO Probe Evaluation for a Fed-Batch Production ProcessStudy
The presentation will describe the evaluation study done at MerckSerono on the Hyclone 50L SUB bioreactor coupled to Finesse's hardware and Software from the Seed train bioreactor to Production. The study was performed with a Fed Batch production process of a monoclonal antibody with CHO cells, usually produced at a 5L bioreactor scale. A comparison of Finesse's Trufluor DO single use probe and a stainless steel Mettler Toledo probe was also performed.
Emmanuelle Cameau, Biotechnology Engineer, Biotech Process Sciences (BPS) - Upstream Process, Merck Serono S.A., Switzerland
Technology Workshop
12:00
The CelliGen BLU is New Brunswick's newest offering in the bench-top bioreactor and fermentor family of products. Positioned as a novel system offering 5.0L or 14.0L stirred tank single-use vessels; this system mimics traditional autoclavable technology while providing all the benefits of disposable technology. The CelliGen BLU will meet the demands of the single-use system users not satisfied with the current bench scale single-use bioreactors available on the market.
Richard Mirro, Product Manager, New Brunswick Scientific
12:30
Networking Luncheon, Exhibit and Poster Viewing
Single Use Systems for Vaccine Production
Shared Session with Vaccine Production Summit
1:55
Chairperson's Opening Remarks
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, Medimmune Vaccines
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, Medimmune Vaccines
Keynote Presentation
2:00
Universal, Rapid Deployment, Single-Use Manufacturing: A Paradigm Shift for VaccinesVaccine manufacturing is undergoing a major shift. Recent successes demonstrate that rapid deployment, universal, single-use vaccine production is enabling developers to avoid traditional bottlenecks impacting quality, cost, time to first dose and supply. In addition, these successes have demonstrated the ability to accommodate mammalian, insect or microbial cultures that produce either subunit, live virus, attenuated virus, inactivated vaccines or VLPs including H1N1 swine flu vaccine. The paper will review recent cases involving the deployment of flexible vaccine manufacturing platforms.
Parrish M. Galliher, Founder and Chief Technology Officer, Xcellerex, Inc.
Audience Interactive Panel Discussion
2:45
Disposable processing technologies have enabled new approaches to manufacturing. Larger disposable upstream bioreactors and fully disposable downstream processing made possible with multi-column continuous chromatography enable a self contained manufacturing platform. The panel will discuss this fully disposable and deployable bioprocess train.
Moderator: Peter Latham, President, BioPharm Services US
Panelists:
Parrish M. Gallliher, Founder and Chief Technology Officer, Xcellerex, Inc.
Richard A. Richieri, Senior Vice President, Manufacturing/BioProcess Development, Avid Bioservices, Inc.
Additional panelists to be announced
3:30
Networking Refreshment BreakLast Chance for Exhibit & Poster Viewing
Technology Workshop
4:00
GE Healthcare has now integrated all the features of disposable processing into ReadyCircuits; a new platform of disposable components that are combined to create self contained process modules as basic as buffer filtration or as complex as a complete TFF operation. This workshop outlines the ReadyCircuit portfolio, shows examples of how easily circuits can be designed, and how quickly one can configure a circuit through a new on- line configurator.
Karen Green, Senior Product Manager, GE Healthcare
4:30
Optimizing Single Use Cell Harvest Technologies for Vaccine Production
Current bioprocessing technologies have limited applications in vaccine and cell therapy manufacturing as they are typically optimized for the manufacture of recombinant proteins. Most cell harvest technologies aim at efficiently removing cells but not at maximizing viable cell density, viability, and recovery; parameters that are critical for vaccine and cell therapy manufacturing. This presentation outlines a next generation single use cell harvest technology that supports the specific requirements of vaccine production applications.
Sunil Mehta, B.Pharm, Ph.D., Director, Technology Development, KBI Biopharma Inc.
Current bioprocessing technologies have limited applications in vaccine and cell therapy manufacturing as they are typically optimized for the manufacture of recombinant proteins. Most cell harvest technologies aim at efficiently removing cells but not at maximizing viable cell density, viability, and recovery; parameters that are critical for vaccine and cell therapy manufacturing. This presentation outlines a next generation single use cell harvest technology that supports the specific requirements of vaccine production applications.
Sunil Mehta, B.Pharm, Ph.D., Director, Technology Development, KBI Biopharma Inc.
Unpublished New Data
5:00
Disposable Bioreactors for Viral Vaccine Production: Challenges and Opportunities
The implementation of disposable bioreactors has been quite successful for the production of recombinant proteins and monoclonal antibodies. This presentation will focus on the specificities of viral vaccine upstream processes (micro-carriers culture) and will highlight GSK Biologicals' methodology to implement such devices in industrial processes. Comparison with current stainless steel process will be discussed including Cost Of Goods and biosafety.
Jean-François Chaubard, Director, Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
The implementation of disposable bioreactors has been quite successful for the production of recombinant proteins and monoclonal antibodies. This presentation will focus on the specificities of viral vaccine upstream processes (micro-carriers culture) and will highlight GSK Biologicals' methodology to implement such devices in industrial processes. Comparison with current stainless steel process will be discussed including Cost Of Goods and biosafety.
Jean-François Chaubard, Director, Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
5:30
Sensors for Disposable Bioreactors and Integration with PAT/QbD
Abstract unavailable at press date.
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, MedImmune Vaccines
Abstract unavailable at press date.
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, MedImmune Vaccines
6:00
Close of Tuesday Sessions
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
7:30
Networking Coffee
Latest Disposable Technologies in Downstream Processing
8:00
Chairperson's Remarks
Adam Goldstein, Senior Manager, Clinical Operations, Genentech, Inc.
Adam Goldstein, Senior Manager, Clinical Operations, Genentech, Inc.
Unpublished New Data
8:15
Pall STAX Disposable Depth Filter Implementation at Pilot Scale
The Pall STAX is a disposable depth filter platform with a small footprint and flexible filtration capacity. This system was evaluated at pilot scale to replace traditional lenticular filters in order to improve process performance and reliability, improve safety and ergonomics, and reduce labor associated with cleaning traditional housings.
Beth McCooey, Engineer, Genentech, Inc.
The Pall STAX is a disposable depth filter platform with a small footprint and flexible filtration capacity. This system was evaluated at pilot scale to replace traditional lenticular filters in order to improve process performance and reliability, improve safety and ergonomics, and reduce labor associated with cleaning traditional housings.
Beth McCooey, Engineer, Genentech, Inc.
Unpublished New Data
8:45
A Single Use Purification Platform for Monoclonal Antibodies
Advances in single-use technologies can enable greater speed, flexibility, and a smaller footprint for multi-product facilities. In a disposable scheme, traditional column operations are replaced with adsorptive membranes or other non-traditional separations. Here, we present a series of single use harvest and purification steps including a proprietary settling technique (ECS™), precipitation, and membrane adsorbers that result in comparable product quality and yield to traditional processes.
Michael Kuczewski, Scientist I, Downstream Process Development, PERCIVIA, LLC
Advances in single-use technologies can enable greater speed, flexibility, and a smaller footprint for multi-product facilities. In a disposable scheme, traditional column operations are replaced with adsorptive membranes or other non-traditional separations. Here, we present a series of single use harvest and purification steps including a proprietary settling technique (ECS™), precipitation, and membrane adsorbers that result in comparable product quality and yield to traditional processes.
Michael Kuczewski, Scientist I, Downstream Process Development, PERCIVIA, LLC
Unpublished New Data
9:15
Case
Study
Design, Development and Implementation of Disposable Tangential-Flow Filtration System for Use at GenentechStudy
Development of Antibody-Drug Conjugates (ADC's) is a new, promising technology in Genentech's fight against cancer. The small molecules attached to the antibody are toxic in their free-form. We have developed a single-use TFF system to remove free drug which eliminates the need for cleaning and changeover, minimizing exposure risk to the operator. We were able to go from concept through SAT in 5 months..
Ryan Hutchinson, Engineer, Process Development Engineering, Genentech, Inc.
Technology Workshop
9:45
Dedicated to developing innovative disposable devices, automated systems and services, Pall Life Sciences introduces several key products that answer end user needs and requirements. A demonstration of economic modeling and its application to integrated single-use manufacturing, new devices for sterile interactions as well as automated system design per unit operation will be provided.
Christopher J. Mach, Global Product and Marketing Manager, Allegro Single Use Systems, Pall Life Sciences
10:15
Networking Refreshment Break
Unpublished New Data
10:45
Single-Use Pre-Packed Columns, Different Needs Compared to Plastic Bags.
Defining a need either for a real single use and immediate disposal or repeated use of a one-time packed column is of importance for the design and resulting costs. Whereas the leachables and extractables evaluation concerns both of them, chromatographic columns need to be subjected to sophisticated transport validation studies to evidence the quality of the packing is still within the specification set for theoretical plates and peak asymmetry. Several aspects of pre-packed column validation are discussed.
Juergen Friedle, Ph.D., Senior Vice President, Atoll GmbH, Germany
Defining a need either for a real single use and immediate disposal or repeated use of a one-time packed column is of importance for the design and resulting costs. Whereas the leachables and extractables evaluation concerns both of them, chromatographic columns need to be subjected to sophisticated transport validation studies to evidence the quality of the packing is still within the specification set for theoretical plates and peak asymmetry. Several aspects of pre-packed column validation are discussed.
Juergen Friedle, Ph.D., Senior Vice President, Atoll GmbH, Germany
11:15
Applicability of Pre-Packed Columns
The presentation will identify in which processes the columns are considered to be the best choice. The use of pre-packed columns will also be analyzed from a cost perspective and how the columns could be used to change down time to up time. Finally hear an example of quality aspects to consider when a part of the downstream process, e.g. column packing and testing, are transferred from the user to the producer.
Kristoffer Rudenholm Hansson, MSc, Manager, Cell Culture Purification, CMC Biologics A/S, Denmark
The presentation will identify in which processes the columns are considered to be the best choice. The use of pre-packed columns will also be analyzed from a cost perspective and how the columns could be used to change down time to up time. Finally hear an example of quality aspects to consider when a part of the downstream process, e.g. column packing and testing, are transferred from the user to the producer.
Kristoffer Rudenholm Hansson, MSc, Manager, Cell Culture Purification, CMC Biologics A/S, Denmark
11:45
Utilizing RFID to Identify Bioprocess Containers and Monitor Batch-Related Data
Advancements in wireless identification technology targeted to the needs of biopharmaceutical manufacturers using single-use processes provides totally paperless traceability and facilitates quick retrieval of batch-related information to fulfill the growing demands of regulatory agencies and validation inspectors. In this discussion, the implementation of RFID (Radio Frequency Identification) in the process and manufacturing end of the biopharmaceutical industry utilizing single-use bioprocess containers will be explored.
Jeffrey D. Johnson, Director, Software Solutions, AdvantaPure/NewAge Industries
Advancements in wireless identification technology targeted to the needs of biopharmaceutical manufacturers using single-use processes provides totally paperless traceability and facilitates quick retrieval of batch-related information to fulfill the growing demands of regulatory agencies and validation inspectors. In this discussion, the implementation of RFID (Radio Frequency Identification) in the process and manufacturing end of the biopharmaceutical industry utilizing single-use bioprocess containers will be explored.
Jeffrey D. Johnson, Director, Software Solutions, AdvantaPure/NewAge Industries
12:15
Close of Single Use Applications Conference
Delegates may join the afternoon session of the Vaccine Production Summit.
Delegates may join the afternoon session of the Vaccine Production Summit.
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