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Single-Use Applications for Biopharmaceutical Manufacturing
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Agenda
7:30
Registration and Morning Coffee
8:30
Chairman's Opening Remarks
Stephen T. Brown, Ph.D., Chief Technical Officer, Vivalis, France
Stephen T. Brown, Ph.D., Chief Technical Officer, Vivalis, France
Keynote Addresses
8:45
Deploying Single-Use Applications from Process Development to CommercializationJoseph Coffey, Chief Commercial Officer, Gallus BioPharmaceuticals
9:15
Impact of Extractables and Leachables on Cell CultureSally Kline, Ph.D., Director, Materials Science, Amgen, Inc.
Update on Extractables & Leachables Standardization
9:45
EExtractable Protocol and Vendor Expectation Document Standardization Efforts from BPOG Working Group
Two standardization efforts at BPOG: Extractable Protocol Standardization and Vendor Expectation Document (VED). The VED is a new initiative designed to align all vendors to provide a standard set of data for their single-use products to customers. The goal of extractable protocol standardization is to ensure consistent extractable studies from vendors. Rationales for recommendations are also discussed.
Ken M. Wong, MSc., Senior Scientist, Specialty Analytical & Informatics, Merck & Co.
Two standardization efforts at BPOG: Extractable Protocol Standardization and Vendor Expectation Document (VED). The VED is a new initiative designed to align all vendors to provide a standard set of data for their single-use products to customers. The goal of extractable protocol standardization is to ensure consistent extractable studies from vendors. Rationales for recommendations are also discussed.
Ken M. Wong, MSc., Senior Scientist, Specialty Analytical & Informatics, Merck & Co.
10:15
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
QbD, Technical Diligence and Scale-Down Modeling
11:00
Implementation and Technical Diligence
The implementation of single-use technology (SUT) is addressed from a quality by design (QbD) perspective. The starting materials (resins and films) should be treated as critical raw materials and subject to careful verification as should the equipment and suppliers. Technical diligence provides a practical approach for the technical evaluation of a single-use system; its supplier and manufacturing process and its suitability for use, all performed as precursors to, or at the start of, the quality audit process. A practical case history of our experience in performing the technical diligent process is reviewed.
Stephen T. Brown, Ph.D., Chief Technical Officer, Vivalis, France
The implementation of single-use technology (SUT) is addressed from a quality by design (QbD) perspective. The starting materials (resins and films) should be treated as critical raw materials and subject to careful verification as should the equipment and suppliers. Technical diligence provides a practical approach for the technical evaluation of a single-use system; its supplier and manufacturing process and its suitability for use, all performed as precursors to, or at the start of, the quality audit process. A practical case history of our experience in performing the technical diligent process is reviewed.
Stephen T. Brown, Ph.D., Chief Technical Officer, Vivalis, France
11:30
How to Get More Out of Less: Impact and Benefits of Using QbD, DOE and Scale-Down Modeling to Establish Your Process Design Space
With the biotech industry facing increased competition, tighter funding and consolidation pressures, extracting more process understanding and knowledge from better designed experiments can help increase productivities, yields and manufacturing scalability. This "working smarter not harder" approach of Quality by Design (QbD) principles using Design of Experiment (DOE) and scale-down modeling tools can help establish (at the bench) a much more robust manufacturing process and design space, reveal process weaknesses and better predict process scalability and validatability. The presentation begins with a brief intro and update on the regulatory history/outlook of the QbD approach, followed by description of specific scale-down techniques, DOE experimental design and examples of process improvements and scalability achieved.
Parrish Galliher, Ph.D., Founder & Chief Technology Officer, Xcellerex, GE Healthcare Life Sciences
With the biotech industry facing increased competition, tighter funding and consolidation pressures, extracting more process understanding and knowledge from better designed experiments can help increase productivities, yields and manufacturing scalability. This "working smarter not harder" approach of Quality by Design (QbD) principles using Design of Experiment (DOE) and scale-down modeling tools can help establish (at the bench) a much more robust manufacturing process and design space, reveal process weaknesses and better predict process scalability and validatability. The presentation begins with a brief intro and update on the regulatory history/outlook of the QbD approach, followed by description of specific scale-down techniques, DOE experimental design and examples of process improvements and scalability achieved.
Parrish Galliher, Ph.D., Founder & Chief Technology Officer, Xcellerex, GE Healthcare Life Sciences
Technology Workshop
12:00
Single-use technologies got accepted amazingly fast for the production of clinical material. In this talk we'll focus on concepts which use single-use technologies and autonomous manufacturing environments for pilot and commercial production, allowing manufacturers to answer to changing market demands in a flexible way.
Christian Manzke, Director of Sales & Marketing, Integrated Solutions, Sartorius-Stedim Biotech GmbH
12:30
Networking Luncheon in Poster & Exhibit Hall
Integrated, Flexible, Modular SU Facilities
2:00
Case
Study
Flexible Responsive Clinical Supply FacilityStudy
Using single-use technologies throughout the process train gives rise to a cost-effective and state-of-the-art GMP bioproduction unit, delivering flexibility and allowing the user to accommodate process and capacity changes. In this talk we look at how the latest single-use technologies have delivered a flexible scaleable clinical supply unit that is not only cost effective, but also is sustainable when compared to the reusable alternatives. The project was initiated in late 2008 and is operational; we are able to quantify these benefits in terms of actual performance.
Matthieu Cullie, Head of Realisation of the Clinical Batches, Centre d'Immunologie Pierre Fabre, France
Andrew Sinclair, Ph.D., Managing Director, Biopharm Services Limited, United Kingdom
2:30
Hybrid SU Facilities - Optimizing Existing SS Facilities and Applying SU Where It Makes the Most Sense
Abstract not available at press time.
Brent Schreiber, Manager, Manufacturing Support, Bristol-Myers Squibb
Abstract not available at press time.
Brent Schreiber, Manager, Manufacturing Support, Bristol-Myers Squibb
3:00
Single-Use Process Fit for mAb Production
A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.
Jeffrey Johnson, MS, New Technology Lead, Merck & Co
A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.
Jeffrey Johnson, MS, New Technology Lead, Merck & Co
3:30
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
Continuous Processing
Chairman: Marc Bisschops, Ph.D., Chief Scientific Officer, Tarpon Biosystems, Inc.
4:15
Single-Use, Continuous Downstream Processing: The Next Great Efficiency Leap in Biopharmaceutical Manufacturing
Almost all mature process industries have embraced continuous manufacturing as a way to improve efficiency and gain better control over product quality. Over the past decade, these topics have also become increasingly important for biopharmaceutical processing. This presentation addresses recent developments which now allow single-use, continuous processing to become a reality; the potential benefits, the barriers and regulatory aspects of continuous processing in the biopharmaceutical industry.
Marc Bisschops, Ph.D., Chief Scientific Officer, Tarpon Biosystems
Almost all mature process industries have embraced continuous manufacturing as a way to improve efficiency and gain better control over product quality. Over the past decade, these topics have also become increasingly important for biopharmaceutical processing. This presentation addresses recent developments which now allow single-use, continuous processing to become a reality; the potential benefits, the barriers and regulatory aspects of continuous processing in the biopharmaceutical industry.
Marc Bisschops, Ph.D., Chief Scientific Officer, Tarpon Biosystems
Technology Workshop
4:45
Vaccines are becoming increasingly important to prevention a large number of diseases. For its production, a variety of expression systems are used from microbial to animal cells. However, many vaccines are still produced using traditional manufacturing technologies. This presentation will focus on modern single use cell culture (WAVE) and purification (ReadyToProcess™) strategies for production of virus-based vaccines. Also, the performance of a platform for propagation and purification of whole virus particles based on a number of robust and scalable cell culture, filtration, and chromatography techniques will be presented.
Stefan Soder, Marketing Segment Leader for Vaccine, GE Healthcare
5:15
Using Sequential Multi-Column Chromatography and Continuous Processing as a Solution to Purification Bottleneck
Improvements in upstream processes result in high titers hindering downstream processing efficiency. Sequential multi-column chromatography (SMCC) is a bottleneck-solution that streamlines purification efficiency. This presentation features a case study performed at Seattle Genetics, involving a high-titer monoclonal antibody process that was converted from Protein A batch to a sequential four-column operation that provided significant benefits.
Ruby Leah Casareno, Ph.D., Principal Scientist, BioProcess Development, Seattle Genetics, Inc.
Improvements in upstream processes result in high titers hindering downstream processing efficiency. Sequential multi-column chromatography (SMCC) is a bottleneck-solution that streamlines purification efficiency. This presentation features a case study performed at Seattle Genetics, involving a high-titer monoclonal antibody process that was converted from Protein A batch to a sequential four-column operation that provided significant benefits.
Ruby Leah Casareno, Ph.D., Principal Scientist, BioProcess Development, Seattle Genetics, Inc.
5:45
Wine & Cheese Reception in Poster & Exhibit Hall
7:30
Morning Coffee
8:00
Chairman's Opening Remarks
Andrew Sinclair, Ph.D., Managing Director, Biopharm Services Limited, United Kingdom
Andrew Sinclair, Ph.D., Managing Director, Biopharm Services Limited, United Kingdom
Debottlenecking Downstream Processing - Innovative Solutions to Traditional Chromatography, TFF and Centrifugation
8:15
Implementing Disposable Chromatography: Overcoming Challenges in Downstream Processing
Many of the world's leading biopharmaceutical companies have adopted single-use and disposable technologies for faster product changeover, favorable economics and improved safety. Adoption of disposable chromatography technology, however, has been limited. In this presentation, industry best practices for implementing disposable chromatography are discussed using a multi-cycle purification case study.
Stephen Tingley, Vice President Bioprocessing, Repligen Corporation
Many of the world's leading biopharmaceutical companies have adopted single-use and disposable technologies for faster product changeover, favorable economics and improved safety. Adoption of disposable chromatography technology, however, has been limited. In this presentation, industry best practices for implementing disposable chromatography are discussed using a multi-cycle purification case study.
Stephen Tingley, Vice President Bioprocessing, Repligen Corporation
8:45
Natrix: an Alternative to Traditional Chromatography
Natrix Separations produces a fully disposable, novel polymeric hydrogel formed within a flexible porous support matrix for use in the purification of biotherapeutics. Data using two of the Natrix products is presented:
Natrix Separations produces a fully disposable, novel polymeric hydrogel formed within a flexible porous support matrix for use in the purification of biotherapeutics. Data using two of the Natrix products is presented:
- A CEX hydrogel for capture of an IgG directly from clarified harvest.
- An AEX hydrogel for DNA and HCP removal. Recovery, capacity, impurity reduction and cost are discussed.
9:15
Case
Study
Single-Use Tangential Flow Filtration for Biopharmaceutical ApplicationsStudy
Tangential Flow Filtration (TFF) is a common processing step in downstream processing for concentration and diafiltration (buffer exchange) of biopharmaceutical products. Utilizing a single-use approach for TFF can reduce labor by 50% or more and reduce buffer and water usage by 75% or more. Novasep offers the first pre-sanitized, purpose built, single-use tangential flow filtration cassette for use in biopharmaceutical applications. Each SIUSTM TFF cassette is delivered pre-sanitized, ready to be equilibrated with buffer and used for processing. This presentation explores case studies for single-use TFF in biopharmaceutical applications.
Michael LaBreck, Global Product Manager, Novasep
9:45
Single-Use Platform: Fujifilm Diosynth Downstream Case Study-Implementation Challenges in Manufacturing for Accelerated Operational Flexibility
This presentation explores the investment and deployment of a single-use platform from vial-crack (start of the run) to aseptic bulk fill technology by Fujifilm Diosynth Biotechnologies, Inc. USA (FDBU) for manufacturing potent and non-potent molecules at various stages of drug development. The talk also discusses technical challenges in terms of size limitations, the new platform, ambiguity of new technology and regulatory challenges, which are all critical to designing a single-use technology platform solution.
Dhaval Tapiawala, Senior Engineer, Process Sciences, FUJIFILM Diosynth Biotechnologies U.S.A. Inc.
This presentation explores the investment and deployment of a single-use platform from vial-crack (start of the run) to aseptic bulk fill technology by Fujifilm Diosynth Biotechnologies, Inc. USA (FDBU) for manufacturing potent and non-potent molecules at various stages of drug development. The talk also discusses technical challenges in terms of size limitations, the new platform, ambiguity of new technology and regulatory challenges, which are all critical to designing a single-use technology platform solution.
Dhaval Tapiawala, Senior Engineer, Process Sciences, FUJIFILM Diosynth Biotechnologies U.S.A. Inc.
10:15
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
10:45
Single-Use Hybrid Purifier - A New Purification Platform Integrating Hydrogel Chromatography and Size Exclusion Membrane into a Scalable Device Format
Integration of multiple purification functionalities into a single-use device provides the opportunity to improve downstream process efficiency and reduce overall cost-of-goods. A new system-responsive composite synthetic purification media, integrating a hydrogel anion exchange chromatography and size exclusion membrane, is described. Performance of Protein A chromatography with various regeneration protocols, a product purity and protein aggregate formation post viral inactivation are presented.
Angelines Castro Forero, Ph.D., Product Development Bioengineer, Life Sciences Process Technologies, 3M
Integration of multiple purification functionalities into a single-use device provides the opportunity to improve downstream process efficiency and reduce overall cost-of-goods. A new system-responsive composite synthetic purification media, integrating a hydrogel anion exchange chromatography and size exclusion membrane, is described. Performance of Protein A chromatography with various regeneration protocols, a product purity and protein aggregate formation post viral inactivation are presented.
Angelines Castro Forero, Ph.D., Product Development Bioengineer, Life Sciences Process Technologies, 3M
11:15
Design Considerations for Single-Use Tangential Flow Filtration (TFF) Systems for Efficient UF/DF Performance
Protein concentration/diafiltration is typically performed at the tail-end of the purification process. This requires that the system used at this step is designed for optimal process performance and high product recovery. The presentation focuses on optimal tank design for the retentate recycle tank as well as a novel single-use flow path design, which enable efficient performance of protein concentration/diafiltration operation.
David Bohonak, Ph.D., Senior Applications Engineer, EMD Millipore
Protein concentration/diafiltration is typically performed at the tail-end of the purification process. This requires that the system used at this step is designed for optimal process performance and high product recovery. The presentation focuses on optimal tank design for the retentate recycle tank as well as a novel single-use flow path design, which enable efficient performance of protein concentration/diafiltration operation.
David Bohonak, Ph.D., Senior Applications Engineer, EMD Millipore
Disposable Probes and Sensors - State of the Industry
11:45
Building Flexibility into Bio-Processing: Turn-Key Bioreactor Control Systems for Both cGMP and Non-GMP Applications
Multi-purpose controllers make it possible to swap out vessels from different vendors or different size vessels from the same vendor. Universal controllers can be used for glass, single-use (up to 2000L) or rockers. Single-use sensor technology, plug-and-play integration and better technology transfer capability for integration into flexible systems are illustrated in this presentation.
Alan Opper, Eastern Regional Manager, Finesse Solutions
Multi-purpose controllers make it possible to swap out vessels from different vendors or different size vessels from the same vendor. Universal controllers can be used for glass, single-use (up to 2000L) or rockers. Single-use sensor technology, plug-and-play integration and better technology transfer capability for integration into flexible systems are illustrated in this presentation.
Alan Opper, Eastern Regional Manager, Finesse Solutions
12:15
A Comparative Study of Stirred-Tank Bioreactors: Reusable (Glass) vs. Single-Use (New Brunswick CelliGen® BLU)
This presentation examines multiple comparisons with New Brunswick's CelliGen® BLU single-use bioreactors (including the packed-bed version) and traditional glass vessel counterparts. It includes an economic analysis of CelliGen BLU vs. traditional glass vessels and data from alkaline phosphatase (ALKP)-secreting CHO cells that were used to measure ALKP production in each bioreactor.
Kamal Rashid, Ph.D., Associate Director, Research Professor, Utah State University
This presentation examines multiple comparisons with New Brunswick's CelliGen® BLU single-use bioreactors (including the packed-bed version) and traditional glass vessel counterparts. It includes an economic analysis of CelliGen BLU vs. traditional glass vessels and data from alkaline phosphatase (ALKP)-secreting CHO cells that were used to measure ALKP production in each bioreactor.
Kamal Rashid, Ph.D., Associate Director, Research Professor, Utah State University
12:45
Networking Luncheon in Poster & Exhibit Hall
Single-Use Applications in Vaccine Production Shared Session with IBC's Vaccine Development and Production Summit
Session Sponsor:
1:50
Chairman's Opening Remarks
Ian Sellick, Director of Marketing, Pall Life Sciences
Ian Sellick, Director of Marketing, Pall Life Sciences
Featured Presentation
2:00
Case
Study
Implementation of SU Technology for Production of UK Anthrax VaccineStudy
The UK-licensed anthrax vaccine, Anthrax Vaccine Precipitated (AVP), has been produced using the same process for a number of years. We are evaluating the application of single-use technology to modernize the process. Data is presented to assess the comparability of AVP produced using modernized compared to traditional methods, in terms of both vaccine composition and immunogenicity.
Kelly Lowings, Ph.D., Senior Scientist, Vaccine Research Group, Public Health England, United Kingdom
2:30
Vaccine Manufacturing Technologies Suitable for New Manufacturers in Emerging Markets
Vaccine manufacturers in emerging markets are traditionally producing high-volume, low-cost vaccines. Often, small countries in emerging markets aspire to manufacture vaccines internally and attain self-sufficiency. This presentation explores the cost and time efficient technologies required to produce multiple products. It also covers flexible manufacturing platforms and solutions that comprehensively address cost-effective requirements. The talk also covers how the combination of modular vaccine manufacturing facilities, high throughput processes and disposable technologies can redefine the way vaccines are manufactured.
Sreenivasa Reddy Guddeti, B.V.Sc., Chief General Manager, Indian Immunologicals Limited, India
Vaccine manufacturers in emerging markets are traditionally producing high-volume, low-cost vaccines. Often, small countries in emerging markets aspire to manufacture vaccines internally and attain self-sufficiency. This presentation explores the cost and time efficient technologies required to produce multiple products. It also covers flexible manufacturing platforms and solutions that comprehensively address cost-effective requirements. The talk also covers how the combination of modular vaccine manufacturing facilities, high throughput processes and disposable technologies can redefine the way vaccines are manufactured.
Sreenivasa Reddy Guddeti, B.V.Sc., Chief General Manager, Indian Immunologicals Limited, India
3:00
Recombinant Protein Vaccines Produced in Insect Cells
The baculovirus-insect cell expression system is used in the manufacturing of various vaccines. The key advantage of this recombinant protein manufacturing platform is its universal "plug and play" process for the production of a broad range of protein-based products. This presentation explores this production platform and provides an overview of products that it yields.
Valerie Mermall, Ph.D., Director, Quality Control, Protein Sciences Corporation
The baculovirus-insect cell expression system is used in the manufacturing of various vaccines. The key advantage of this recombinant protein manufacturing platform is its universal "plug and play" process for the production of a broad range of protein-based products. This presentation explores this production platform and provides an overview of products that it yields.
Valerie Mermall, Ph.D., Director, Quality Control, Protein Sciences Corporation
3:30
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
4:00
Design and Deployment Strategy for Single-Use Component Assemblies
Single-use technologies can help reduce manufacturing costs, improve start-up times, and facilitate the introduction of vaccines to new markets. These benefits are lost if certain practical considerations are not addressed during process design. Connectivity of unit operations, standardization of parts, and simplification of inventories are all keys to success with single-use technology. This talk presents general principles for single-use system design for upstream, downstream, or filling operations in sterile pharmaceutical, vaccine, and biologics manufacturing.
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
Single-use technologies can help reduce manufacturing costs, improve start-up times, and facilitate the introduction of vaccines to new markets. These benefits are lost if certain practical considerations are not addressed during process design. Connectivity of unit operations, standardization of parts, and simplification of inventories are all keys to success with single-use technology. This talk presents general principles for single-use system design for upstream, downstream, or filling operations in sterile pharmaceutical, vaccine, and biologics manufacturing.
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
Technology Rapid-Fire Showcase
4:30
Plug and play single-use filtration solutions deliver processing convenience for biopharmaceutical manufacturers. Innovative filtration media and multi-stage filtration train designs provide truly scalable performance from PD to production. Unique, integrated sensor connectivity supports process monitoring functionality while associated support products provide for robust, repeatable, deployment of large scale filtration solutions.
Max Blomberg, Director of Operations, Meissner Filtration Products
5:30
Close of Day Two
Site Tour
5:15
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Fujifilm Diosynth Biotechnologies, a full-service Biologics Contract Development and Manufacturing Organization in Morrisville, North Carolina, invites you to tour its recently expanded Single-Use manufacturing facility in Research Triangle Park, NC! Along with its Billingham, UK, facility, these sites offer more than 25 years of combined experience in the development and manufacture of recombinant proteins, vaccines and monoclonal antibodies, expressed in a wide array of microbial, mammalian and insect cell systems. Transportation is provided, but space is limited and available on a first-come, first-served basis. There is no additional fee, but pre-registration is required.
Fujifilm Diosynth Biotechnologies, a full-service Biologics Contract Development and Manufacturing Organization in Morrisville, North Carolina, invites you to tour its recently expanded Single-Use manufacturing facility in Research Triangle Park, NC! Along with its Billingham, UK, facility, these sites offer more than 25 years of combined experience in the development and manufacture of recombinant proteins, vaccines and monoclonal antibodies, expressed in a wide array of microbial, mammalian and insect cell systems. Transportation is provided, but space is limited and available on a first-come, first-served basis. There is no additional fee, but pre-registration is required.
8:00
Morning Coffee
8:30
Chairman's Opening Remarks
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Single-Use Applications in Fill/Finish
8:45
Challenges of Implementing Single-Use Systems into Existing Commercial Manufacturing Facilities
Single-Use Technologies are rapidly gaining a foothold in several aspects global Biopharmaceutical manufacturing. Although upstream applications are more commonplace; several new technologies are becoming available forformulation, fill and finish production facilities. Challenges from a validation and regulatory perspective as well as potential facility capacity and cost savings benefits are discussed.
Kevin O'Connor, Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Single-Use Technologies are rapidly gaining a foothold in several aspects global Biopharmaceutical manufacturing. Although upstream applications are more commonplace; several new technologies are becoming available forformulation, fill and finish production facilities. Challenges from a validation and regulatory perspective as well as potential facility capacity and cost savings benefits are discussed.
Kevin O'Connor, Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Audience Interactive Panel Discussion
9:15
Single-Use for Fill/Finish: The Next Frontier
Moderator:
Jessica Frantz, Field Marketing Manager, Aseptic Transfer System, Fluid Management Technologies, Sartorius-Stedim Biotech
Panelists:
James Barry, Global Marketing Manager, Single-Use Systems, Pall Life Sciences
Kevin O'Connor, Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
Moderator:
Jessica Frantz, Field Marketing Manager, Aseptic Transfer System, Fluid Management Technologies, Sartorius-Stedim Biotech
Panelists:
James Barry, Global Marketing Manager, Single-Use Systems, Pall Life Sciences
Kevin O'Connor, Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
10:15
Networking Refreshment Break in Poster & Exhibit Hall
Supply Chain and Reliability of SU Components
10:45
Managing Supply Chain and Process Risks from Single-Use Systems
This presentation discusses strategies for managing supply chain risks introduced by complex raw materials and single-use systems. SUS are frequently being used to replace traditional stainless steel manufacturing equipment and can often improve process turnover time and reduce costs from cleaning validation. However, to fully capture the value of SUS implementation and avoid supply chain disruptions, a risk management strategy applied to the SUS supply chain is essential.
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.
This presentation discusses strategies for managing supply chain risks introduced by complex raw materials and single-use systems. SUS are frequently being used to replace traditional stainless steel manufacturing equipment and can often improve process turnover time and reduce costs from cleaning validation. However, to fully capture the value of SUS implementation and avoid supply chain disruptions, a risk management strategy applied to the SUS supply chain is essential.
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.
11:15
Preventing Product Loss - Beyond Assembly Design
Single-use systems contain valuable drug product. End users rely on the design of the assembly to maintain a closed process around the drug product to prevent product loss. But what can an end user do to reduce the risk of product loss? In addition to examples of assembly design strategies, this discussion examines the effect of facility layout, human factors and environment in preventing product loss when implementing single-use systems.
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
Single-use systems contain valuable drug product. End users rely on the design of the assembly to maintain a closed process around the drug product to prevent product loss. But what can an end user do to reduce the risk of product loss? In addition to examples of assembly design strategies, this discussion examines the effect of facility layout, human factors and environment in preventing product loss when implementing single-use systems.
Russell Wong, Ph.D., Senior Process Development Engineer, Manufacturing Sciences, Bayer Healthcare
11:45
Close of Conference
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