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Single-Use Applications for Biopharmaceutical Manufacturing
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» Download the Full Conference Brochure for Presentation Abstracts
Monday | Tuesday | Wednesday
For full presentation abstracts, download the conference brochure
7:30
Registration and Networking Coffee
Leachables & Extractables
8:15
Chairperson's Opening Remarks
Parrish Galliher, M.S., Founder and Chief Technology Officer, Xcellerex, Inc.
Parrish Galliher, M.S., Founder and Chief Technology Officer, Xcellerex, Inc.
8:30
Sponsored by
Managing the Risks of Leachables from Polymeric Single-Use Processing EquipmentPerforming a proactive materials assessment for the polymers used to fabricate single-use or disposable equipment can help to manage the leachables risk associated with the use of these components. This presentation will focus on the proper selection of single-use equipment to ensure that it is safe and compatible with the drug formulation.
Michael Ruberto, Ph.D., President, Material Needs Consulting
9:00
Case
Study
Take II - More Findings and Updates on Our Experiences with Disposable Bags for Cell Culture Media StorageStudy
Following on Dr Masaru Shiratori's presentation at this event last year which investigated challenges with reductions in cell growth and product yields that correlated with specific disposables and the conditions of use, in this presentation we will continue to dig deeper and will present more updated information plus indepth review of the root-cause of the problem. Lessons learned and recommendations for selecting disposables for future applications will be shared.
Joseph N. Wood, MSE, Engineer I, Genentech, Inc.
9:30
Sponsored by
Applying Risk-Based Assessment of Extractables and Leachables from Single-Use SystemsThis presentation will take a closer look at various risk-based approaches, including some that may even make the identification of extractables and leachables unnecessary. Issues discussed include:
- Regulatory guidelines that can be used to conduct a risk-based assessment of extractables and leachables evaluation
- Case studies that highlight the pragmatic use of risk-based assessments of extractables and leachables in single-use systems
10:00
Networking Refreshment Break and Opening of Poster & Exhibit Hall
Biggest Issue of E&L is Standardization, or The Lack Thereof...
10:45
PDA Task Force for Single Use Systems, Presents Technical Report Overview and Concepts Focused on Extractables and Leachables
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. This technical report presents a flexible approach for achieving these goals outlining science and risk-based considerations from the following areas of focus: Technologies and System Integration, Business Drivers, Qualification and Implementation. This presentation will give the audience an introduction to the Technical Report concepts focused on E &L which must be considered when implementing single use technologies.
Robert Repetto, M.S, MBA, Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Sciences; Chair, PDA Single-Use System Task Force
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. This technical report presents a flexible approach for achieving these goals outlining science and risk-based considerations from the following areas of focus: Technologies and System Integration, Business Drivers, Qualification and Implementation. This presentation will give the audience an introduction to the Technical Report concepts focused on E &L which must be considered when implementing single use technologies.
Robert Repetto, M.S, MBA, Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Sciences; Chair, PDA Single-Use System Task Force
11:05
Update on Standards and Best Practices - Where Are We Now?
Development of standards has been considered an impediment to broader acceptance of single-use by the Biopharmaceuticals industry. There is, however, still a lack of understanding of which organizations issue standards and what is needed to develop them. This talk will provide a review of the issues and an update on what organizations are doing to develop standards and best practice guides.
Jerold Martin, M.Sc., Director & Chairman, BPSA; and Sr. VP, Global Scientific Affairs, Pall Life Sciences
Development of standards has been considered an impediment to broader acceptance of single-use by the Biopharmaceuticals industry. There is, however, still a lack of understanding of which organizations issue standards and what is needed to develop them. This talk will provide a review of the issues and an update on what organizations are doing to develop standards and best practice guides.
Jerold Martin, M.Sc., Director & Chairman, BPSA; and Sr. VP, Global Scientific Affairs, Pall Life Sciences
Point-CounterPoint Debate
11:25
Sponsored by
What is the Progress towards Harmonization of Standards and Best Practices for E&L? How Should/Does the Industry Qualify, Test, Validate, Engineer and Set Standards for Single-Use Applications?Moderators:
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Scences; Chair, PDA Single-Use System Task Force
Jerold Martin, M.Sc., Director & Chairman, BPSA; and Sr. VP, Global Scientific Affairs, Pall Life Sciences
Panelists:
Jeffrey Lee Craig, Global Director, Business Development & Marketing, ATMI LifeSciences
Morten Munk, Director, Downstream Development, CMC Biologics, Inc.
Lauren Melton, Strategic Regulatory Director, GE Healthcare
12:15
Networking Luncheon in Poster & Exhibit Hall
Challenges in Large Scale Downstream Process Using Single-Use Technologies
1:40
Chairperson's Opening Remarks
Adam Goldstein, M.S., Principal Scientist, Oceanside Operations, Genentech, Inc.
Adam Goldstein, M.S., Principal Scientist, Oceanside Operations, Genentech, Inc.
1:45
Sponsored by
Case
Study
Implementation of Single-Use TFF Technology for cGMPManufacture of DNA Vaccines and Gene TherapeuticsStudy
The advantages of single-use technologies are widely acknowledged by most biomanufacturers. However, the implementation of a new process can be time-intensive, particularly for a cGMP facility with a well-established process. Tangential flow filtration (TFF) is a critical step in the downstream processing of plasmid DNA, while the solution becomes highly viscous during concentration. This presentation addresses the challenges associated with the evaluation of Sius-LS Single Use TFF cassettes and the technology transfer from process development to cGMP. Implementation of Sius-TFF, in lieu of traditional re-usable TFF, demonstrated improved process efficiency and significant cost reduction (greater than 60%).
Ying Cai, Ph.D., Process Development Manager, VGXI, Inc.
2:15
Sponsored by
Has Disposable Chromatography Finally Arrived? A Technical Review of the Key Process Criteria of Chromatographic Performance, Flexibility and EconomicsSingle-use/disposable technologies have become standard in many of the world's biopharmaceutical companies, however, until now there has not been a broadly applicable solution for column chromatography. Data will be presented from case studies demonstrating Pre-Packed Disposable OPUS™ Columns can perform interchangeably with traditional glass and steel columns in defined purification processes.
Stephen Tingley, Vice President, BioProcess Business Development, Repligen Corporation
Panel Discussion
2:45
Sponsored by
Challenges and Limitations of Downstream Processing - Where Do We Go From Here?- Where do we go from here?
- What's the future of downstream processing?
- What's coming down the vendors' pipelines?
- How can the industry work to find alternatives to ProteinA and overcome scale limitations?
- Does pre-packed columns really make sense?
Adam Goldstein, M.S., Principal Scientist, Oceanside Operations, Genentech, Inc.
Panelists:
Mani Krishnan, Director, Single Use Processing Systems, EMD Millipore
Michael LaBreck, Global Product Manager, TangenX TFF Products, Novasep, Inc.
Joseph Makowiecki, Manager, Purification Process Development, Xcellerex, Inc.
Stephen Tingley, Vice President, BioProcess Business Development, Repligen Corporation
Ian Sellick, Director of Marketing, Pall Life Sciences
3:45
Networking Refreshment Break in Poster & Exhibit Hall
Keynote Presentations
4:30
Extracting the Full Potential of Single-UseThe current state of single use technology for end to end bioprocessing will be defined. This presentation will use case studies of the implementation challenges for biologics and vaccines. Development efforts to define the next generation processes will also be discussed including continuous processing.
David J. Pollard, Ph.D., Associate Director, Bioprocess Development, Merck & Co., Inc.
5:00
Sustainability of Single Use Technology and InnovationSingle use manufacturing technologies have the potential to revolutionize biopharmaceutical manufacturing. Since their introduction in the 1990 SUS innovations have presented both value and challenges within the industry. This presentation will outline concepts that can enable implementation as innovation of Single Use technology continues.
Robert Repetto, M.S, MBA, Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Sciences; Chair, PDA Single-Use System Task Force
5:30
Networking Cocktail Reception in Exhibit and Poster Hall
Monday | Tuesday | Wednesday
For full presentation abstracts, download the conference brochure
7:30
Networking Coffee
Case Studies of Using Single-Use Components in Vaccine Production
Shared Session with Vaccine Production Summit
Session Sponsor:
8:20
Chairperson's Opening Remarks
Ian Sellick, Director of Marketing, Pall Life Sciences
Ian Sellick, Director of Marketing, Pall Life Sciences
Keynote Presentation
8:30
Single Use Process Components: Challenges and Opportunities for Manufacturing at Industrial ScaleFacilities for manufacturing of biopharmaceuticals or vaccines offer distinct advantages up to a certain scale if their design is based on single-use process components (with particular respect to the time needed for implementation as well as for handling and operating such systems in case of frequent product changeovers). The technological limitations of such systems with respect to process volumes, transfer or mixing of bulk volumes in the range of m³, handling aspects as well as storage and shipment of frozen product will be addressed.
Peter Kraemer, Ph.D., Head Engineering Process Development and Large Scale Fermentation, Sanofi SA, Germany
9:15
Pandemic Preparedness and the Manufacturing of an Emergency Vaccine - What Role Can Single-Use Systems Play?
The manufacturing process for FluBlok/PanBlok, a recombinant protein based influenza vaccine including the combination of single- and multi-use equipment in the current process will be described. Possible scenarios for establishing surge capacity range from warm base manufacturing facilities (ready to go when they need to), to facilities used for the production of other products that can be rapidly deployed when needed through a hybrid approach, to fully disposable factories. The speaker will evaluate advantages, and disadvantages of each scenario from a financial, regulatory, and engineering perspective.
Manon Cox, Ph.D., Chief Executive Officer, Protein Sciences Corporation
The manufacturing process for FluBlok/PanBlok, a recombinant protein based influenza vaccine including the combination of single- and multi-use equipment in the current process will be described. Possible scenarios for establishing surge capacity range from warm base manufacturing facilities (ready to go when they need to), to facilities used for the production of other products that can be rapidly deployed when needed through a hybrid approach, to fully disposable factories. The speaker will evaluate advantages, and disadvantages of each scenario from a financial, regulatory, and engineering perspective.
Manon Cox, Ph.D., Chief Executive Officer, Protein Sciences Corporation
9:45
Networking Refreshment Break in Poster & Exhibit Hall
10:30
Case
Study
Tech Transfer and Process Validation of a Pandemic Flu Cell Culture VaccineStudy
Abstract not available at time of print.
Raghu Shivappa, Ph.D., Principal Scientist, Cell Culture, Manufacturing Sciences and Technology, Novartis Vaccines and Diagnostics
11:00
Case
Study
Answering the Needs of the Animal Health Industry with Flexible Manufacturing SolutionsStudy
Veterinary medicine product development and manufacturing must have flexibility that is unique for a biologics manufacturing environment. Products must be delivered with a rapid return on investment, they must be delivered in a manner that allows for robust manufacturing, and COGS must be competitive. To meet these goals, product development is expedited by using disposable micro and mini bioreactors, robustness is being achieved by sound experimental design and COGS are competitive through the judicious use of larger scale disposable solutions. Several examples will be discussed.
Huw P. A. Hughes, Ph.D., Director, Laboratory Sciences Biological Development, Pfizer Animal Health
11:30
Several critical cell lines used for the production of viral products are anchorage dependent (CEF, VERO, MRC-5, WI-38 and A549). Scale-up of adherent cell culture to commercial scale is still an issue. Alternatively, usage of micro-carriers (e.g. Cytodex) is in principle scalable, however, bead-to-bead transfer is challenging. Other options for large scale adherent cell culture include hollow-fiber perfusion systems which in general are complicate to operate. Here we describe the evaluation of a fully scalable, disposable, fixed-bed bioreactor system (iCELLis™, ATMI) for virus/vaccine production. Data for production of a Paramyxovirus (VERO) and an Adenovirus (A549) are presented.
Kai S. Lipinski, Ph.D., Head of Cell Culture & Virus Production, Vibalogics GmbH, Germany
12:00
Networking Luncheon in Poster & Exhibit Hall
Single-Use Implementation & Scaling Up Challenges
1:20
Chairperson's Opening Remarks
Wolfgang Noe, Ph.D., VP, Technical Operations, Agensys/Astellas
Wolfgang Noe, Ph.D., VP, Technical Operations, Agensys/Astellas
1:30
Case
Study
Implementing Single-use Systems: Getting Past the Obvious QuestionsStudy
Extensive use of single-use technologies has enabled the design and implementation of a functionally closed commercial manufacturing process in Bayer Healthcare's recently retrofitted facility in Berkeley, CA. The scope and complexity of being part of a large capital project has presented many unique challenges during this project. This presentation focuses on issues related to the implementation of single-use systems that are not commonly addressed in industry publications or conferences. Technical topics, as well as business process and management topics are addressed. Technology innovation opportunities for suppliers to allow single-use applications in more challenging process conditions are identified.
Yongchun Zhang, Ph.D., Principal Technology Specialist, Process Technology, Bayer Healthcare
2:00
Sponsored by
Cultivation Process Intensification Utilizing Single-Use Equipment for Perfusion Cell CulturesThis study shows how single-use bioreactor and hollow fibre cartridges, can be utilized to achieve high cell density perfusion cultures with cell densities of more than 100*10^6 cells/ml. These high cell density perfusion cultures can be used for inoculation of larger bioreactors, achieving a split ratio of up to 1:100. Perfusion productivity is compared to production in fed-batch mode.
Eric Faldt, MSc., Senior Research Engineer, R&D, GE Healthcare
2:30
Economics of Disposable Systems Implications of Scaling up for Commercial Manufacture - Scale Up vs. Scale Out
The talk will review optimal strategies for using disposables cell culture systems in hybrid facilities (a mixture of stainless and disposable technologies). In particular we will examine the costs of these facilities, their scalability and where they have advantages over a conventional reference stainless steel facility and where they do not. Specifically the questions that are addressed are:
The talk will review optimal strategies for using disposables cell culture systems in hybrid facilities (a mixture of stainless and disposable technologies). In particular we will examine the costs of these facilities, their scalability and where they have advantages over a conventional reference stainless steel facility and where they do not. Specifically the questions that are addressed are:
- What is the best configuration for the hybrid facility? Multiple 1000L bioreactors or multiple 2000L bioreactors?
- What harvest configuration should be used in terms of pooling bioreactor harvests?
- How does the best hybrid option compare to stainless steel with changing facility utilisation?
3:00
Sponsored by
Case
Study
Scale-Up Into and Implementation of a 2000 Liter Single-Use Bioreactor in an Existing cGMP Facility - Lessons LearnedStudy
CMC Biologics will present a case study and data related to implementation of a 2000 liter single-use bioreactor and ongoing cGMP operations. Key lessons learned will be highlighted and discussed, including controller decision timing, roles and responsibilities clarification between the end-user and vendors, cost/benefit analysis, timeline considerations, and infrastructure issues.
Andy Walker, Senior Director, Manufacturing, CMC Biologics, Inc.
3:30
Networking Refreshment Break and Last Chance for Poster & Exhibit Viewing
Breakout Discussion Roundtables
4:00
This session provides audiences an opportunity to sit down with speakers and fellow attendees to chat about specific issues relating to single-use applications in biomanufacturing. Attendees can elect to sit at any roundtable of their choice, and bring forward problems or challenges to be discussed at the roundtables, as well as share their experiences on trouble-shooting these challenges.
Each roundtable will be moderated by a speaker or advisor. Attendees can sign up for your roundtable in advance by emailing to mlangley@ibcusa.com to secure your seat at the preferred table. Sign-up sheets will also be provided onsite. Moderators of each table will prepare a set of questions/discussion points to be addressed during this breakout session. If you have any specific questions or issues you'd like to add to the discussion, please email to mlangley@ibcusa.com, mentioning the roundtable you are planning to join, and the questions you like to add.
Below are the current list of roundtable discussion topics:
Each roundtable will be moderated by a speaker or advisor. Attendees can sign up for your roundtable in advance by emailing to mlangley@ibcusa.com to secure your seat at the preferred table. Sign-up sheets will also be provided onsite. Moderators of each table will prepare a set of questions/discussion points to be addressed during this breakout session. If you have any specific questions or issues you'd like to add to the discussion, please email to mlangley@ibcusa.com, mentioning the roundtable you are planning to join, and the questions you like to add.
Below are the current list of roundtable discussion topics:
- Extractables & Leachables - The Bug Stops Here
Moderator: Michael Ruberto, Ph.D., Material Needs Consulting - Standardization vs. Proprietary
Moderator: Jerold Martin, M.S., Pall and BPSA - Scaling Up from Development to Commercial
Moderator: Parrish Galliher, M.S., Founder & CEO, Xcellerex, Inc. - Dos and Don'ts of Hybrid Facilities - Why, When and How
Moderator: Wolfgang Noe, Ph.D., Agensys/Astellas - Preventing Product Loss
Moderator: Russell Wong, Ph.D., Bayer Healthcare - Downstream Processing Challenges - What Do We Need to Overcome the Limitations?
Moderator: Adam Goldstein, M.S., Genentech - How to Circumvent Single-Sourcing and Maintain Supply Chain Security?
Moderator: Miriam Monge, Biopharm Services Ltd - Innovation of Single-Use Technologies: Impact on Sustainability and Lifecycle Management
Moderator: Robert Repetto, M.S., MBA, Pfizer - Trends in Single-Use Systems - Scale Limitations, Mixing, Sensors, Cleanroom Concepts, Closed Systems, Tube Welders vs Connector Systems etc.
Moderator: Kevin Lear, Ph.D., Principal Engineer and Manager, NE Operations, Hyde Engineering + Consulting, Inc. - Single-Use Applications in Fill/Finish - Considerations and Challenges
Moderator: Tesfu Mezghebe, BioProcess Associate IV, Drug Product Sciences, Human Genome Sciences, Inc.
5:00
Roundtable Wrap Up
Moderators will present a brief summary of the discussions at each roundtable.
Moderators will present a brief summary of the discussions at each roundtable.
5:30
Close of Day Two
Monday | Tuesday | Wednesday
For full presentation abstracts, download the conference brochure
8:00
Networking Coffee
8:20
Chairperson's Opening Remarks
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting, Inc.
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting, Inc.
Single-Use Supply Chain Security
8:30
Case
Study
Scalable Single-Use Bioreactors for Implementation in Sanofi Pasteur's Commercial Vaccine Manufacturing, A Supply Chain Risk AssessmentStudy
Sanofi Pasteur was considering retrofitting existing stainless steel bioreactors with disposable bioreactors for use in commercial vaccine manufacturing, the case study describes:
- How the assessment was carried out
- Key points to consider to ensure a robust supply chain
- Lessons learned
Miriam Monge, Vice President, Biopharm Services Limited, UK
9:00
Building A Secure Supply Chain Management for Single-use Components
Single use components are an integral part of pharmaceutical manufacturing processes with the potential for impacting product quality, patient safety and plant operation. To address the inherent risks associated with reliance on single use components necessitates establishing and maintaining a secure supply chain management between supplier and the end-user. This relationship often extends to the supplier's suppliers. A strict supplier management and quality plan can mitigate risks associated with on time delivery, product consistency and product adulteration. We will review approaches for controlling raw materials, necessary due diligence of suppliers, assessing the component's validation and component change control.
Kevin Lear, Ph.D., Principal Engineer and Manager, NE Operations, Hyde Engineering + Consulting, Inc.
Single use components are an integral part of pharmaceutical manufacturing processes with the potential for impacting product quality, patient safety and plant operation. To address the inherent risks associated with reliance on single use components necessitates establishing and maintaining a secure supply chain management between supplier and the end-user. This relationship often extends to the supplier's suppliers. A strict supplier management and quality plan can mitigate risks associated with on time delivery, product consistency and product adulteration. We will review approaches for controlling raw materials, necessary due diligence of suppliers, assessing the component's validation and component change control.
Kevin Lear, Ph.D., Principal Engineer and Manager, NE Operations, Hyde Engineering + Consulting, Inc.
Disposable Sensors Comparison
9:30
Evaluation of Disposable pH Sensors for Use in Single-Use Bioreactors
Single use sensors are a pivotal part of a disposable bioprocessing system. Given the complex nature of conventional pH electrodes, finding an equally robust single use sensor presents a unique challenge. This study was designed to compare new and existing single use pH sensors to an electrochemical industry standard. During the study, the sensors were exposed to a range of operating conditions to test their capabilities and shortfalls. Evaluation includes ease of use, physical response time, temperature constraints, pH range constraints, and performance degradation over time.
Meredith A. Buckner, B.S., Associate Scientist, Biopharmaceutical Development, Biogen Idec
Single use sensors are a pivotal part of a disposable bioprocessing system. Given the complex nature of conventional pH electrodes, finding an equally robust single use sensor presents a unique challenge. This study was designed to compare new and existing single use pH sensors to an electrochemical industry standard. During the study, the sensors were exposed to a range of operating conditions to test their capabilities and shortfalls. Evaluation includes ease of use, physical response time, temperature constraints, pH range constraints, and performance degradation over time.
Meredith A. Buckner, B.S., Associate Scientist, Biopharmaceutical Development, Biogen Idec
10:00
Networking Refreshment Break
Single-Use Applications in Bulk Storage & Shipping
10:30
Case
Study
A Novel Large Scale Option to Replace Stainless Steel Freeze Tanks - A Review of the Capabilities and Financial ReturnsStudy
Abstract not available at time of print.
Adam Goldstein, M.S., Principal Scientist, Oceanside Operations, Genentech, Inc.
Single-Use Technologies in Fill/Finish Processing
11:00
Considerations in Implementing Single Use Filling Systems
From media prep to product formulation, Single-use technology has made its way into the pharmaceutical manufacturing arena. The acceptance of SU options in these upstream proceses has producers of liquid formulations wanting to carry the SU concept through the final step: Fill and Finish. Dosing system options, product path design, supply chain management, process control & validation are all items that need to be considered when bringing SU technology into the Fill/Finish area. This presentation will create awareness and understanding of the many factors involved in implementing single-use product path technology into final filling operations.
Jessica Frantz, Product Manager, Single-Use Dosing Systems, Bosch Packaging Technology
From media prep to product formulation, Single-use technology has made its way into the pharmaceutical manufacturing arena. The acceptance of SU options in these upstream proceses has producers of liquid formulations wanting to carry the SU concept through the final step: Fill and Finish. Dosing system options, product path design, supply chain management, process control & validation are all items that need to be considered when bringing SU technology into the Fill/Finish area. This presentation will create awareness and understanding of the many factors involved in implementing single-use product path technology into final filling operations.
Jessica Frantz, Product Manager, Single-Use Dosing Systems, Bosch Packaging Technology
11:30
Case
Study
Advantages and Challenges in Using Disposable Technology for Fill Finish ProcessesStudy
Implementation of disposable technologies has largely centered on fermentation/cell culture and purification processes for BDS, but these technologies are also becoming more common in the fill finish or final drug product manufacturing processes. While the benefits of using disposables for fill finish processes are numerous, challenges are also sometimes encountered during implementation. This presentation will give an overview of lessons learned during the introduction of disposables into final drug product manufacturing processes.
Tesfu Mezghebe, BioProcess Associate IV, Drug Product Sciences, Human Genome Sciences, Inc.
12:00
Close of Conference
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