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Day 2

8:15 AM Breakfast Briefing: Creating a New Synergy Between Single-Use Adopters And Suppliers

Celia Landers, Senior Product Manager , Merck
The clock is always ticking. Patients watch for new, innovative treatment options and drug developers and manufacturers race to achieve milestones, advance promising molecules and explore new approaches to improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Adopting and implementing single-use systems is more than incorporating disposable components into the process. It requires a new dynamic between the adopter and their suppliers to nimbly and effectively address such challenges. This session will describe best practices and case studies for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike an optimized balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock.
Key Points:
1) How to find the optimal path to balance standardization in single-use with design flexibility and supply predictability.
2) Best practices in establishing a collaborative relationship between single use adopters & suppliers: partnering with single use suppliers for optimized supply security.
3) Understanding the methodology used to create an optimized SU component library to provide comprehensive assembly design and documentation support without compromising on quality.

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Celia Landers

Senior Product Manager
Merck

8:30 AM Registration and Coffee

9:00 AM Chairman's Opening Remarks

9:05 AM Case study: Engineering of Single Use Systems in a 100% Disposable Site

Mark Woodyer, Technical Lead, Manufacturing Sciences & Technology, Oxford Biomedica
- Uncover the possibilities of using disposable products in closed single use system processing and what the best approach is to automating closed single use systems
- Hear how a 100% disposable site is successfully achieved
- Understand what the best practice is in design, testing and validation of single use systems on site.

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Mark Woodyer

Technical Lead, Manufacturing Sciences & Technology
Oxford Biomedica

9:40 AM Case Study: The Benefits of Single Use Technologies in Downstream Processing

Andrew Brown, Manager, Process Engineering & Downstream Development,, Allergan

- Uncover how to overcome the different challenges when implementing single use technologies in downstream processing
- Hear how experiences in different technologies have lead to conventional and disposable technologies working side by side
- Understand what the benefits are for using single use systems in mammalian production and why they differ for microbial production
- Gain practical insight in maximizing production efficacy and learn how this approach can help you choose the right products for your site

Andrew Brown

Manager, Process Engineering & Downstream Development,
Allergan
While the utilization of single-use systems has provided significant benefits to bioprocessing there are still factors limiting their use in critical downstream applications, such as bulk drug substance storage and final fill. Through the implementation of a new, innovative single-use bag material, the presentation will demonstrate
- Solutions to bag breakage and loss of production material, and contamination from Extractables/Leachables
- Product security at low temperatures down to -85C

Mike Johnson

Chair, ASME-BPE Polymer Materials Subcommittee, Life Sciences Business Development Engineering Manager, Entegris. Inc.
Entergris

10:45 AM Coffee Break

11:15 AM Case study: Identifying the right strategy for implementing disposable products and single use systems

Xavier Derouck, Senior Sourcing Group Manager of Bioprocessing, GlaxoSmithKline Biological
- Uncover what the risks are when implementing disposable products
- Ensure the correct regulatory compliance is associated with new product implementation
- Understand how to identify the new technologies and latest trends in single use systems

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Xavier Derouck

Senior Sourcing Group Manager of Bioprocessing
GlaxoSmithKline Biological

11:50 AM Using Single-Use Systems in Fill Finish Stage of the Bioprocess

- Understand the advantages and disadvantages from using SUS in Fill – Finish
-Learn what the differences are between single use and multi use systems for Fill Finish in terms of: Risk Drivers, Cleaning, Time to market and cost
-Plan you decision on choosing the right solutions for the Fill-Finish stage with detailed analysis on the different possibilities for product implementation

12:10 PM Roundtable Discussion

Roundtable One: Can challenges surrounding intercompatibility be solved from standardisation of components?


Roundtable Two: Is a standardised validation testing protocol possible?


Roundtable Three: How will standardisation affect the developing market of disposable products?


Roundtable Four: Implementing disposable solutions for optimized downstream processing Anna Holefors, CEO and Founder, In vitro Plant-tech

Roundtable Five: Implementing disposable solutions for optimized upstream processing – John Rook, Bioprocess Specialist USP, Halix


Roundtable Six: Quality Assurance of Single Use Systems in Bio processing



12:45 PM Networking Lunch

1:45 PM Use of Single Use Systems for the Production of Both Plasmid DNA and Viral Vectors for Clinical Studies

-Uncover how SUS has helped facilitate rapid growth in the development of gene therapy vectors
-Understand how demand of increased production of different plasmid DNA and live viral vectors creates challenges for production in terms of the need for increased operational flexibility and GMP compliance
-Hear how SUS has supported early and late phase clinical studies and allowed optimized production of novel agents

2:20 PM How to Stay Ahead of New Disposable Technologies

Constance Perrot, EASE Project Director, University of Strasbourg
- Investigate how to implement disposable technologies and stay ahead of the developing market
- Hear from the University of Strasbourg on what the route to success is in disposable manufacturing. The new EASE – European Aseptic and Sterile Training Centre is set up to train you on jobs that take place in the white room.
- Gain unique strategies to help perfect single use system integration into your facility

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Constance Perrot

EASE Project Director
University of Strasbourg

2:55 PM Coffee Break

3:25 PM Realizing the Benefits of Single Use Technology in Manufacturing:

- Uncover how Single Use Technologies allow for improved manufacturing flexibility
- Maximize throughout and execution with disposable solutions
- Compare the benefits of single use adoption in mammalian cell culture manufacturing to experiences with traditional systems

4:00 PM Process and bioreactor development and optimization by means of Computational Fluid Dynamics

Sören Werner , Deputy Head Cell Cultivation Technique, ZHAW Life Sciences and Faculty Management
- Understand how the use of CFD can facilitate identifying the detailed hydrodynamic properties of different bioreactors
- Uncover what the differences are between different types of mixing principles of bioreactors and their effect on production processes
- Hear case studies on how production optimization is achieved through modern bioreactor characterization

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Sören Werner

Deputy Head Cell Cultivation Technique
ZHAW Life Sciences and Faculty Management

4:35 PM Chairman's Closing Summary