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Day 1

8:30 AM Registration and Coffee

9:00 AM Chairman's Opening Remarks

Tony Hitchcock, Technical Director, Cobra Biologics

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Tony Hitchcock

Technical Director
Cobra Biologics

9:05 AM Control of Particulates in Single Use Systems (SUS) - BPSA Technical Guide on Particulates

Patrick Evrard, Sr. Manager MSAT- Manufacturing Technologies - Single-use systems, GSK Vaccines
- Gain clarification on what risk can be induced by particulates in SUS
- Understand better how these particulates should be managed, both by suppliers and end-users
- Understand better the regulations and guidance linked to particulates in SUS
- Hear what the next steps are for the control of Particulates in SUS

Patrick Evrard

Sr. Manager MSAT- Manufacturing Technologies - Single-use systems
GSK Vaccines
- Identify the areas for changes that are being considered in the revised version
- Hear how USP will provide future standards for new plastic materials and testing protocols
- Gain a unique insight into USP regulation and what the standards mean for your biomanufacturing process

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Michael Eakins

Ph.D. Vice-Chair, USP Packaging & Distribution Expert Committee
USP

10:15 AM Single-Use Technology and Sustainability: Quantifying the Environmental Impact

Hear how the life cycle assessment (LCA) study can compare the environmental impacts of producing monoclonal antibodies between single-use and traditional process technology. Detailed environmental life cycle assessment study indicates that single-use or hybrid technologies often result in reduced environmental impact compared to traditional process approaches
-Discuss how the disposal of single use components at end-of-life does not contribute significantly to the net life cycle
-Uncover how the regions of choice is an important consideration due to transports and grid difference between regions

10:45 AM Coffee Break

11:15 AM BPOG’s Best Practices Guideline for Mitigating Risk from Leachables in Polymeric Single-Use Components Used in Biomanufacturing

Aidan Sexton, Senior Process Validation Engineer, Janssen
- BPOG’s Leachables Best Practices Guideline – Purpose
- BPOG Leachables Risk Assessment Benefits & Challenges
- Phased approach
- 5 Key Attributes to Consider & Leachables Risk Scoring
- Recommended Approach Leachables Study Design

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Aidan Sexton

Senior Process Validation Engineer
Janssen
- Hear how the ASME-BPE standard benefits the implementation of single-use systems and how ASME works with other industry organizations
- Learn about content in the recently released 2016 ASME-BPE Standard related to polymeric components and materials including E&L and particulates
- Receive a preview of future standards related to single-use tube welding, single-use connections and single-use system integrity

Mike Johnson

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

12:25 PM Improve Your Productivity with Novel Developments in Single-Use Technology

-Discover how to cultivate large-scale adherent cells in single-use bio reactors with improved systems
-Hear about innovative new single-use containment systems that allow you to safely freeze and thaw fluids
-Decipher the confusing landscape of new single use technologies with expert insight

12:55 PM Networking Lunch

- Hear from all three organisations as they discuss the different standards and guidance protocols that address the use of disposable products and single use systems in biomanufacturing
- Gain the opportunity to directly ask questions about the difference in documentation from all three organisations
- Discover what the future is for regulation surround single use systems

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Aidan Sexton

Senior Process Validation Engineer
Janssen
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Michael Eakins

Ph.D. Vice-Chair, USP Packaging & Distribution Expert Committee
USP

2:30 PM Single Use Technologies Assessment Program (SUTAP): Update on Standards for Single Use Systems

Alain Pralong, Founder and Director, SUTAP
SUTAP is an organisation based on standardisation that facilitates and simplifies the communication between all stakeholders in the SUT community.
- Gain insight into the creation of SUTAP and it’s work to streamline standards
- Understand how SUTAP has progressed and hear a comprehensive overview on what the next steps are
- Learn what the objectives are for SUTAP in terms of Extractable and Leachable and Particulates testing as well as biocompability and integrity

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Alain Pralong

Founder and Director
SUTAP

3:05 PM Case study: How to Ensure Integrity of Single-Use Containers During Cold Chain Transport

-Learn how Parker Pradifa has developed a new sealing concept for Single-use plastic containers that ensure system integrity up to -85° C.
-Uncover how configuration has improved the opportunity to use disposable products and single use systems
-Understand how the role of disposable products will improve the manufacturing of biopharmaceutical and/or biosimilars

3:35 PM Coffee Break

4:05 PM Technology Demo Drive: The Most Innovative Service Providers from Across Different Single Use Technologies will be Showcasing Their Newest Product


Split into groups and rotate around the exhibition that showcases all the latest technological innovations from various leading companies

4:40 PM Case study: implementation of disposables and single use systems for mammalian and/or microbial production of therapeutic proteins for drug substance and drug product

Adriana Kiedzierska - Mencefield, Head of Pilot Plant, Polpharma
- Why the hybrid approach is the most effective
- How to best implement SUS into the biomanufacturing site at different stages
- Gaining clear component guidance for your site

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Adriana Kiedzierska - Mencefield

Head of Pilot Plant
Polpharma

5:15 PM Disposable and Single use Options in Early Phase Parenteral Drug Product Manufacturing

-Discuss single use benefits and challenges in multi-product contract manufacturing
-Challenges in managing standardisation within the supply chain
-Quality and regulatory considerations in process development and scale-up of parenteral drug products

5:50 PM Chairman's summary of Day One and Close