19 - 21 February, 2019 | Novotel Hotel, AMSTERDAM, Netherlands

Conference Day 2

8:30 am - 9:00 am Morning Coffee

9:00 am - 9:05 am Chairman's Opening Remarks

9:05 am - 9:40 am Verify Your Vendor! Supplier Management and Mixed Facility Harmonization

Olivia Li - GTx Engineer, Pfizer
- Discuss the single use ecosystem and life cycle management process; what are the critical success
factors to effective supplier management within this?
- Examine the reality of single use system implementation in a traditionally SS site – cleanability
considerations & closure risk management
- Analyse the challenges in mixed or transitioning facility management: Communication and risk strategy
formation
- Identify the opportunities for harmonization when onboarding SU components to site – procurement,
supply chain, engineering, tech ops and manufacturing
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Olivia Li

GTx Engineer
Pfizer

9:40 am - 10:15 am Optimising Your Technology Transfer Process – What Have You Forgotten?

Oonagh McGarry - Senior Process Equipment Engineer, Contract Consultant - Pfizer
- Understand how optimizing your technology transfer process can create a robust and compliant site
development strategy
- Why can’t I just replicate my existing model? Discuss the realities of cross-site implementation, and why
your approach needs to be customized to your site needs
- Identify some of the critical success factors in your transfer process – have you planned for them all?
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Oonagh McGarry

Senior Process Equipment Engineer
Contract Consultant - Pfizer

- Discuss the importance of change control processes in adhering to system quality and efficiency
requirements
- Identify all stakeholders impacted in new technology implementation and build a strategy for stakeholder
recruitment to avoid delays in manufacturing processes
- Avoid costly process interruptions by developing a flexible change management strategy to incorporate
unexpected surprises!
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Fabio Fachin

VP, Cell Therapy Manufacturing
Torque Therapeutics

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John Rook

Bioprocess Expert
Halix

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Francis Verhoeye

Director Single Use Technologies
GSK Vaccines

10:50 am - 11:20 am Networking Coffee Break

11:20 am - 11:55 am From Manufacture to Market: Oxford BioMedica’s Lentiviral Manufacturing Process Utilising Single Use Technology On A Commercial Scale

Mark Woodyer - Technical Manager - New Product Introduction, Oxford Biomedica
- Discuss Oxford BioMedica’s 100% disposable facility - what did it take to get here?
- Ma out the path to launching a new product using entire disposable technologies
- Analyse the challenges faced when building this manufacturing process, and how you can avoid similar
road blocks
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Mark Woodyer

Technical Manager - New Product Introduction
Oxford Biomedica

11:55 am - 12:30 pm Scalability for Allogenic Cell and Gene Therapy Production

- Identify the current state of industry technology
- Discuss the limitations of current industry equipment for the scalability and flexibility of allogenic production
- Examine where single use and disposable investment has helped to industrialise the Catapult model

12:30 pm - 1:05 pm Case Study: Application of Single Use Systems for Effective Viral Vector Development

Tony Hitchcock - Technical Director, Cobra Biologics
- Discuss the impact of single use systems in facilitating effective development of gene therapy vectors
- Analyse the unique challenges around gene therapy production and discuss the need for increased
process and technology flexibility
- Discuss how SUS can optimise the production of novel biologics whilst maintaining GMP compliance
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Tony Hitchcock

Technical Director
Cobra Biologics

1:05 pm - 1:40 pm Technology Innovation Showcase

3 of our solution providers will share their latest technology innovations to help you optimise your manufacturing processes. Take this opportunity to meet some the companies showcasing their solutions at this event!

1:40 pm - 2:40 pm Networking Lunch

2:40 pm - 3:15 pm Scaling Single Use – Can we Actually Manufacture at Capacity? Does the Answer Lie In Continuous Processing?

Sharyn Farnsworth - Principal Scientist-Manager Cell Culture, Upstream Process Development, FUJIFILM Diosynth Biotechnologies
- Analyse the current industry limitations to disposable solutions at scale and discuss the current realities of
continuous bioprocessing – is it really the model of the future or are we getting ahead of ourselves?
- Examine the industry requirements for scalable disposable technology and whether they provide a viable
commercial end to end manufacturing solution
- Examine the benefits of a continuous processing model in increasing productivity, facility capacity and
cost of goods maximisation
- Improve your process quality and reliability to avoid product and capacity wastage
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Sharyn Farnsworth

Principal Scientist-Manager Cell Culture, Upstream Process Development
FUJIFILM Diosynth Biotechnologies

3:15 pm - 3:50 pm Managing Your Single Use Facility Post Transition - Combining Compliance with Optimisation

Bianca van Leeuwen - Process Engineer, Janssen
- Discuss how to upscale production with disposable technologies - looking into Janssen’s results over the
past 12 months
- Learn from the Janssen vaccines implementation program - identify the the biggest challenges along the
implementation pathway and come up with strategies to minimise their impact
- Discuss how to move beyond needs based compliance and towards a proactive documentation strategy
for 100% product compliance
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Bianca van Leeuwen

Process Engineer
Janssen

3:50 pm - 4:20 pm Afternoon Coffee Break

4:20 pm - 5:00 pm Solutions Spotlight – Welcome to the Dragon’s Lair!

This interactive troubleshooting session targets key single use challenges and packs fun into the bargain too!
Delegates and solution providers will split into teams based on product areas and conceptualise, research
and create a brand new product to help with their single use implementation challenges. Once formed each
team’s idea will be presented to a team of expert judges, who will vote for the best idea!

5:00 pm - 5:20 pm Poll The Audience – Disposable Technology of the Future

Utilise the latest app-based polling technology to interact with your attendees and understand where the
industry is looking for technological development over the coming 12-18months!
- Discuss the industry impact of Single Use systems so far: Have we capitalised on their application?
- Identify industry drivers that will shape the technology to come: sustainability, capacity and systems
automation
- Analyse the industry adoption trends – what will the biomanufacturing space look like 5 years from now
and how do we plan to get there?

5:20 pm - 5:50 pm Chairman's Closing Remarks