Conference Day 2

8:30 AM - 9:00 AM Morning Coffee

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

9:10 AM - 9:50 AM Life Cycle Management Of Single Use Systems

Francis Verhoeye, Director Biological Development Europe, Zoetis Belgium SA
-Determine how the relationship between suppliers can be optimised
-Analyse how to enhance life cycle management of single use systems
- Look at the relationship between suppliers and product life cycles needs to be improved

Francis Verhoeye

Director Biological Development Europe
Zoetis Belgium SA

9:50 AM - 10:30 AM Case Study: Technology Transfer with SUS in Biomanufacturing

Adriana Kiedzierska - Mencefield, Head of Pilot Plant, Polpharma
-Determine how to reduce complexities within manufacturing when conducting technology transfer
-Understand how to simplify your processes to be more efficient
-Learn the benefits of standardised approaches and where you should customise and where you should not
-Explore the expansion of production capabilities through duplicate facilities including horizontal against vertical approaches

Adriana Kiedzierska - Mencefield

Head of Pilot Plant
Polpharma

10:30 AM - 11:00 AM Networking Coffee Break

11:00 AM - 11:40 AM A Risk Based Approach To Operating Closed Systems In CNC Ballroom

Lars Hovmand-Lyster, Senior Engineering Specialist, Novo Nordisk
- A risk based approach to assess appropriate room classifications
- Understand the different definitions to closed system processing
- Validate and qualify system closures for manufacturing processes

Lars Hovmand-Lyster

Senior Engineering Specialist
Novo Nordisk

11:40 AM - 12:00 PM The Customised Standard Protocol – An Approach to Extractable Evaluation for Single Use Systems

Peter Schweyen, ,
-Introduce in the standardised extractables protocol according to USP <665> and BPOG
-Highlight the advantages and limitations of standardised protocols
-Demonstrate the limits of standardized protocols
- Underline the requirement of customised standard extractables protocols

Peter Schweyen


12:00 PM - 12:30 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!

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:10 PM Commercialisation Of Oxford BioMedica’s Platform Lentiviral Manufacturing Process Utilising Single Use Technology

Melanie Bull, Senior Production Manager, Oxford BioMedica
- Hear about Oxford BioMedica’s new 100% disposable facility
- Discuss the steps taken to launch a new product using entire disposable technologies
- Learn about which challenges where overcome when building this manufacturing process

Melanie Bull

Senior Production Manager
Oxford BioMedica

2:10 PM - 2:50 PM Case Study: Challenges In Vector Production With Disposable Products

Tony Hitchcock, Technical Director, Cobra Biologics
- Gain an overview of the unique challenges associated with vector production
- Plan your production around the GMP considerations that need to be established for compliant protocols
- Hear how different platforms in SUS can be utilised during production

Tony Hitchcock

Technical Director
Cobra Biologics

2:50 PM - 3:20 PM Afternoon Coffee Break

3:20 PM - 4:00 PM Scaling Up ATMP Production and Developing Large Scale Closed System Processes With Disposable Systems In A GMP Compliant Environment

Koen Bezemer, Head of Production for ATMP, Erasmus MC
- Determine how the move from conventional cell culture to closed system processes is developing with
disposable technologies
- Hear how to upscale production of GMP-compliant allogenic tumor cell line lysate using disposable technologies
- Understand how to transfer systems to a large scale disposable system

Koen Bezemer

Head of Production for ATMP
Erasmus MC

4:00 PM - 4:40 PM Panel Discussion: Disposable Product Documentation

Mark Woodyer, Technical Lead, Manufacturing Sciences & Technology, Oxford Biomedica
- Discuss what information is missing from product supply and risks associated
- Hear what data needs to be provided in relation to sterility and shelf life
- Understand how the requirements of information can be standardised for all areas of manufacturing

Mark Woodyer

Technical Lead, Manufacturing Sciences & Technology
Oxford Biomedica

4:40 PM - 4:50 PM Chairman's Closing Remarks