Conference Day 1
8:30 am - 9:00 am Registration and Coffee
9:00 am - 9:05 am PharmaIQ Welcome
9:05 am - 9:15 am Chairman's Opening Address
9:15 am - 10:00 am Implementing The Disposable Facility Of The Future
Robin Boodhoo - Manager of Continuous Improvement Sanofi-Learn how single use systems can be implemented with sustainability and life cycle management in mind
-Discuss the challenges associated with following a greener approach
-Evaluate how disposables products can really become disposable and gain a greener approach
10:00 am - 10:40 am Case Study: From Traditional Manufacturing to 100% Single Use Technology In 10 Years
Erik van Veldhoven - Head Vaccine Launch Facility Janssen
10:40 am - 11:10 am Single-Use Bag Permeability Testing in Cryopreservation Conditions
Mike Johnson - Chair, ASME-BPE Polymer Materials Subcommittee, Life Sciences Business Development Engineering Manager, Entegris. Inc. EntergrisPuncture strength, haze, Tg, extracts, and permeation rates are all single-use bag attributes about which end-users want data. While these are important characteristics, they are polymeric material properties that may or may not indicate actual bag performance. Ultimately, an end-user wants to know that the single-use bag will not put their process fluid at risk. This presentation will share pH stability data from frozen sodium phosphate solution stored in single-use bags with different gas permeation rates that are subjected to CO2 gas from sublimating dry ice.
Mike Johnson
Chair, ASME-BPE Polymer Materials Subcommittee, Life Sciences Business Development Engineering Manager, Entegris. Inc.Entergris
11:10 am - 11:40 am Coffee Break
11:40 am - 12:20 pm Continuous or Isolated – Not Feasible Without Single Use
Klaus Kaiser - Head of Downstream Bayer- Identify the opportunity to improve control of product quality for downstream purification, to be used for monoclonal antibodies
-Hear about the 100% disposable for in process fluids that enable closed system processing
-Learn about clinical manufacturing in multi purpose facilities where antibodies and antibody drug conjugates can be produced in the same cleanroom
-Determine how cross-contamination is prevented by single use technologies in closed systems for conjugation and purification
12:20 pm - 12:40 pm The Customised Standard Protocol - An Approach to Extractable Evaluation For Single Use Systems
Peter Schweyen - Project Manager SGS- Determine how to introduce the standardised extractables protocol according to USP <665> and BPOG
-Highlight the advantages and limitations of standardised protocols
-Demonstrate the limits of standardised protocols
-Underline the requirement of cutomised standard extractables protocols
12:40 pm - 1:40 pm Networking Lunch
1:40 pm - 2:50 pm Round Table Discussions
Lars Hovmand-Lyster - Senior Engineering Specialist Novo NordiskJohn Boehm - Bioprocessing Business Unit Director CPC
Mark Woodyer - Technical Lead, Manufacturing Sciences & Technology Oxford Biomedica
Simone Biel - Field Marketing Single-Use Technology Merck
- Closed System Processing With Disposable Technologies
- Sustainable approaches to single use systems
- Implementing disposable systems in downstream processes
- Implementing disposables products in upstream processes
- Technology transfer across processes with SUS
- Standardization? How to balance SUS lead times with design flexibility and supply predictability
2:50 pm - 3:20 pm Technology Showcase Day
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!
3:20 pm - 3:50 pm Afternoon Coffee Break
3:55 pm - 4:35 pm 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 appropiate room classifications
-Understand the different definitions to closed system processing
-Validate and qualify system closures for manufacturing processes
4:35 pm - 5:15 pm Keynote Address: Risk Taking and Decision Making
Caspar Berry - Professional Poker Player Risk Taking and Decision Making- Hear how to take calculated risks to create innovation in your organisation
-Take a fresh look on how to make decisions to gain a competitive edge
-Look how to approach risk and re evaluate your decision making process
5:15 pm - 5:20 pm Chairman's Closing Remarks
5:20 pm - 7:20 pm Networking Drink's Reception
After a full day of case studies and round tables, join our world famous drinks reception with your peers and meet our sponsors!