18 - 20 February, 2020 | Leonardo Royal Hotel Berlin Alexanderplatz, Berlin, Germany
Day 3 - Future Technology
8:30 am - 9:00 am Morning Coffee
9:00 am - 9:10 am Chairman's Recap of Day Two
9:10 am - 10:30 am Mini-Workshop
Future Challenges and Opportunities
The bio-manufacturing industry is facing a number of new challenges; with the emergence of new product areas including ATMP’s, increased demands for compliance and reduction in costs. This in turn is creates opportunities for innovation from suppliers and manufacturing groups to provide solutions to these challenges. The aim of this workshop will be to look at the following key areas:
•Single use monitoring tools / in-process analytical systems
•Aseptically closed manufacturing systems
•Continuous processing
•Sustainability – recycling of single use systems
10:30 am - 11:00 am Networking Coffee Break
11:00 am - 11:40 am Case Study: Biomanufacturing for Tomorrow (BM4T)
· Gain insight of a combined USP/DSP line (SUB + 1. column) using disposables and automated systems, and a connected process
· Uncover the link from early research to phase I to market manufacturing
· Understand why it is essential to address BM4T in early research and development
11:40 am - 12:20 pm Keeping Up with the Future Demand for ATMPs: The Challenges and Opportunities of Using Disposables in Cell Therapy Manufacturing
· Discuss the uniqueness of cell therapy and the challenges in using full disposable process
· Understand the preparations for manufacturing up scaling and readiness for marketing demands
· What is the best point to move to full SU manufacturing process?
12:20 pm - 1:20 pm Networking Lunch
1:20 pm - 2:00 pm Case Study: Using New Technology to Industrialise SU Solutions: Learnings, Attention Points & Opportunities
· Demonstrate the scale effect on sizing a process step from development to commercial scale
· Understanding tech transfer process to generate a robust & reproducible performance
· Discuss implementation of a new SUS & share the approach to improve process reliability across scales
2:00 pm - 2:40 pm The Impact of the 2020 MDR on Biological Evaluation of Medical Devices, Including the Role of Extractables and Leachables in Biological Risk Assessment
• Identify what is meant by biological safety and overview the relevant guidance documents
• Discuss the parts of the MDR which relate to biological safety
• Will the MDR requirements have an effect on biological safety evaluation going forward?
2:40 pm - 3:10 pm Networking Coffee Break
3:10 pm - 3:50 pm Single Use Tools for the Personalise Medicine Production
• Look at the expansion in demand for plasmid DNA for gene therapy application
• Discuss how this has led to the rapid production of small high quality batches of multiple plasmid DNA constructs
• Understand how this increases personalised medicine
• Identify how single use manufacturing tools can provide manufacturing solutions to these novel challenges
3:50 pm - 4:30 pm Summative Discussion: The Future of Disposable Technologies
• Discuss the future of single use technologies and automisation
• Manage the impact of extractables and leachables in single use systems
• Identify how to scale up opportunities with disposable systems
• Understand how to better manage stakeholder relationships to utilise external suppliers