Day 2 - System Management
8:30 am - 9:00 am Welcome Coffee
9:00 am - 9:10 am Chairman's Recap of Day One
9:10 am - 10:30 am Mini-Workshop
Disposable Bioreactors: Fluid Dynamics, Mixing, Shear Stress, Gas Transfer Rates – Insights for High-Density Cultures of CHO Cells
•Discuss the mechanical principals such as waving, rocking, stirring and shaking to provide homogeneity and oxygen transfers to CHO cells in disposable bioreactors
•Consider scalability and the capability of any of the systems to provide data at a small scale (mL to L) predicting the performance of the respective system at larger scale
•Uncover key insights obtained with different mixing approaches and discuss benefits and drawbacks of them for high-density cultures of CHO cells
Disposables Materials for Tox Protein Production: A Case Study for 0.5 Kg Manufacture
•Explore the steps required from cell thaw to manufacture and purification of > 500 grams of high-quality protein batch using exclusively disposable materials
•Highlight the importance of using pre-qualified materials from various providers
•Understand how integrating trained teams for use of the materials with no worries about sterility will reduce time lines significantly
10:30 am - 11:00 am Networking Coffee Break
11:00 am - 12:00 pm INTERACTIVE DISCUSSION GROUPS
Speakers:
Philipp Wolf Expert Biopharmaceutical Single Use Equipment Boehringer Ingelheim
Laura O'Connell Manufacturing Process Specialist Janssen
James Pullen Director of Downstream Processing Fujifilm Diosynth Biotechnologies
Nadav Eshkol Development Manager Pluristem Therapeutics
Amir Goudarzi Head of Process Engineering UCB
Marc-Antoine Kaag Global Product Manager Sampling Merck
Philipp Wolf Expert Biopharmaceutical Single Use Equipment Boehringer Ingelheim
Laura O'Connell Manufacturing Process Specialist Janssen
James Pullen Director of Downstream Processing Fujifilm Diosynth Biotechnologies
Nadav Eshkol Development Manager Pluristem Therapeutics
Amir Goudarzi Head of Process Engineering UCB
Marc-Antoine Kaag Global Product Manager Sampling Merck
During this part of the summit, delegates will be sorted into groups of 10-12 to take part in interactive discussions around the topics below. Delegates will get the opportunity to select and pre-register for the topics. Discussion groups are kept small to ensure all delegates get the opportunity to ask their most pressing questions, ensuring a perfectly tailored experience.
•The Shelf Life of Expensive Articles
Philipp Wolf, Expert Biopharmaceutical Single Use Equipment, Boehringer Ingelheim
•Supplier Material Qualification of Disposables – Standardization & Challenges
Laura O’Connell, Manufacturing Process Specialist, Janssen
•Lessons Learnt Working with Different DSP Single Use Systems
James Pullen, Director of Downstream Processing, Fujifilm Diosynth Biotech
•The Challenges and Opportunities of Using Disposables in Cell Therapy Manufacturing
Nadav Eshkol, Development Manager, Pluristem Therapeutics
•Using New Technology to Industrialise SU Solutions
Amir Goudarzi, Head of Process Engineering, UCB
•Next-Generation Sampling and Process Monitoring
Marc-Antoine Kaag, Global Product Manager Sampling, Merck
12:00 pm - 1:00 pm Networking Lunch Break
1:00 pm - 1:30 pm Early Removal of Impurities in Microbial Processes by Chromatographic Clarification
- Early impurity removal from industrial products expressed in E. coli
- Reduction of endotoxins from soluble and inclusion body product processes by >4 LRV
1:30 pm - 2:10 pm Managing Systems to Prepare for Supply: Cold Chain Development with Flexible Solutions for Drug Substance Fill, Freeze & Thaw
· Discuss strategies to maximise bulk drug substance container integrity
· Explore the alignment of global interfaces for development, clinical and commercial manufacturing
· Consider the manufacturing concept for a robust cold chain, ensuring flexibility and scale-up opportunities, and development considerations
2:10 pm - 2:50 pm Technology Transfer with Single Use Systems
· Look at how you can 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
2:50 pm - 3:20 pm Networking Coffee Break
3:20 pm - 4:00 pm Case Study: Global Sterile Transportation and Formulation of an Adjuvant
• Understand how to develop a solution for global use
• Uncover the challenge of sterile product transportation
• Discuss the pros and cons of single use solutions in this type of application
4:00 pm - 4:40 pm Streamlining the Qualification of Single Use Systems: BPOG’s Risk Assessment and Vendor Alignment Tools
- Learn about best practices to document supplier validation data and identify gaps in your single use component
- Apply a risk based approach to determine whether to leverage vendor data to avoid non value added repeat testing
- Hear an update on BioPhorums collaboration to develop best practices for the industry for key areas of disposables implementation
4:40 pm - 5:20 pm Panel Discussion: Where Are We Now? And Where Are We Heading?
• Discuss the pros and cons of both with real-life case studies and examples
• What effect does this have on standardisation of design?
• Take home message: Go back to your respective facilities and question why you use your methodology and what you can bring back with you
