Day 1 - System Implementation
8:30 am - 8:55 am Welcome Coffee & Registration
8:55 am - 9:00 am PharmaIQ Welcome
9:00 am - 9:10 am Chairman's Opening Address
9:10 am - 9:30 am Speed Networking
A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge
9:30 am - 10:10 am Case Study: A Playbook to Fully Utilise Closed Systems in Modern BioPharma Facilities
• Build the roadmap to biopharmaceutical manufacturing and their partners in developing, assessing and verifying unit operations leading to an appropriate facility design that is “right classified”
• Hear first-hand about this industry-developed document to understand the tools, steps and documents required to adequately risk assess and qualify modern facilities that make use of modular, closed technology
• Learn how following a methodology results in significant gains in reducing the time to deliver the facilities and CAPEX and OPEX costs
10:10 am - 10:50 am Case Study: Implementation of Additional Single Use Equipment in Clinical Manufacturing with the Possibility to Run Different Processes
• Understand why clinical manufacturing of monoclonal antibodies has to be close to the technical level of the early and late stage development departments
• Deliver the pipeline with new modalities and processes
• Discuss the implementation of new single use equipment, usable for classical and intensified processes and the first results in the clinical supply centre
10:50 am - 11:20 am Networking Coffee Break
11:20 am - 11:50 am Scale single-use bioprocessing operations for the digital age
- Review how flexible and scalable solutions are critical for companies to efficiently manufacture smaller batches of tailored medicines
- Scale single-use bioprocessing operations for the digital age through smart Automation and OT solutions
- Discuss how the right control-strategy through connectivity, information, and modular equipment will help smaller-scale, more efficient operations
- Cover how Automation improves operational efficiency with reduced production risk and streamlines workflows resulting in faster times to market, for example, through improving the operators’ situational awareness as well as their ability to make better data-driven decisions
11:50 am - 12:30 pm Single-Use Bioprocess Platform for Veterinary Vaccine and Biopharmaceutical Pilot-Scale Production
· Understand the implementation journey taken to accelerate veterinary biological product development
· Identify the challenges of integrating vaccine and biopharmaceutical processes
· Learn about the single use qualification and implementation process in a multi-product facility
12:30 pm - 12:45 pm Intensifying the Process of Cell Harvesting: Multicycle Cake Filtration
- Understand the concept of multicycle filtration inside a single-use frame
- Demonstrate flexibility of scale-up by cyclic biomass discharge
- Discuss the influence of cell density and pH on process control and filter performance
12:45 pm - 1:30 pm TECHNOLOGY INNOVATION SHOWCASE
Use this opportunity to meet our suppliers, learn about their latest technology innovations and understand how these can help optimise your manufacturing processes. Discussing the challenges will only get you so far – you need to take solutions back to your sites! Use this opportunity to see solutions in action, and pose your most pressing questions to leading technology specialists…
Sponsored by: Levitronix
Sponsored by: Eldon James Corporation
Sponsored by: Equflow
1:30 pm - 2:30 pm Networking Lunch Break
2:30 pm - 3:50 pm Mini-Workshop
Safety Assessment of Extractables & Leachables
All biopharmaceutical processing materials have to be evaluated to determine whether they impact the safety and efficacy of the final drug product. However, it can be extremely difficult to get reliable data, and with the stakes so high, would you want to take this risk? Join this session to:
•Understand the importance of E&L structure identification
•Discuss the concept of the Threshold of Toxicological Concern (TTC)
•Gain insight of the limits applied to genotoxic E&L incl. the “staged” TTC concept
•Understand the limits applied to non-genotoxic E&L incl. the Cramer substance classification system
•Learn the limits applied to elemental Impurities
•Perform a toxicological risk assessment to meet the expectations of Health Authorities
3:50 pm - 4:20 pm Networking Coffee Break
4:20 pm - 5:00 pm A Practical Guide to Single-Use Implementation (a CDMO's perspective)
· Review the considerations for implementation of single use technologies
· Discuss the lessons learned during implementation
· Share insight on scale up/down modelling and mass transfer considerations
Sharyn Farnsworth
Principal Scientist - Manager Cell Culture, Upstream Process DevelopmentFujifilm Diosynth Biotechnologies
5:00 pm - 5:40 pm Designing Sterile Filtration in Aseptic Processing Using Single Use Technology
• Review the new Revision Annex 1 with respect to Single Use Systems
• Consider initial designs for Single Use Systems, including; design concepts/ location of bacterial retention filters inside or outside the Isolator or RABS/mock-ups
• Look at the handling and set-up of Single Use Systems, as well as the sterilisation process and product filter preparation steps
• Uncover the approach to qualification for Single Use Systems
