Single-Use Technologies for Rapid Manufacturing
Discover new approaches to rapid scale translation
27 - 29 April 2015
The module aims to deliver new training material specific to single-use technologies
encompassing different process steps, scales of operation and cell/product systems. It will:
Consider the whole process and provide tools useful for the evaluation and adoption of single use systems for a range of process steps;
- Build knowledge of engineering fundamentals in single-use systems and provide confidence in
- scale translation and in the use of these as scale-down models;
- Focus on the different stages of the development pathway, from initial discovery and screening studies to manufacturing;
- Discuss adoption of these technologies for different cell systems and products (antibodyproducing
- mammalian cells used as base case study, adherent cells and high cell density organisms among others);
- Provide training on singleuse technologies specific characteristics and requirements(sterile connections and disconnections, standardization, sensor technology, toxicologic profiles and regulatory approval).
The course will be delivered as an intense 3 days module, as part of the already established MBI Training Programme hosted by the Advanced Centre for Biochemical Engineering (ACBE) at UCL. A number of leading vendors and industrialists in the sector have been engaged to define the course objectives, its content and methods of delivery.
Who should attend?
The course is suitable for engineers, biotechnologists and those with a life
science background who are or plan to work with single-use technologies for different processes and products. In particular the module will suit those responsible for the uptake and selection of the technology, for process development, technology transfer and scale translation. Practical sessions will help building confidence in the use of the technology for those planning to use it for the first time. Delegates will also learn from industrial experts experiences on the challenges and opportunities around single-use systems.
Fundamentals and scale-up
• Engineering fundamentals and mixing in SUB
• Tech transfer and scale translation
• Industrial speaker presentation on scale up case study
• SUB set-up, basic operation and control
Technology evaluation and selection
• Upstream processing
• Primary recovery and downstream processing
• SUT evaluation from drug screening to manufacturing: an industrial perspective
• Sensor technology and control software
Facility design and validation
• SU-based manufacturing platform: ideas around the facility of the future
• Validation and regulatory approval process for both vendors and end-users
• Impact of SUT on the reduction of carbon footprint within a facility
• Aseptic connections and disconnections, standardization issues, multiple operations set-up
Dr Martina Micheletti, UCL - Module Leader
Prof Gary Lye, UCL
Invited Expert Speakers
Guenter Jaschies, GE Healthcare
Alison Rees-Manley and Michelle Lennon, Sartorius Stedim
Naveraj Gill, GE Healthcare
Martijn Kreukniet, Applikon Biotechnologies Ltd
Marc Woodyer and Marc Ayles, Pall
David Pollard, Merck & Co Inc.
Paul Beckett, Merck Millipore
Adam Hawthorne, PM Group
A networking dinner will be held on the first evening.
The module costs £1450, with a £100 discount if you register and pay before 16 March 2015.
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