Utilizing Phase-Appropriate Automation to Reduce Costs Later in Development
Time: 3:30 pm - 5:30 pm
day: Pre-Conference Workshop Day – Workshop F
A major bottleneck that needs to be addressed for the successful commercialization of cellular therapeutics are the scale-up of manufacturing processes and analytical methods, and for autologous, the management of apheresis-related activities. To do this successfully and deliver more robust and effective therapies to patients, automated technologies need to be utilized from the early stages of development.
- Discuss the need for phase appropriate automation to reduce assay variability and increase robustness
- Consider step wise automation of assays to improve variability and reduce costs incrementally
- Optimize the process for critical analytical tests – at what points should we implement automation to achieve this?
- Learn about more recent advances in automated analytical tools, discussing potential regulatory implications