Process Analytical Technologies (PAT) enable the production of higher quality and more consistent biologic drugs and regenerative therapies. This, all at reduced cost of goods (CoGS), higher process flexibility. and faster time to market. This reality is motivating Bio-processors to move toward Automation, where new modalities and more challenging market dynamics are the new norm.
Classic bioprocessing methods are no longer satisfactory; where manual sampling and offline analysis is characterized by; slow, inaccurate, and disjointed data. Further, Operator intensive, manual control methods are severely data limited. Advanced automation is the clear solution, whereby reactive analytics and advanced statistical software can be applied to gain the PAT/QbD (Quality by Design) advantage to clearly define, monitor and control your process.
The good news is that there are now modern, scalable, in-situ, and systems integrated, advanced sensors/ software, which can provide robust and real time feedback and control, in a closed monitoring system. With these new tools, we can achieve a much safer, more efficient, and risk averse process when we utilize this real time data in an auto feedback loop, to control our CPP’s within a tighter design space, and do this with as little human intervention as possible while building a foundation for real time advanced statistical process visualization.
This workshop will highlight the possibilities of PAT/QBD with practical applications and implementation of auto feedback loops for a range of bioprocessing applications; cell therapy, protein therapeutics, and tissue engineering.