Abstract
To ensure successful scale up of continuous processing to large-scale production, seamless incorporation of viral testing and clearance/inactivation into representative small scale models is warranted. For the first time at the viral clearance symposium, a session was held devoted to the adaptation of standard viral clearance/inactivation unit operations to continuous processing, with an emphasis on design of valid small scale models. In this session, the presentations and subsequent discussions identified challenges as well as pathways forward for these emerging technologies. In the first two talks, two different strategies on how to validate continuous low pH viral inactivation were discussed, focusing on molecule stability and xMuLV inactivation kinetics in the lower residence times of continuous manufacturing as well as mathematical based modeling of continuous viral inactivation processes. The third talk in the session presented a strategy to adapt weak anion exchange chromatography to a continuous manufacturing process by taking advantage of the elution pulses from bind and elute chromatography. The final and fourth talk provided data from novel spiking strategies in consideration of the high, but fluctuating, product titers in the context of continuous flow encountered in continuous manufacturing processes.
- Chromatography
- Continuous processing
- Small scale model
- Virus clearance
- Virus inactivation
- Virus spiking strategy
- Received June 25, 2018.
- Accepted June 28, 2018.
- Copyright © 2018, Parenteral Drug Association
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