Inline spiking for viral clearance validation of continuous processes
2015
- 1Citations
- 1,170Usage
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Citation Benchmarking is provided by Scopus and SciVal and is different from the metrics context provided by PlumX Metrics.
Metrics Details
- Citations1
- Patent Family Citations1
- 1
- Usage1,170
- Downloads1,041
- 1,041
- Abstract Views129
Conference Paper Description
Conventional clearance validation employs batch spiking using a uniform feed. In continuous processing, the feed to a unit operation can vary over the course of processing. An example would be an elution peak from an upstream step where the salt and protein concentrations vary over the course of operation. Batch spiking would not represent manufacturing practice in this case. Employment of inline spiking allows a scale down version of changing feed to be used for spiking studies. This talk will describe the qualification and application of the inline spiking method with a virus filter.
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