Purifaction stage process change

[zcuteeye]

Can anyone help me please?

I need to submit a project on the 28th February and am struggling with a few concepts: we are told that in a fermentation plant for protein processing, identical parallel fermenter and primary clarification chain are being added to the existing fermentation and clarification systems. However, the chromatographic column series remains the same. Basically, the new process will have two fermenters, two clarification systems with one chromatographic system. We are asked to analyse the problem and recommend revalidation strategies for the new changes. However, we are not given any information on the existing system other than there was originally one fermentation process which is now being doubled and that the protein is developed from a lab validated pilot. Can anybody help me with a few pointers? Sorry for the VERY long question

Very desperate engineering student

[Bruce Hamilton]

One of your classmates has already posted the same question a couple of days ago, unfortunately they weren't ethical enough to inform us it was a class assignment.... The same information could help you.

The thread is entitled
"Revalidation of chromatography with upstream process change."

Bruce Hamilton

[zcuteeye]

Thank you very much