Revalidation Challenges

[VivaPalestina]

Could someone help me please, I'm trying to find the revalidation challenge that will be faced when trying to double the amount of product.

Fermentation -> Primary Recovery -> Adsorption -> Chromatography

I'm assuming that the chromatography column is already maximised at 100% capacity but only used for 40% of the time, if I want to double my output I'd simply run the column twice as many times, however other than using up media more quickly, I cannot seem to see other validation challenges that may arise and would need to be addressed.

How would the change affect the validation status of the adsorption and chromatography chain? And why would I need to revalidate the equipment interfacing the primary recovery and adsorption stage and subsequent process? Surely all I'm dealing with is more quantity?

Thank you

[chromatographer1]

Are you 'revalidating' the entire manufacturing process?

Changing the fermentation tanks, etc. all the way to the final analytical test?

Please clarify the information you seek.

Rod

[VivaPalestina]

Are you 'revalidating' the entire manufacturing process?

Changing the fermentation tanks, etc. all the way to the final analytical test?

Please clarify the information you seek.

Rod

Thank you Rod,

We're installing a larger fermenter and primary clarification chain, but assuming that there will be no change in process from the viewpoint of validation and merely addressing the stages between the feed to chromatography and the feed to the next (diafiltration) step to see what would need to be revalidated.

[chromatographer1]

Changing any aspect of any reaction vessel (fermenter) will introduce possible variations in the process. You should document that whatever changes you make do not cause any changes to the intermediate or final products of your process.

Duplicating the process exactly would not introduce this type of variation.

I would seek advice from governmental agency oversight to the requirements of revalidation they would require.

best wishes,

Rod

[VivaPalestina]

Thank you very much!