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CASE STUDY

Accelerated Cell Line Development to Shorten IND Filing Timeline

Background:

This case involves implementing an accelerated clone stability study to shorten the CLD timeline.


Result: 

Initiated an accelerated clone stability study to support earlier final top clone selection. All clones tested showed highly similar stability results compared to conventional stability study. Thus, the accelerated study allows for earlier stability prediction and final clone selection, shortening the CLD timeline by 2 months and the IND filing timeline accordingly.


CASE STUDY