丁香集锦:关于方法学验证和单克隆概率

2017DEMOCell MetricDEMOCell MetricDEMODEMO

Imager

1.

便

Candidate Cell Line

MCBMCBGMPGMPGMP

SOP

Imager

2.

AnalyticalCell LineImagerLLOD

>95%

a. Tank

b.

c.

d.

e.

f. Ghost CellDay0Day4/5/7

 

24hGhost cell 12

24h使

ghost cellghost cell20%

1000/20min40min1h2h3h1h99%1h1h1h

1. 2. 3. CHOCHOCHOS3h20%20%Day02VIPs

 

FDAreviewer0.5 cell/well0.595%

960.561%5939%373730%19%30%/39%=77%23%0.510.23*0.23=95%

 

0.5400.530

IND fillingReviewerIND0.5cell/well, 990.50.5

0.5

FDA Reviewers 0.5Cell MetricFDA