Module 9 2024

03/09/2024

Bioassay Validation

• Example format (2 x 96 well plates/assay)

Assay Plate 1

Assay Plate 2

Run

Analyst

Cell bank

TA1

TA2

TA3

TA4

1

1

71

71

50

100

2

2

200

141

50

50

1

3 4

1 2

200 141

200 141

71

Specificity

100

100

5

1

100

50

71

71

6

2

50

50

141

200

2

7

1

Specificity

71

200

200

8

2

100

100

141

141

9

1 or 2

1 or 2

Stability Stability Stability Stability

• Different target potency levels tested and compared to Reference (=100%).

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Bioassay Validation

Results • Different concentrations of analyte are tested to show precision and accuracy at different target potency levels. • Target potency levels: 50%, 71%, 100%, 141%, 200% are often tested. Log values measured – equally spaced on the x axis.

Precision, range and linearity

Accuracy

The Organisation for Professionals in Regulatory Affairs

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