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Linking Drug Stability to Manufacturing Risk Assessment Approaches. L. E. Kirsch Stability team leader. Stability in Design Space. L t End of Expiry. Post-Manuf. Kinetic Model. Manuf. Design Space Model. L 0 D 0. Manufacturing stability measurements: criteria and uses

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linking drug stability to manufacturing risk assessment approaches

Linking Drug Stability to ManufacturingRisk Assessment Approaches

L. E. Kirsch

Stability team leader

stability in design space
Stability in Design Space

Lt

End

of Expiry

Post-Manuf.

Kinetic Model

Manuf. Design Space Model

L0

D0

  • Manufacturing stability measurements: criteria and uses
    • Rationality based on understanding of instability
    • Correlates to shelf-life
    • Correlates to risk: failure to reach desired shelf-life without exceeding critical instability target
slide3
Correlation between Shelf-life and Manufacturing-stability Measurements(preliminary long term stability studies)

Shelf-life estimated from

linear extrapolation of room

temperature stability data

logistical regression model for stability risk assessment

1.00

1

0.75

failure

prob

0.50

0

0.25

0.00

.175

.200

.225

.250

.275

.300

D0 + L0

Logistical Regression Model for Stability Risk Assessment
  • Shelf-life = Time to 0.4 % lactam(linear extrapolation of long-term stability data)
  • Stability failure: Shelf-life < Desired target dating (e.g. 2 years)
  • Logistical Regression model:
    • probability of stability failure as a function of the manufacturing-stability measurements (L0 and D0, mole %)
estimated stability risk application of logistical regression model
Estimated Stability Risk application of logistical regression model

Lab Pilot Lots

Lab Bench Lots

long term stability
Long-term stability
  • Objectives
    • Demonstrate relationship between Manufacturing-related stability measurement (MSM: D0 and L0) and shelf-life
    • Demonstrate/validate solid state degradation model
    • Construct definitive “Risk-based” Design Space Models
  • Current state
    • Studies underway