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Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen Duquesne University Center for Pharmaceutical Te

DEVELOPMENT OF QUALITY BY DESIGN (QBD) GUIDANCE ELEMENTS ON DESIGN SPACE SPECIFICATIONS ACROSS SCALES WITH STABILITY CONSIDERATIONS Scale up consideration – NIR calibration. Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen

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Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen Duquesne University Center for Pharmaceutical Te

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  1. DEVELOPMENT OF QUALITY BY DESIGN (QBD) GUIDANCE ELEMENTS ON DESIGN SPACE SPECIFICATIONS ACROSS SCALES WITH STABILITY CONSIDERATIONS Scale up consideration – NIR calibration Benoit Igne, Sameer Talwar, Brian Zacour, Carl Anderson, James Drennen Duquesne University Center for Pharmaceutical Technology

  2. Blend Scale up issues • Volume of powder sampled decreased • Differences in fill volume • Blending dynamics changed • Blender shape changed • Different NIR sensors • ThermoFisher Spectral Probe to ExpoTech ePAT 601 Blend monitor

  3. Efficient calibration approach • Used limited number of levels • 0%, 100%, nominal, granule • Classical least squares based method • Regression vector is based on the pure components • Consequently, the differences in regression vector from scale to scale, from NIR sensor to NIR sensor was mainly a function of the instrument differences

  4. Efficient calibration approach • No unique samples • No degradation of sample • No transfer set / standardization method • Reduced time and effort for calibration model development: “calibration in hours”

  5. Calibration comparison Laboratory scale Scale-up API MCC HPC Starch RMSEC (%) = 1.40 0.95 1.08 0.70 RMSECnom (%) = 1.66 1.09 1.25 0.75 API MCC HPC Starch RMSEC (%) = 1.56 0.81 0.98 0.41 RMSECnom (%) = 1.93 1.58 1.38 0.50

  6. Blend end point • At laboratory scale • Both instruments gave similar outputs • RMSNV under error of validation • At scale up • RMSNV under error of validation • Blend was stopped in a similar manner, based on similar criteria • Similar definition of homogeneity • Differences in scales of scrutiny

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