Stage 1B Process Scale-Up Considerations

  • Ajay Babu Pazhayattil
  • Naheed Sayeed-Desta
  • Emilija Fredro-Kumbaradzi
  • Jordan Collins
Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)


Processes ready for commercialization post Stage 1A need to demonstrate capability for commercial scaling. Commercial scale-up studies are conducted as part of Stage 1B process design activities. The manufacturing process is evaluated to estimate effect of scale. Product control strategy is optimized post Stage 1B studies. The successful completion of the stage ensures readiness for process performance qualification.


Scale-up Process design Critical process parameter Stage 1A Manufacturing process 


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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Ajay Babu Pazhayattil
    • 1
  • Naheed Sayeed-Desta
    • 2
  • Emilija Fredro-Kumbaradzi
    • 2
  • Jordan Collins
    • 3
  1. 1.Eurofins Alphora Reserach Inc. (Canada)TorontoCanada
  2. 2.Apotex (Canada)TorontoCanada
  3. 3.IQVIA (Canada)TorontoCanada

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