Crystallization process development, scale-up, and tech transfer from lab to manufacturing are challenging tasks and sensitive and expensive activities. The underlying physics and transport phenomena are scales dependent and mixing and heat and mass transfer could have a significant impact on the CQA (such as purity and form, PSD) of the product, the performance of equipment, and also impact on downstream (drug product) and bioavailability. The solubility, kinetics impact on dynamic MSZW, phase diagram, nucleation, and growth rate are some fundamental information that can be developed at the lab scale by analytical tools such as the Crystal16 or Crystalline. This knowledge is transferable for equipment design, process development, and scale-up to manufacturing scale. The synchronized multiscale, multidomain, and multiphysics simulations (based on first-principle analysis) can be utilized for rapid scale-up and equipment characterization, to avoid the manufacturing scale trial and error DoE approach.
This video is a re-recording of an online webinar by Technobis on 29 September 2022 (www.crystallizationsystems.com/trainings-and-events/Crystallization-Process-and-Product-Development)
In this webinar, some scale-up issues for crystallization were discussed with case studies. The role of fundamental knowledge about molecule behavior, such as solubility, MSZW, and polymorph change, was explored. Applications of in-silico tools (mathematical simulation) for rapid scale-up and process development and optimization, and challenges and benefits were demonstrated.
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