About the webinar
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.
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.
Nima Yazdanpanah - Principal at Procegence
Nima is a consultant on advanced manufacturing and modeling and simulation applications in Bio/pharmaceutical and fine chemical industries. His area of expertise covers process simulation, particulate matter, process design, and advanced manufacturing.
With more than 15 years of diverse experience in different industries, Nima has worked in R&D, process design, and MSAT sections. Before starting his consultancy firm (Procegence), Nima was a research scientist with the US Food and Drug Administration. He was appointed as a member of an expert team for the advancement of emerging technologies to modernize pharmaceutical manufacturing. Nima received his Ph.D. from The University of Sydney, Australia. And after was a postdoctoral research associate at MIT.
Nima has a diverse background in the industry (energy, food, pharma, fine chemicals), academia, and government.