Technology

Scale up simulation technology

Using a scale-up simulation technology based on accumulated experiences in chemical engineering, SPERA PHARMA can identify/solve a scale-up challenge in advance, ensuring process robustness and the productivity.

For example, a robust crystallization method for API, with a character of easy oil-downed and a large variation of the distribution of crystal particle size, has been established by our simulation technology. (Cryst. Growth Des., 2014, 14 (11), 6006)

Moreover, a robust and efficient drying process for a hydrate API with high quality in commercial scale has been developed by considering the vacuum drying conditions in detail as a process simulation study. (Separation Process Engineering, 2013, 43, 375)

Item Examples of simulation technology
Reaction
  • Scale-up and down experiments using glass separable model reactors (0.3 ~ 6 L) and Reactor-ReadyTM (1 ~ 5 L)
  • Scale-down experiments using various types of agitator impellers
  • Scale-down experiments using EasyMax with automatic control of stirring and temperature
Crystallization
  • Scale-up and down experiments considering changes in supersaturation and agitation power
  • Develop a method to obtain the desired crystal form and particle size
  • Support LCM in terms of API development as cocrystal and optimal salt
Filtration
  • Evaluate filtration characteristics using self-developed software
  • Propose optimal filtration methods based on the evaluation of filtration characteristics
Drying
  • Develop a drying method for obtaining hydrate
  • Reduce amount of solvent which is hard to remove
  • Prevent aggregation in drying
Milling
  • Propose optimal milling methods and scale-up operating conditions

Inquiries About Service

SPERA provides CMC solutions from early-stage through new drug application.

Contact US

page top