{"id":2407,"date":"2018-12-15T21:42:19","date_gmt":"2018-12-15T12:42:19","guid":{"rendered":"http:\/\/spera.rdy.jp\/?page_id=2407"},"modified":"2025-05-29T16:51:16","modified_gmt":"2025-05-29T07:51:16","slug":"scale-up-simulation","status":"publish","type":"page","link":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/technology\/drug\/scale-up-simulation\/","title":{"rendered":"Scale up simulation technology"},"content":{"rendered":"

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.<\/p>\n

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)<\/p>\n

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)<\/p>\n\n\n\n\n\n\n\n\n
Item<\/th>\nExamples of simulation technology<\/th>\n<\/tr>\n
Reaction<\/td>\n\n
    \n
  • Scale-up and down experiments using glass separable model reactors (0.3 ~ 6 L) and Reactor-Ready\u2122 (1 ~ 5 L)<\/li>\n
  • Scale-down experiments using various types of agitator impellers<\/li>\n
  • Scale-down experiments using EasyMax (Mettler)
    – Experiments with automatic control of stirring and temperature
    – Measurement of thermal properties with the calorimeter (HFCal)
    – Identification of potential thermal-control issues in a manufacturing process, leading to the proposal of suitable solutions.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Crystallization<\/td>\n\n
    \n
  • Scale-up and down experiments considering changes in supersaturation and agitation power<\/li>\n
  • Develop a method to obtain the desired crystal form and particle size<\/li>\n
  • Support LCM in terms of API development as cocrystal and optimal salt<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Filtration<\/td>\n\n
    \n
  • Evaluate filtration characteristics using self-developed software<\/li>\n
  • Propose optimal filtration methods based on the evaluation of filtration characteristics<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Drying<\/td>\n\n
    \n
  • Develop a drying method for obtaining hydrate<\/li>\n
  • Reduce amount of solvent which is hard to remove<\/li>\n
  • Prevent aggregation in drying<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Milling<\/td>\n\n
    \n
  • Propose optimal milling methods and scale-up operating conditions<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Using a scale-up simulation technology based on accumulated experiences in chemical engineering, SPERA PHARMA […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2327,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"682","footnotes":""},"class_list":["post-2407","page","type-page","status-publish","hentry","en-US"],"acf":[],"_links":{"self":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2407","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/comments?post=2407"}],"version-history":[{"count":3,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2407\/revisions"}],"predecessor-version":[{"id":11813,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2407\/revisions\/11813"}],"up":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2327"}],"wp:attachment":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/media?parent=2407"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}