An API CrystallizationClinicfor Todays Drug Development Needs

来源 :亚太药物研发领袖峰会(Asia Pharma R&D Leaders Summit 2018) | 被引量 : 0次 | 上传用户:hfutnyd
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  Porton is providing CDMO service into Drug development for over 10 years through process research & development, manufacturing and core enabling technologies.Crystallization of active pharmaceutical ingredients (API) plays a critical role in successful drug development.Challenges associated with API crystallization can become a road block to robust production of either API or drug product, and present issues in regulatory filings.Addressing API crystallization challenges at the appropriate stage of drug development is essential.This talk will present how the Center for Pharma Crystallization (CPC) at J-Star Research, Portons process R&D force, can address successfully API crystallization challenges encountered by small and big drug developers.Capabilities of the CPC and real-world case studies of problem solving will be discussed, including crystallization process development, polymorph discovery and characterization, and API co-processing for drug product.
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