Drug substance process development

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  • Develop API manufacturing process and the quality design from “zero-level”, considering customer’s development stage, based on the know-how that leading Japanese pharmaceutical company has fostered.
    • World-top-level technologies and rich experiences on asymmetric synthesis; particularly, asymmetric metal-catalyzed reaction.
    • Synthetic technologies and the experiences to apply various/diversified reactions for API process R&D to the large-scale manufacturing.
    • Scale-up simulation technologies with various R&D experiences for the unit operation (e.g. reaction, concentration, crystallization, filtration, desiccation and grinding).
    • High-level process control technologies including highly-sensitive analytical methods and structure determination of API related substances.
    • Process optimizations based on the statistical design of experiment (DoE).
    • Flow chemistry technologies with various equipment from small-scale to kg-scale for dealing with various reactions.
    • We perform drug substance coformer (second component) screening to select the solid form to become a development candidate, through formation of an appropriate salt, co-crystal or crystal form, to improve the drug substance properties (solubility, hygroscopicity, stability, formulation properties, etc.).
  • Correspond flexibly to the needs of API manufacturing.
    • Establish and provide a supply chain of API manufacturing which is appropriate to each goal using networks with reliable partner CMO flexibly.
    • Conduct manufacturing–non-GMP or GMP–aiming to scale-up confirmation study using in-house facilities.
  • Support precisely regulatory filing for clinical studies and commercial application.
    • Conduct API process R&D, and propose the development plan with a balance between speed, economy and quality, by considering regulatory requirements on each development stage from the early-stage, based on our rich experiences on IND/NDA/MAA application.
    • Provide our capability to construct an API process control strategy (e.g. impurity controls including potential mutagenic impurities and designation of regulatory starting material).
    • Propose an optimal regulatory filing strategy based on the rich experiences.
    • Support regulatory filing, obtaining data required for the application, preparing the documents and corresponding to the inquiries from health authorities.

Technologies and Achievements

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

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