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API process development depending on each development stage

SPERA PHARMA develops and proposes API manufacturing process satisfying customer’s needs.

Goals for process R&D depend on the development stages and situations for development programs. In general, while the speed to support development timeline is highly required in an early development stage, the robustness and R&D cost saving are considered in a middle stage, and then the competitiveness of commercial cost and the high-level process control strategies need to be established in a late stage.

By designing API synthetic route based on the structure-activity relationship, the containment process for the highly potent compound has been minimized. The achievement provides us with flexible manufacturing, saving costs/time, reducing workload, and environmental friendly process. (Tetrahedron, 2013, 69, 8564)

Process R&D example; API-cost saving

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

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