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Phase-appropriate development helps drug developers balance speed, risk, and investment, but early decisions can create challenges later. Learn where a longer-term perspective can prevent today’s choices from becoming tomorrow’s manufacturing limitations.
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Follow a compound through a full IND development cycle, from modifications to the synthetic route through formulation development and API manufacturing, and see how each stage supports submission.
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Sponsors spend considerable time and resources on process development and validation to create a launch-ready manufacturing process, which might require refinement. More often, significant process refinement is needed when adding CDMOs in preparation for process validation and commercial launch.
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The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.
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Anmaris Torres, Process Engineering Team Leader, on why a process transfer starts with a conversation across departments to figure out how to cut cycle time before commercial production begins.
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Cambrex's highly skilled team of chemists and process engineers, combined with a science-driven project management approach, ensures seamless execution at every stage.
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