This whitepaper explores Ardena’s strategic methodology for addressing the challenges in synthesizing highly potent compounds (HPAPI) during early drug development. Emphasizing a rational risk-based approach, the paper outlines key factors in achieving safety, efficiency, and compliance with regulatory standards. The methodology includes continuous risk assessment, facility design based on Occupational Exposure Bands (OEB), and a phased strategy for drug synthesis. With a focus on Quality by Design (QbD) principles, the approach ensures scalability and optimization, allowing for rapid adaptation as more safety data become available. This methodology positions organizations for success in drug development, providing an integrated platform for synthesis and manufacturing from pre-clinical to clinical stages.

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