Preclinical PR&D: Provision of a Robust Route for Preclinical Supply and to Facilitate Clinical Supply

Preclinical PR&D Provision of a Robust Route for Preclinical Supply and to Facilitate Clinical Supply

• UK Biotech company
• Supported by 3 FTEs for 6 months
• 300 g of API provided
• Route developed to avoid an unstable intermediate and remove all chromatography
• Overall yield of route increased from 3% to 16%
• New key starting material identified, 9-times cheaper than original starting material
• Technology transfer package and follow-on support provided to cGMP manufacturer

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