At CORUM, we offer non-GMP and GMP manufacturing at small and commercial scales, from grams up to metric tons, to deliver high quality active pharmaceutical ingredients, regulatory starting materials and early intermediates for preclinical development, clinical batches and drug product commercialization.
We manufacture and provide well characterized drug substances, from gram to kilo, for studies required in the preclinical stage such as in-vitro drug metabolism and interaction, general toxicology and genotoxicity. GLP toxicology lot will be tested and released with validated analytical methods to ensure data accuracy and reliability.
Clinical Batches
Timely delivery of clinical materials is crucial. While meeting your study timeline is our main goal, we also give you ideas and phase-appropriate suggestions for improving product quality and optimizing process to increase yield.
Scalable and robust processes are designed to meet the requirements of critical quality attributes (CQA) of drug substances. Identifying the critical process parameters (CPP) and critical material attributes (CMA) are important to achieving the desired quality outcome. We have excellent track record in delivering active pharmaceutical ingredients and regulatory starting materials at the scale of hundreds of kilogram. Synthetic routes developed in laboratories are modified and optimized by our process engineers to avoid chromatographic purification, extreme reaction temperatures and excessive use of hazardous organic solvents. With the goals of reducing environmental footprint, we utilize hydrogenation reactions when applicable, select greener and less toxic organic solvents and recycle the use of organic solvents to minimize waste output.
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