The Solubility Company Oy is a trusted preclinical contract research organization (CRO). Our mission is to redefine early-stage physicochemical analysis and become the first CRO people turn to for physicochemical measurement in early-stage drug development.
Drug development is a slow and costly process. On average, bringing a new molecular entity (NME) to the market takes 13.5 years and costs USD 0.8B - USD 2.7B. Only 11% of NMEs get through regulatory approval and of those only 30% recover their initial R&D investment. 90% of NMEs in the pipeline have issues with solubility.
At the early stages of drug discovery there are a large number of molecules to be studied, but only small amounts available of each substance. Normally 2-10 mg of material is manufactured when drug discovery projects generate lead compounds in early-stage preclinical drug development. The materials are optimally screened for structure, activity, potency, toxicity, solubility, and morphology.
After potency and toxicity, solubility is arguably the most important property of a substance. Solubility is crucial because a substance that does not dissolve will not enter the bloodstream and cannot be effective in the body. Solubility also effects all subsequent decisions regarding developability of the lead compound. Therefore, information about the solubility of the substance is a critical success factor for drug development. Traditional methods to determine the solubility are not used at this early stage as they require large amounts material.
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