RAPID DEVELOPMENT THROUGH PHASE I CTM
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies. At Ascendia, our core business is to develop practical, customized product formulations for poorly water soluble drugs. We offer rapid and cost-effective formulation technology screening services through the utilization of our multiple nano-particle technology platforms. By working with Ascendia, our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time and cost to make critical early-stage formulation decisions. Ascendia provides both the development and testing services – creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.
By partnering with Ascendia our clients can reduce the time required to develop a suitable formulation, especially for a drug with solubility issues. We strive to create a formulation prototype with enhanced biopharmaceutical properties suitable for meaningful animal PK and toxicology studies – the same formulation is then ready for production of GMP supplies for a first-in-man study. Our technologies are established in the industry and can quickly move to registration batches without a regulatory approval concern regarding the formulation process.
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