Ascendia

Ascendia Pharmaceuticals is a specialty contract development and manufacturing (CDMO) company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. We specialize in creating formulation solutions for poorly water-soluble molecules and other challenging pharmaceutical development projects. Using our suite of formulation capabilities and nano-particle technologies, we can assess the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia formulates products for injection (IV, SC or IM); transdermal, opthalmic or nasal delivery; and both immediate-release and controlled-release products for oral administration. Ascendia provides complete development services - analytical testing/validation; pre-formulation development and modeling; formulation proof-of-concept, development, and optimization; and cGMP manufacturing/release of clinical trial materials (CTM). We provide contract cGMP manufacturing services for our clients, quickly transitioning projects from formulation optimization to proof-of-concept for a first-in-man study. We execute rapid, comprehensive, and cost-effective programs for our clients. Our areas of formulation expertise include nano particle engineering (milled crystals, amorphous nanoparticles, and lipid-based nanoparticles), stable oil-in-water nano-emulsions, amorphous solid dispersions (both hot-melt extrusion and spray drying), oral controlled-release (via fluid-bed coating), and production of liposomes. Ascendia also has developed and patented a proprietary pipeline of pharmaceutical product candidates for out-licensing, including ASD-002, a novel, injectable form of the anti-thrombotic drug clopidogrel, and ASD-004, an improved nanoemulsion form of cyclosporine for dry-eye syndrome.