Ascendia Pharmaceuticals
661 US Highway One
North Brunswick, NJ 08902
T: (732) 640-0058
W: www.ascendiapharma.com

 

DELIVERING SOPHISTICATED SOLUTIONS

 Ascendia Pharmaceuticals is a speciality 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 nanoparticle technologies, we can assess the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability. Ascendia formulates products for injection (IV, SC, or IM), transdermal, ophthalmic, or nasal delivery; and both immediate-release and controlled-release products for oral administration. We execute rapid, comprehensive, and cost-effective programs for our clients.

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). Our projects range from discovery-stage molecules, to life-cycle-management projects, to generic product development – always creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.

Our areas of formulation expertise include nanoparticle engineering (milled crystals and solid-lipid particles), stable oil-in-water nanoemulsions (using no organic co-solvents), amorphous solid dispersions (both hot-melt extrusion and spray drying), oral controlled-release (via fluid-bed coating), and production of liposomes.

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 conduct turnkey development of control documentation, and product release requirements as necessary to meet our client’s specifications. We can manufacture sterile, injectable dosage forms in our ISO7/8 cleanrooms, and can process aseptically and/or handle potent compounds using our Compound Aseptic Isolator capability.

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 cyclosporin for dry-eye syndrome. Ascendia has a state-of-the-art pharmaceutical research center located in North Brunswick, NJ, and also operates a formulation research and development facility in Xiamen, China.