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 nano-particle 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 nano-particle engineering (milled crystals and solid-lipid particles), stable oil-in-water nano-emulsions (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, and work with potent compounds, using our ISO7/8 cleanrooms and aseptic isolator capabilities.

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 nano-emulsion form of cyclosporin for dry-eye syndrome.  Ascendia has a state-of-the-art pharmaceutical research, development, and manufacturing center located in North Brunswick, NJ.