Ascendia Pharmaceuticals is a speciality contract development and manufacturing (CDMO) organization dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical-stage drug candidates. We specialize in developing formulation solutions for poorly-water soluble molecules and other challenging pharmaceutical development projects. Combining our extensive knowledge and experience of formulation capabilities with our suite of nano-particle technologies, we can assess the feasibility of a broad array of robust formulation options to improve a drug’s bioavailability. Thusly decreasing the amount of drug and the number of injections, as well as, greatly reducing in some cases the daily pill-burden from 20 to 4. Ascendia’s expertise spans across (IV, SC, or IM), injection, ophthalmic, transdermal, nasal delivery, along with immediate and controlled-release products for oral administration and complex generics. We execute rapid, comprehensive, and cost-effective programs for our clients and partners that exceed expectations.
Ascendia provides turn-key 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 (NCEs), to life-cycle management projects (505b2s).
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), liquid-fill, hard capsules and liposome production.
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 oral, topical, and sterile dosage forms, using our ISO 5/7/8 cleanrooms and isolator capabilities. We work with controlled-substance and 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 Co-Development and out-licensing, including ASD-005, ASD-002, the first in man injectable formulations that fulfill unmet market needs in the acute care space of the anti-thrombotic drug clopidogrel, (that may be used in the same acute-care patient) and ASD-004, the next-generation improved nano-emulsion cyclosporin for dry-eye syndrome. Ascendia has a state-of-the-art pharmaceutical research, development, and manufacturing center located in North Brunswick, NJ. Call us now to see how we can enhance your product pipeline!
Posted Date: 12/2/2020
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