Ascendia Pharmaceuticals
Ascendia Pharmaceuticals specializes in the invention and development of specialty pharmaceutical products and novel formulation technologies. We provide formulation, analytical, and manufacturing services to pharmaceutical companies, working collaboratively to provide innovative solutions to challenging drug delivery problems and to create advanced medicines.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Internationally (various countries)
This company also provides solutions for other industrial applications.
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Who We Are
Ascendia is a specialty pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia provides state-of-the-art formulation development services for poorly water soluble molecules, and cGMP manufacture of clinical trial materials. Applying its nano-particle technologies and expertise, Ascendia can rapidly assess the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability. Our technologies include nano-emulsions, amorphous solid dispersions, oral controlled release, self-emulsifying drug delivery systems (SEDDs) and production of nano-particles. Ascendia provides development and testing services – from pre-formulation through to manufacture of pilot clinical supplies.
We execute rapid, comprehensive, and cost-effective programs for our clients. We partner with emerging, discovery-stage pharmaceutical companies to provide early-stage formulations; with generic companies that seek enabling technology fort ANDA development projects; and with specialty pharmaceutical companies that need development of new 505(b)(2) products for clinical testing.
Ascendia’s headquarters, laboratories and manufacturing suites are located in central New Jersey, and the company also has a facility in Xiamen, China to serve formulation development needs of the Chinese market. Ascendia is a privately-held company with a mission to provide customized formulation solutions to salvage difficult compounds and to create advanced medicines to help patients prevail over their disease and enhance their quality of life.
What We Do
CREATING FORMULATIONS FOR POORLY WATER SOLUBLE MOLECULES
Ascendia’s expertise involves finding the most effective method of drug delivery for poorly water soluble molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. We provide practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We provide trial formulations suitable for initial animal studies and toxicology studies using our nano-emulsion, amorphous solid dispersion, controlled release and nano-particle engineering approaches. We conduct pre-formulation testing, formulation approach comparisons, dosage form design and formulation optimization. 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 required to make critical early-stage formulation decisions.
LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT
Ascendia is dedicated to the solubility and bioavailability enhancement of difficult-to-formulate compounds. Our proprietary product development programs focus on creating novel specialty pharmaceutical products that are improved versions of existing medicines. We develop oral, topical and injectable products. We enter into licensing arrangements to co-develop both 505(b)(2) and ANDA products
MANUFACTURE OF cGMP CLINICAL TRIAL MATERIALS
Following formulation selection and optimization, Ascendia can transition a development program quickly to cGMP manufacture of first-in-man clinical materials. Ascendia’s manufacturing capabilities include dosage forms for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulation as it transfers from a pre-clinical phase to early clinical development.