COMPANY DESCRIPTION
Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile and non-sterile enabling formulations along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs and nutraceuticals.
Ascendia is expanding its people, capabilities, and facilities to meet and exceed customer expectations from early to late state development. This investment allows Ascendia to continue to be an expert in poorly soluble molecules. Many clients have anointed Ascendia a “Partner of Choice” because of the successes it has achieved for them.
COMPANY BACKGROUND
Founded in 2012, Ascendia makes the insoluble soluble through a comprehensive suite of pre-formulation, formulation development, manufacturing, and stability services for parenteral, oral, and topical dosage forms. The company built its foundation of success on its customer-centric culture that exudes its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust).
MARKETS SERVED/FACILITIES
Headquartered in North Brunswick, NJ, Ascendia’s facility has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms, as well as Class 10,000 (ISO 7) manufacturing suites. Ascendia’s expertise in discovering the most effective method of drug delivery for poorly water-soluble molecules and biologics aligns the CDMO with pharmaceutical and biopharmaceutical companies developing new drugs, as well as formulations for existing drugs for new uses.
PRODUCTS, SERVICES & CAPABILITIES
Ascendia delivers sophisticated formulations to enhance bioavailability and solubility using three proprietary nanotechnologies – NanoSol®, EmulSol®, and AmorSol®. It develops solutions for all dosage forms for small molecules and biologics. Its facility maintains stability chambers for conducting non-GMP and cGMP stability studies in accordance with ICH guidelines. Ascendia stability studies:
- determine robustness of formulation prototypes during early development
- ascertain chemical and physical integrity of lead formulations before advancement into animal/toxicology studies
- assure final formulations meet stability for clinical trials
Ascendia recognizes the challenge in developing parenteral dosage forms and specializes in early-stage development services for these projects. A major milestone in a pharmaceutical development project is the first-in-man study. This vital achievement is difficult for parenteral products due to the expense of producing clinical trial materials. Ascendia offers fast, flexible, and small-batch size services for conducting first-in-man study efficiently to stay on schedule and within budget.