Ascendia Pharmaceuticals
661 US Highway One, Unit B
North Brunswick, NJ 08902
T: 732.640.0058
E: bd@ascendiapharma.com
W: www.ascendiapharma.com

 

Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile and non-sterile enabling formulations and manufacturing, along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs, nutraceuticals, and animal health.

Ascendia has invested heavily in drug delivery nanotechnologies that aid in large and small molecule formulations, as well as biologics. The specialty CDMO is expanding its talented people, capabilities, and facilities to exceed customer expectations from early to late stage development. Many clients have anointed Ascendia as a “Partner of Choice” because of the successes achieved for them.

Making Insoluble Soluble

Founded in 2012, Ascendia makes the Insoluble Soluble through a comprehensive suite of pre-formulation, formulation development, manufacturing, and stability services for parental, oral, opthalmic, 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).

Delivering Sophisticated Formulations 

Ascendia delivers sophisticated formulations to enhance bioavailability and solubility using three proprietary nanotechnologies – NanoSol®, EmulSol®, and AmorSol®. These serve as the cornerstones to developing solutions for all dosage forms including small molecules and biologics that may not have been achieved otherwise.

Manufacture of Clinical Trial Materials

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 manufactures cGMP batches for orally administered dosage forms. It also provides cGMP manufacture of sterile, injectable dosage forms.

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. By offering fast, flexible, and small-batch size services for conducting first-in-man study, Ascendia helps drug development teams stay on schedule and within budget.