ABOUT ASCENDIA PHARMA
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.
We provide formulation, analytical, and manufacturing services to pharmaceutical and biopharmaceutical companies. Ascendia works collaboratively to provide innovative solutions to challenging drug delivery problems and create advanced medicines.
CREATING FORMULATIONS FOR POORLY WATER SOLUBLE MOLECULES
Ascendia makes the Insoluble Soluble by delivering sophisticated formulations to enhance bioavailability and solubility using its three proprietary nanotechnologies – NanoSol®, EmulSol®, and AmorSol®. 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).
Our practical, customized formulation solutions 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. Many clients have anointed Ascendia as a “Partner of Choice” because of the successes achieved for them.
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 pharmaceutical and biopharmaceutical companies who seek a CDMO partner for their formulation as it transfers from a pre-clinical phase to early clinical development.
More Than a CDMO for Biologics
As a specialty CDMO, Ascendia has invested heavily in drug delivery nanotechnologies that aid in biologics, as well as other large and small molecule formulations. The versatility of EmulSol, NanoSol, and AmorSol helps Ascendia successfully address almost all new compounds with different challenging properties, including biologicals, to help make the Impossible Possible.