About

About Ascendia Pharmaceutical Solutions Ascendia Pharmaceutical Solutions specializes in complex formulation development and manufacturing of pharmaceutical and biologic products using a suite of 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. CREATING FORMULATIONS FOR CHALLENGING MOLECULES Ascendia’s expertise involves finding the most effective method of drug delivery for poorly soluble and/or bioavailable molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. Ascendia provides practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We create trial formulations suitable for PK and tox studies using our nano-emulsion, amorphous solid dispersion, controlled release, LNP and other nanoparticle engineering approaches. We conduct preformulation 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. cGMP MANUFACTURING Following formulation selection and optimization, Ascendia can quickly transition a development program to cGMP manufacturing of first-in-man clinical materials. With both aseptic and non-aseptic manufacturing suites in its New Jersey (USA) facility, the company can handle various dosage forms, including those for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulations advancing from preclinical to clinical stages of development. LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT Ascendia is dedicated to the solubility, bioavailability and stability 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 for clients via the 505(b)(2) NDA pathway, as well providing formulation development and manufacturing for complex generic (ANDA) products.