COMPANY DESCRIPTION
Ascendia Pharmaceuticals is a specialty formulation CDMO for biologics and gene deliveries, as well as small molecules. It 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® exceeds customer expectations from pre-formulation through to commercialization. The CDMO is expert in sophis- ticated formulations, as well as cGMP sterile and non-sterile clinical trial and commercial manufacturing. Clients have anointed Ascendia a “Partner of Choice” based upon the successes achieved.
Ascendia’s formulation experts make the Impossible Possible by developing formulations for projects when others have failed. These successful formulations use all GRAS materials to eliminate regulatory burden.
COMPANY BACKGROUND
Founded in 2012, Ascendia offers a comprehensive suite of pre- formulation, formulation development, cGMP manufacturing, and ICH stability services for all dosage forms using proprietary nano-technologies in nanoemulsion, nanoparticles, and amorphous technology platforms. 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 60,000 square-foot 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 formulation development for poorly-soluble molecules and biologics aligns the CDMO with pharmaceutical and biopharmaceutical companies developing new drugs, as well as, new formulations for existing drugs.
PRODUCTS, SERVICES & CAPABILITIES
Ascendia delivers sophisticated formulations to enhance bioavailability and solubility using four proprietary nanotechnologies – AmorSol®, EmulSol®, LipidSol®, and NanoSol®. It develops solutions for all dosage forms for small molecules and biologics, including lipid nanoparticles that encapsulate and deliver gene therapy. 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 trial
Ascendia offers fast, flexible solutions, along with small-batch size services for conducting first-in-man studies efficiently to stay on schedule and within budget.