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 for biologicals 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 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 be an expert in sophisticated formulations, as well as cGMP sterile and non-sterile clinical trial and commercial manufacturing. Many clients have anointed Ascendia a “Partner of Choice” because of the successes it has achieved for them.

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-sq-ft 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, including lipid nanoparticles that enable 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, and small-batch size services for conducting first-in-man study efficiently to stay on schedule and within budget.