Ascendia Pharmaceutical Solutions

Overview

Ascendia Pharmaceutical Solutions is a contract development and manufacturing organization (CDMO) specializing in formulation development, analytical services, and GMP-compliant manufacturing for pharmaceutical and biotechnology companies. The company has been a leading specialty pharma CDMO for over a decade, offering integrated services from pre-formulation through commercialization.

Core Capabilities

Formulation Development & Technologies

• Proprietary nanotechnologies: LipidSol (lipid nanoparticles for encapsulation of small and large molecules), EmulSol (oil-in-water nano-emulsions), AmorSol (amorphic solid dispersion technology), and NanoSol (nano-sized drug particles)
• Pre-formulation screening and development
• Formulation development for multiple dosage forms
• Particle engineering and bioavailability enhancement
• Spray drying and advanced particle engineering
• Controlled-release formulations

Analytical & Development Services

• Analytical method development
• ICH stability studies
• Small-scale formulation support
• Streamlined development pathways

Manufacturing

• GMP and cGMP manufacturing facilities
• Clinical trial material (CTM) manufacturing
• Commercial-scale production
• Class 10,000 (ISO 7) and Class 100 (ISO 5) pharmaceutical manufacturing facilities located in North Brunswick, New Jersey
• Advanced equipment including Precision Nanosystems and GMP-grade NETZSCH DeltaVita 600 Gamma Vita equipment

Specialization

Ascendia specializes in solving bioavailability and solubility challenges for poorly soluble compounds. The company addresses drug development challenges using nanotechnologies and sophisticated processes, with particular expertise in lipid-based drug delivery systems for oral and injectable formulations. All formulation development and manufacturing is conducted in the United States.

Market Position

The company has been named one of the fastest-growing private U.S. companies for four consecutive years, with growth doubling in the past two years. Ascendia operates under a BEST philosophy: Brilliant technology, Excellent service, Superior quality, and Trust.