Ascendia Pharmaceutical Solutions

Overview

Ascendia Pharmaceutical Solutions is a specialty contract development and manufacturing organization (CDMO) providing comprehensive solutions from pre-formulation through commercialization. The company has been a leading specialty pharma CDMO for over a decade, with all formulation development and manufacturing conducted in the U.S.

Core Capabilities

Formulation & Development Services

• Formulation development with expertise in various dosage forms and drug delivery technologies
• Analytical services including physicochemical property assessment, stability testing, and performance characterization using spectroscopy, chromatography, and imaging
• Process optimization and scale-up studies to improve efficiency and product quality
• Preclinical testing and Phase 1 manufacturing with cGMP compliance

Manufacturing & Technologies

• Addresses bioavailability and stability challenges through micronization, nanoparticle formulation, and complexation techniques
• Dosage form development including tablets, capsules, and injectables
• Scalable and reproducible manufacturing processes compatible with commercial production
• Four patented technologies utilizing GRAS materials

Regulatory Support

• In-depth knowledge of regulatory requirements for pharmaceutical development and manufacturing
• Assistance with regulatory submissions, stability studies, and navigation of complex regulatory landscapes
• cGMP compliance for Phase 1 investigational drugs with clear written procedures, well-controlled equipment, and accurate manufacturing/testing data

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 positions itself as a partner that overcomes drug development challenges through nanotechnologies and sophisticated processes, serving pharmaceutical and biological companies developing small molecules, biologics, and gene delivery products.