Ascendiacdmo

Overview

Ascendia Pharmaceutical Solutions is a contract development and manufacturing organization (CDMO) providing comprehensive services from pre-formulation through commercialization. The company specializes in solving complex drug delivery challenges using proprietary nanotechnologies and sophisticated formulation approaches.

Core Capabilities

Formulation & Technologies:

• Four patented nanotechnologies: LipidSol (lipid nanoparticles), EmulSol (nano/micro-emulsions), AmorSol (amorphous solid dispersions), and NanoSol (nano-sized particles)
• Pre-formulation and formulation development for poorly soluble compounds
• Bioavailability enhancement and controlled/modified release dosage forms
• Self-Emulsifying Drug Delivery Systems (SEDDS)
• Long-acting injectables and lyophilized products

Manufacturing:

• Full-spectrum cGMP and GMP manufacturing for clinical trial materials and commercial supply
• Sterile injectables and oral solid dosage forms
• Nanoparticle formulations and lipid-based drug delivery systems
• Aseptic and non-aseptic manufacturing capabilities
• Support from IND-enabling batches through Phase 1–3 manufacturing

Analytical Services:

• ICH stability studies
• Small-scale formulation support
• Analytical method development
• Regulatory documentation preparation

Quality & Compliance

Ascendia operates under comprehensive cGMP quality systems with electronic quality management (QMS) implementation. The company's U.S.-based facilities in the New Jersey Bioscience Center are designed for FDA compliance and undergo frequent client audits and internal quality assessments. All formulation development and manufacturing is conducted in the U.S.

Business Model

Unlike conventional drug delivery technology companies, Ascendia operates on a straightforward fee-for-service CDMO model without technology access fees or royalties, while providing clients access to its proprietary nanotechnology platforms.