PHARMACEUTICAL CONTRACT MANUFACTURING

As one of the top pharmaceutical contract manufacturing companies in the United States of America, Ascendia Pharmaceuticals® specializes in providing pharma and biotech companies with the expertise and equipment needed to successfully outsource the manufacture and release of products from small-scale clinical trial material supply batches to large-scale final dosage form production runs.

Pharma Contract Manufacturing Company Services

Whether contracting Ascendia for the aseptic processing of parenteral dosage forms, the manufacture of amorphous solid dispersions, or the supply of low oral bioavailability drugs, our biotech and pharma company partners rest assured knowing our highly skilled scientific team has the breadth and depth of experience necessary to deliver rapid, efficient, comprehensive, and flexible manufacturing programs.

Ascendia® houses a state-of-the-art manufacturing facility in its North Brunswick, New Jersey headquarters. It includes sterile manufacturing as well as ISO-5 process and filling room space. The facility is fitted with the latest technology and equipment. Included is a platform to enable the controlled and precise assembly of lipid nanoparticles, as well as machinery for rapid scaling of nanoparticle formulations for late pre-clinical development.

Ascendia’s pharmaceutical contract manufacturing services include:

• FDA- and cGMP-compliant manufacturing practices
• Full-scale lipid nanoparticle manufacturing capabilities
• Analytical method development and quality control testing
• Aseptic (i.e., sterile) and non-sterile manufacturing environments
• Phase 1, Phase 2, and Phase 3 (i.e., clinical and commercial) manufacturing capacities
• Oral solid (e.g., tablet, capsule), semi-solid and semi-liquid (e.g., topical cream, ointment), and liquid (-filled capsule, parenteral injectable) dosage form production abilities
• Lyophilization (e.g., freeze drying), spray drying, hot melt extrusion, and other advanced capabilities available in our Class 10,000 (ISO 7) and Class 100 (ISO 5) USA-based pharmaceutical manufacturing facilities
  
  

The Ascendia Advantage: Your Partner of Choice at Every Phase

Ascendia has become a Partner of Choice with many drug companies during the pre-formation and formulation stages. That expertise — along with our BEST (Brilliant technology, Excellent service, Superior quality, and Trust) philosophy — carries over to our manufacturing processes. 

That proficiency and approach furthers the inherent benefits of using the same outsourcing partner from pre-formulation and discovery through Phase 3 and commercial supply for biotech and pharma companies. We refer to those benefits as the Ascendia advantage, because companies who utilize our services from end to end often realize:

• Faster times to market
• Greater confidence in drug performance
• Lower drug formulation development costs

For drug development projects utilizing lipid nanoparticles (LNPs), Ascendia offers another distinct advantage. We are the ONLY North American CDMO that can provide LNP services from preformulation through Phase 3 and commercial supply. 

Thanks to the exceptional hygienic habits adhered to by our colleagues and careful environmental monitoring (EM), we’ve never had a microbial excursion — but effective pharmaceutical contract manufacturing requires more than just diligent EM. It requires the right equipment and the right partner with the right expertise: it requires Ascendia.