Endo Contract Manufacturing:
Fermentation Processing

Horsham, Pennsylvania

Our Experience and Expertise

  • Manufacturing facility in Horsham, Pennsylvania
  • Development and tech transfer: clinical through commercial
  • FDA, EMA, Health Canada, ANVISA inspected
  • Well-established cloud-based quality systems
Office Workers

Product and Processing Capabilities

Biopharmaceutical Bulk Drug Substance Production Facility

  • Biosafety Level 2
  • Protein and enzyme production
    • Secreted peptides/Low molecular weight proteins
    • Non-engineered proteins
    • Recombinant proteins
    • Glycosylated proteins
    • Enzymes
    • Vaccines
    • Cell banking

Fermenters/Bioreactors up to 500 L (Aerobic and Anaerobic)

  • Bacterial fermentations
  • Fungal fermentations
  • Insect cell cultures


  • Cytiva ÄKTAprocess and ÄKTA Pilot chromatography systems
  • Cytiva AxiChrom and BPG chromatography columns
  • Millipore tangential flow filtration systems

Holding and mixing vessels up to 1,000 L

Cold Storage

Horsham equipment

Quality Control and Analytical Testing Capabilities

Release and stability testing: drug substance, drug product, sterile diluent

Biologic and chemical assays: drug product, API, raw materials

  • High-performance liquid chromatography (HPLC), including size exclusion (SEC)
  • Reverse phase purity/impurity methods
  • Peptide mapping
  • UV/VIS spectroscopy
  • Karl Fischer moisture content
  • SDS-PAGE and densitometry
  • Imaged capillary electrophoresis (iCE)
  • Capillary gel electrophoresis (CGE)
  • Microplate- and cuvette-based enzyme activity assays
  • NIR and FTIR
  • Inductively coupled plasma mass spectrometry (ICP-MS)
  • Wide range of wet chemistry analysis including pH, conductivity, titrations, osmometry


  • Total organic carbon (TOC) analysis using Sievers M9, endotoxin
  • Kinetic chromogenic (water and in-process)
  • Bioburden via membrane filtration (water and in-process)
  • Conductivity
  • Microbial identification
  • Cell line characterization
  • Microbial testing of upstream processes (culture purity, hemolytic testing)

Want to learn more? Get in touch!

Pearse Kelly, 484-216-2812, kelly.pearse@endo.com

Horsham Lab