• >> Process Development & Small-scale > scale-up to 10 mmol per run (small-scale equipment can also support early-stage supply)
  • >> Scale-up and Small to Medium-scale > scale up to 100 mmol per run (supported
    by OligoPilotTM equipment)
  • >> Large-scale Oligonucleotide Process Equipment > allows fully-automated manufacturing at
    a scale-up to 1800 mmol per batch (supported by OligoProcessTM equipment)
  • >> Downstream Processing Capabilities > For each of the above-mentioned process stages, multiple sets are available for streamlined and cost-effective manufacturing
  • >> Fully-Integrated service offering > from API to finished dosage and pharmaceutical services

Platform Description

Leveraging decades of experience in peptide manufacturing and the existing wide range of downstream capabilities at multiple facilities,
CordenPharma offers Oligonucleotide process development, scale-up and cGMP manufacturing at multiple scales, supporting early stage
to Phase II / III, (with commercial supply expected by the end of 2024).

Platform Capabilities

  • >> Extensive process and analytical development capabilities in an FDA approved facility
  • >> Development and proof of concept
  • >> Small-scale to mid-scale GMP synthesis capabilities via multiple OligoPilot units (10-100 mmol)
  • >> Larger scale synthesis capabilities via OligoProcess unit
  • >> Extensive downstream processing equipment such as chromatography skids, ultrafiltration equipment and lyophilization

Integrated Supply

CordenPharma’s ability to develop and manufacture a wide range of Bio-Organic APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services. This results in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.