Leveraging decades of experience in peptide manufacturing with our 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 2017).
  • 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
    60 mmol per run (supported by OligoPilot 400 equipment)
  • Oligonucleotide Process Equipment >  allows fully-automated manufacturing at a scale-up to 1800 mmol per batch
  • Downstream Processing Capabilities > for each of the above mentioned process stages, multiple sets are available for streamlined and cost-effective manufacturing

Oligonucleotide API Development & Manufacturing 

  • Process & Analytical Development
  • Range of Small, Medium & Large Equipment
  • Seamless Process Scale-up
  • GMP Manufacturing from 10g to >10kg Batch Size
  • Quality & Regulatory Support

Integrated Supply Chain

  • Cationic Lipids & Carbohydrates for Oligonucleotide Drug Delivery
  • Drug Product – Liquid Vials, Pre-filled Syringes, Lyophilized Products, Clinical Trial Services

Technology Synergies

  • Oligonucleotide Conjugation Expertise
  • Solid-phase & Solution-phase Synthesis
  • MPLC & HPLC, RP & IEX at any scale up to 100 cm
  • Manufacturing Scale-up Expertise
  • Excellent Regulatory & Customer Inspection History