OLIGONUCLEOTIDES

Oligonucleotides

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 commercial manufacturing at multiple scales, supporting early stage to Phase II / III, and commercial supply.

  • >> Process Development & Small-scale > scale-up to 10 mmol per run (small-scale equipment can also support early-stage supply)
  • >> Scale-up & 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 10 g to > 10 kg Batch Size
  • >> Quality & Regulatory Support

Integrated Supply Chain

  • >> Cationic Lipids & Carbohydrates for Oligonucleotide Drug Delivery (e.g. GalNac)
  • >> Drug Product – Oligonucleotide fill and finish including 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

Integrated Supply

CordenPharma’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs), Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.


Related Facilities & Platforms

Technology Platforms