Benefit from our Experience and Expertise

Avecia is the oldest established oligonucleotide Contract Manufacturing Organization (CMO).

We have extensive experience in oligonucleotide manufacture; we have prepared over a thousand sequences, and have scaled up hundreds for large scale cGMP supply. We have available capacity to supply of hundreds of kilograms per year.

Our regulatory track record is excellent. We have undergone three successful FDA inspections. The latest of these, a Pre-approval Inspection (PAI) in April 2006, resulted in no 483’s, no observations and no points of discussion. We are audited by approximately twenty clients per year and we have been audited by and approved by six of the world’s top ten pharmaceuticals companies.

We are experienced in supply through all phases of clinical trials. We have a high degree of familiarity with the regulatory journey from preclinical supply to pre-commercial launch, and have developed expertise in supply chain management, and analytical and process development, which we use to transition our customer’s compounds through the changing needs along the drug development journey. In culmination of the regulatory journey we have successfully completed numerous oligonucleotide process validations.