Syngene’s Oligonucleotide capacity & services ranges from development to cGMP manufacturing of chemically synthesized high quality modified and non-modified custom Oligonucleotide (DNA/RNA), siRNA (single & double stranded, miRNA (modified and non-modified), Antisense, fast delivery of Oligonucleotides at various scales.
A highly qualified & experienced team is focused in establishing the technology platform for process development, manufacturing and analytical ensuring global client requirements. We have partnered with various clients’ globally for long term alliances and programs.
Our development & cGMP scale ranges from:
Development facility (NGMP)
Syngene’s development facility is equipped with world class AKTA Oligopilot 100, a fully automated synthesizer of regular and modified Oligonucleotides (chemically synthesized DNA/RNA, siRNA, Antisense, Aptamer, miRNA, Oligopeptide conjugates) catering to Research & Development work.
Scale of synthesis: 250 micromoles to 6 millimoles (1gms to 25 gms) & sequence length of 10 to 30 mer.
Manufacturing facility (cGMP)
Syngene has a state-of-the -art facility for its cGMP manufacturing of various class of Oligonucleotides. The facility comprises of total area of 1500 sq.ft. fully equipped with world class GE make Oligopilot 400, capable of manufacturing GMP grade chemically synthesized regular and modified Oligonucleotides (DNA/RNA, siRNA, Antisense, Aptamer, miRNA, Oligopeptide conjugates) for Tox studies & Clinical trials.
Scale of synthesis: 4 mmol to 45 mmol* (12 g to 120 g) with a sequence length of 10 to 30 mer.
Syngene also in houses the complete analytical support for developed /manufactured Oligonucleotide
- Method transfer to/from client
- Full set of in-process and lot release method development
- Product characterization
- Method qualification for release of toxicology or early phase clinical studies
- Method validation