Oligonucleotide Characterization and Analysis

Characterization and Analysis of oligonucleotide products to assess identity, quality, structure, and physicochemical properties

What are Oligonucleotides?

The first oligonucleotide approved by the US FDA was Novartis Pharmaceutical’s Vitravene (formiversen) in 1998, although this was subsequently discontinued in 2004 due to lack of clinical need. Currently, there are only 8 FDA-approved oligonucleotide-based therapeutics on the market, however there are hundreds more in the clinical pipeline, from antisense oligonucleotides (AON) and small interfering RNA (siRNA) to full-length messenger RNA (mRNA) for gene therapy and vaccine applications

What are the manufacturing challenges?

Oligonucleotide Regulatory View

Characterization of Oligonucleotides

Are you developing an oligonucleotide product?