Navigating The Analytical Complexity Of Oligonucleotide Therapeutics

By William Boomershine, Ph.D.

Oligonucleotides are gaining widespread use in the biopharmaceutical industry, serving as both therapeutics and vaccines. These molecules range from small interfering RNAs (siRNA) and microRNAs (miRNA) to larger plasmid DNAs (pDNA) and messenger RNA (mRNA) vaccines. While siRNA and miRNA are considered complex small molecules, the size and complexity of pDNA and mRNA create significant analytical challenges. Comprehensive testing is required to ensure the identity, integrity, and purity of these products. Plasmid DNA must be expressed, purified, and properly supercoiled to facilitate mRNA transcription, which is then capped and polyadenylated. For mRNA to be functional, effective delivery into cells is crucial, often achieved through lipid nanoparticles (LNPs), further complicating the final drug product’s analysis.

Alcami Corporation recognizes the complexity of oligonucleotide analysis and has invested in advanced instrumentation to fully support the testing of these products. With extensive experience and cutting-edge technology, Alcami offers comprehensive solutions tailored to meet your needs and timelines, from identity and purity testing using chromatography and electrophoresis to PCR and microbial studies.