Dr. Xufeng Sun, VP, manufacturing science and technology at Sharp, discusses how carefully mapping lyophilisation cycles and meticulous fill finish studies help bring oligonucleotide therapies to patients seamlessly.
How the development pipeline for oligonucleotide therapies continues to expand rapidly, growing from three FDA- or EMA-approved treatments in 2015 to 20 by 2024. Using engineered single- or double-stranded nucleic acid polymers, these therapies precisely target RNA and, in some cases, DNA within cells. By inducing degradation, blocking protein translation or modulating splicing events, oligonucleotide therapies offer a way to overcome disease-causing gene expression with minimal side effects.