Oligonucleotides represent a class of synthetic nucleic acid polymers, typically consisting of single- or double-stranded molecules with around 20 nucleotides. They are utilized for modulating gene expression through various mechanisms, including antisense oligonucleotides (“ASO”), RNA interference (“RNAi”), and aptamers, among others. These oligonucleotide based therapies encompass several major types, such as RNAi, ASO, small interfering RNA (“siRNA”), short hairpin RNA (“shRNA”), double-strand RNA (“dsRNA”), piwi-interacting RNA (“piRNA”), phosphorodiamidate morpholino oligonucleotides (“PMO”) and cytosine phosphorothioate-guanine (“CpG”) oligonucleotides. With key technologies breakthroughs in delivery technology, oligonucleotide is becoming a fast-growing drug modality. In the meantime, oligonucleotide drugs are facing a series of challenges during the commercialization process, including lack of diverse synthesis process, low synthesis efficiency, insufficient manufacturing capacity, high waste generation and high production cost.
Leveraging our deep industry insights, established R&D and manufacturing capabilities, and premium reputation among customers, we have expanded our CDMO solutions to oligonucleotides. Much like peptides, oligonucleotide therapy demands expertise in solid-phase synthesis and protecting group chemistry. Our downstream processing includes purification via chromatography, ultrafiltration/permeation, precipitation, and lyophilization, following the same fundamental principles as peptide API production, in which we boast substantial strength and experience.
We have capabilities in producing various types of oligonucleotides, including but not limited to ASO, with various modification, such O-methoxyethyl, locked nucleic acids (“LNA”) and O-ethyl, siRNAs with various modification, such as O-methylation, F, vinylphosphate and conjugates, PMO, peptide nucleic acids (“PNAs”), miRNAs, aptamers, CpGs and decoys. Recognizing the unique challenges posed by fully automated oligonucleotide synthesis, we prioritize rigorous quality control of starting materials. To this end, we have established comprehensive databases for both starting materials and oligonucleotide products. These initiatives are geared towards expediting process development, mitigating risks, ensuring consistency, and streamlining the drug development timeline.
