Chemistry, Manufacturing, and Controls for Synthetic Oligonucleotide Therapeutics
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C Duan, B Wong
Medical Regulatory Affairs
taylorfrancis.com
The field of synthetic oligonucleotide therapeutics has undergone remarkable progress, transitioning from scientific curiosity to clinical reality (Khvorova and Watts, 2017). As of early 2024, there are 16 approved synthetic oligonucleotide drugs spanning various classes such as antisense oligonucleotides, Small Interfering RNAs (siRNAs), aptamers, and immunostimulatory oligonucleotide adjuvants (Ejebe et al., 2017; Yanik et al., 2021). These molecules have demonstrated their potential to address diverse therapeutic areas, including …
