The CMC study for starting materials of synthetic oligonucleotides drug substance
12 new oligonucleotide drugs(oligonucleotides)were launched globally after 2016,and RNA therapy has gradually become a new promising treatment.The molecular size of oligonucleotides is between small molecules drug and biological drug,and the manufacturing process of oligonucleotides is more complex than traditional small molecule drugs.Oligonucleotides are specifically excluded from the scope of some ICH guidelines(Q3A,Q3B,and Q6),and now there are no specific official guidelines for oligonucleotides'CMC study.This article analyzes a series of technical white papers published by the EPOC,relevant literature,the review reports on marketed synthetic oligonucleotides and discusses the CMC requirements for starting materials of synthetic oligonucleotide drug substances(API),aimed to guide the CMC study of synthetic oligonucleotides in China.
synthetic oligonucleotidesRNA therapystarting materialsdrug regulationCMC study
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