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Developing oligonucleotide drug terminal sterilisation processes

A report on the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.

European medicines agencyEuropean pharma oligonucleotide consortiumMedicines agencyMedicinal productPrimary containerNucleic acid therapeuticsand

FDA Releases Draft Guidance On CMC For Individualized ASO Therapies

A new FDA guidance released in Dec. 2021 acknowledges the difficulties inherent in manufacturing individualized antisense oligonucleotide (ASO).

Brown rudnickNeil dispiritoAdamm schoenWilliamf kiesmanXiulong shenRobert simlerBenjamin andrewsRobertb ruhSyminj charpentierDrug administrationNucleic acids researchEuropean pharma oligonucleotide consortiumControls recommendationsGuidance forSeverely debilitatingLife threatening diseases

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