Removal of dsRNA byproducts using affinity chromatography

Double-stranded RNA (dsRNA) molecules are immunogenic byproducts of in vitro transcription of single-stranded RNA (ssRNA). Removal of dsRNA from ssRNA is difficult because the byproducts have similar sizes, sequences, and charges to the desired ssRNA. Here, we describe a dsRNA-specific affinity resi...

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Main Authors: Nathaniel E. Clark, Mateusz Kozarski, Sinem Demirel Asci, Jurgen Van den Heuvel, Matt R. Schraut, Roger A. Winters, Kelley Kearns, Thomas C. Scanlon, Senne Dillen
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Molecular Therapy: Nucleic Acids
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Online Access:http://www.sciencedirect.com/science/article/pii/S2162253125001039
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author Nathaniel E. Clark
Mateusz Kozarski
Sinem Demirel Asci
Jurgen Van den Heuvel
Matt R. Schraut
Roger A. Winters
Kelley Kearns
Thomas C. Scanlon
Senne Dillen
author_facet Nathaniel E. Clark
Mateusz Kozarski
Sinem Demirel Asci
Jurgen Van den Heuvel
Matt R. Schraut
Roger A. Winters
Kelley Kearns
Thomas C. Scanlon
Senne Dillen
author_sort Nathaniel E. Clark
collection DOAJ
description Double-stranded RNA (dsRNA) molecules are immunogenic byproducts of in vitro transcription of single-stranded RNA (ssRNA). Removal of dsRNA from ssRNA is difficult because the byproducts have similar sizes, sequences, and charges to the desired ssRNA. Here, we describe a dsRNA-specific affinity resin that selectively removes dsRNA from ssRNA. Affinity purification reduced dsRNA levels by >100-fold, to as low as ∼0.00007% w/w of total mRNA, with no negative impact on RNA integrity. The purified RNA, synthesized with standard nucleotides, induced no inflammatory response in a reporter cell line assay designed to measure innate immune responses. Purified RNA induced greater protein expression and healthier cells. The immunogenicity of the affinity-purified RNA with standard nucleotides compares favorably to RNA synthesized with modified nucleotides and purified with cellulose or reverse-phase high-performance liquid chromatography (HPLC). dsRNA affinity purification provides a facile and scalable solution to the problem of immunogenic dsRNA byproducts in transcribed RNA. This approach will improve quality and safety of RNA vaccines and therapeutics.
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series Molecular Therapy: Nucleic Acids
spelling doaj-art-6eb3bbe4e43b455f858d40e11da44ebd2025-08-20T02:58:34ZengElsevierMolecular Therapy: Nucleic Acids2162-25312025-06-0136210254910.1016/j.omtn.2025.102549Removal of dsRNA byproducts using affinity chromatographyNathaniel E. Clark0Mateusz Kozarski1Sinem Demirel Asci2Jurgen Van den Heuvel3Matt R. Schraut4Roger A. Winters5Kelley Kearns6Thomas C. Scanlon7Senne Dillen8Repligen, 16 Cavendish CT, Lebanon, NH 03766, USA; Corresponding author: Nathaniel E Clark, Repligen, 37 Cavendish CT, Lebanon, NH 03766, USA.etherna, Galileilaan 19, 2845 Niel, Belgiumetherna, Galileilaan 19, 2845 Niel, Belgiumetherna, Galileilaan 19, 2845 Niel, BelgiumRepligen, 16 Cavendish CT, Lebanon, NH 03766, USARepligen, 16 Cavendish CT, Lebanon, NH 03766, USARepligen, 16 Cavendish CT, Lebanon, NH 03766, USARepligen, 16 Cavendish CT, Lebanon, NH 03766, USAetherna, Galileilaan 19, 2845 Niel, Belgium; Corresponding author: Senne Dillen, etherna, Galileilaan 19, 2845 Niel, Belgium.Double-stranded RNA (dsRNA) molecules are immunogenic byproducts of in vitro transcription of single-stranded RNA (ssRNA). Removal of dsRNA from ssRNA is difficult because the byproducts have similar sizes, sequences, and charges to the desired ssRNA. Here, we describe a dsRNA-specific affinity resin that selectively removes dsRNA from ssRNA. Affinity purification reduced dsRNA levels by >100-fold, to as low as ∼0.00007% w/w of total mRNA, with no negative impact on RNA integrity. The purified RNA, synthesized with standard nucleotides, induced no inflammatory response in a reporter cell line assay designed to measure innate immune responses. Purified RNA induced greater protein expression and healthier cells. The immunogenicity of the affinity-purified RNA with standard nucleotides compares favorably to RNA synthesized with modified nucleotides and purified with cellulose or reverse-phase high-performance liquid chromatography (HPLC). dsRNA affinity purification provides a facile and scalable solution to the problem of immunogenic dsRNA byproducts in transcribed RNA. This approach will improve quality and safety of RNA vaccines and therapeutics.http://www.sciencedirect.com/science/article/pii/S2162253125001039MT: Oligonucleotides: Therapies and Applicationsdouble-stranded RNAmessenger RNAcircular RNAself-amplifying RNAin vitro transcription
spellingShingle Nathaniel E. Clark
Mateusz Kozarski
Sinem Demirel Asci
Jurgen Van den Heuvel
Matt R. Schraut
Roger A. Winters
Kelley Kearns
Thomas C. Scanlon
Senne Dillen
Removal of dsRNA byproducts using affinity chromatography
Molecular Therapy: Nucleic Acids
MT: Oligonucleotides: Therapies and Applications
double-stranded RNA
messenger RNA
circular RNA
self-amplifying RNA
in vitro transcription
title Removal of dsRNA byproducts using affinity chromatography
title_full Removal of dsRNA byproducts using affinity chromatography
title_fullStr Removal of dsRNA byproducts using affinity chromatography
title_full_unstemmed Removal of dsRNA byproducts using affinity chromatography
title_short Removal of dsRNA byproducts using affinity chromatography
title_sort removal of dsrna byproducts using affinity chromatography
topic MT: Oligonucleotides: Therapies and Applications
double-stranded RNA
messenger RNA
circular RNA
self-amplifying RNA
in vitro transcription
url http://www.sciencedirect.com/science/article/pii/S2162253125001039
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