Resource Library
Optimized residual dsRNA detection for mRNA therapeutics
Accurate double-stranded RNA (dsRNA) detection is essential for mRNA-based therapeutics and vaccines. In this whitepaper, we explore how our enhanced enzyme-linked immunosorbent assay (ELISA) technology overcomes traditional challenges to provide effective solutions for superior dsRNA quantification. Read more
Critical quality attributes for mRNA drug substances
Most mRNA therapeutics and vaccines are synthesized through in vitro transcription from DNA templates. During this process, dsRNA can be inadvertently produced as a by-product. This form of RNA, particularly when derived from a virus, is highly immunogenic; it activates several intracellular and endosomal sensors that can trigger inflammation, halt protein synthesis, and even lead to cell death. Consequently, controlling residual dsRNA levels is critical in ensuring the safety and effectiveness of mRNA-based drugs. Global regulatory bodies have set stringent standards mandating that dsRNA concentrations remain below 0.01% in mRNA drug substances, underscoring its significance as a critical quality attribute for RNA-based drugs.
dsRNA detection with custom ELISA technology
The immunoblot method has long been a standard approach for detecting dsRNA in mRNA production. While it offers simplicity and ease of use, this method has significant limitations in terms of sensitivity. To ensure greater accuracy and reliability in mRNA therapeutics development, Samsung Biologics has developed a superior ELISA-based method for dsRNA detection, offering significant advantages over traditional commercial ELISA kits. These improvements specifically address limitations observed in commercial ELISA kits, particularly the matrix effects that can skew dsRNA measurements in mRNA drug substances.
Accurate double-stranded RNA (dsRNA) detection is essential for mRNA-based therapeutics and vaccines. In this whitepaper, we explore how our enhanced enzyme-linked immunosorbent assay (ELISA) technology overcomes traditional challenges to provide effective solutions for superior dsRNA quantification. Read more
Critical quality attributes for mRNA drug substances
Most mRNA therapeutics and vaccines are synthesized through in vitro transcription from DNA templates. During this process, dsRNA can be inadvertently produced as a by-product. This form of RNA, particularly when derived from a virus, is highly immunogenic; it activates several intracellular and endosomal sensors that can trigger inflammation, halt protein synthesis, and even lead to cell death. Consequently, controlling residual dsRNA levels is critical in ensuring the safety and effectiveness of mRNA-based drugs. Global regulatory bodies have set stringent standards mandating that dsRNA concentrations remain below 0.01% in mRNA drug substances, underscoring its significance as a critical quality attribute for RNA-based drugs.
dsRNA detection with custom ELISA technology
The immunoblot method has long been a standard approach for detecting dsRNA in mRNA production. While it offers simplicity and ease of use, this method has significant limitations in terms of sensitivity. To ensure greater accuracy and reliability in mRNA therapeutics development, Samsung Biologics has developed a superior ELISA-based method for dsRNA detection, offering significant advantages over traditional commercial ELISA kits. These improvements specifically address limitations observed in commercial ELISA kits, particularly the matrix effects that can skew dsRNA measurements in mRNA drug substances.