Ensuring Safety Through Precise Residual Host Cell RNA Quantification

During upstream and downstream processing, genetic materials - particularly RNA - from production host cells (e.g., E. coli, HEK293) may persist in the final drug substance. These impurities, even at trace levels, pose potential immunogenicity risks and may interfere with product stability and function. As such, regulatory agencies including the FDA and EMA emphasize the importance of monitoring residual nucleic acids as part of impurity profiling and product release criteria.

Residual host cell RNA, if not adequately removed during purification, may elicit unintended immune responses, such as Toll-like receptor (TLR) - mediated inflammation. The rising complexity of modalities such as viral vectors, mRNA therapeutics, and engineered cell therapies necessitates stringent nucleic acid control strategies.

Furthermore, residual RNA may also impact downstream assays or therapeutic performance, especially in gene and cell therapies where nucleic acid-based components are integral. Accurate quantification is therefore essential for risk assessment, regulatory compliance, and ensuring product safety.

Quantitative reverse transcription PCR (RT-qPCR) are commonly employed methods for detecting residual host cell RNA in biological products. qPCR is widely regarded as the gold standard for for residual RNA quantitation due to its high sensitivity (down to picogram levels), sequence specificity, and quantitative accuracy. qPCR allows for the targeted detection of host cell-specific RNA sequences, providing a robust means of validating RNA clearance during purification.

SHENTEK has successfully developed the Residual E.coli RNA Quantitation Kit (2G), which integrates reverse transcription and fluorescent probe-based qPCR detection technology to enable one-step quantitative detection of host cell RNA from E. coli in a variety of biopharmaceutical products. This kit offers high sensitivity and complies with USP, JP, and ICH regulatory standards.

Specification - SHENTEK® Residual E.coli RNA Quantitation Kit (2G)

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