Residual RNA Testing

As cell and gene therapies continue to evolve, the need to utilize bacterial or eukaryotic cell lines for the production of biologics is on the rise. Detection of residual impurities during the production process and in the final product has become a critical step in assessing the quality, safety and stability of these biologics. Residual RNA is currently a major impurity in the development of biologics and therapeutics, and can be present at different stages of production, including host cell RNA, RNA transcripts associated with the production process, and viral RNA impurities. Residual RNA not only affects the biological activity of these biologics, but also poses potential safety risks (e.g., immune responses triggered by activation of cell membrane interferon pathways by exogenous RNA). Therefore, accurate detection and quantification of RNA residues is required to support process validation, monitor lot-to-lot variation, and ensure the quality and safety of the final product. Creative Biogene's highly knowledgeable analytical specialists help clients quantify residual RNA in their products using validated assays. Our highly sensitive analytical tools and assay kits accurately quantify residual RNA in samples and detect even trace amounts.

Residual RNA Detection Scope

Host cell (HEK293, E. coli and CHO cells, etc.) RNA residue testing
Different types of cell lines are commonly used as expression systems for attractive biologics. Residual RNA in biologics produced using cell lines can negatively impact the purity, quality and safety of the product. Creative Biogene has a GMP-compliant testing platform paired with our RNA residue quantification Kits based on qPCR detection technology to provide a comprehensive assay report that ensures the accuracy and credibility of the results.
RNA transcripts testing associated with the production process
During biopharmaceutical production, RNA is typically used as a starting material or intermediate, such as in the production of mRNA-based vaccines or recombinant proteins. However, to comply with regulatory guidelines, any residual RNA from these processes must be minimized or eliminated to avoid potential adverse effects on patients. Creative Biogene utilizes advanced assay technology in conjunction with our highly sensitive residue RNA quantification kits for reliable detection of residual RNA in biologics manufacturing processes. With detection limits as low as fg/ul and high precision, we can accurately monitor impurities in the manufacturing process to support process development and validation.
Viral RNA impurities testing
Viral contamination can occur at all stages of the biologics manufacturing process. An important aspect of a quality control program is the regular monitoring and removal of potential viral RNA impurities to ensure the safety and efficacy of biologics. Our advanced testing technology can effectively detect a wide range of RNA viral contaminants, including the identification of known and emerging viruses, helping our customers to minimize any potential risks to their manufacturing processes.

Residual RNA Testing Platform at Creative Biogene

Creative Biogene has established a complete residual RNA detection platform based on RT-qPCR detection technology. The platform employs validated detection technologies and quantitative products to help customers rapidly identify and quantify residual RNA in their biological products. Our standardized assay process reduces systematic errors between experimental batches and includes the following aspects:

Total RNA extraction.
RNA reverse transcription into cDNA.
Real-time fluorescence quantitative PCR assay for amplification.
Data analysis.

Features of Our Residual RNA Testing Services

High-throughput sample extraction equipment and advanced detection technology.
Commercialized assay kits are designed with specific primers and probes for stable and reliable results.
One-stop testing service, which can quickly provide accurate test reports.

Creative Biogene specializes in Residual RNA Testing services for a diverse array of host cells, including but not limited to human cells, HEK293, CHO, Vero, NS0, MDCK, E. coli, and Pichia pastoris. Additionally, we offer custom assay development services for unique or specialized host cells. Our expertise ensures precise, reliable results tailored to meet the specific requirements of your unique cell line, enabling advanced research and development in biotechnology and pharmaceutical applications. Partner with Creative Biogene for customized solutions that cater to the nuanced demands of your special host cells.

* For research use only. Not intended for any clinical use.

Quick Inquiry