Safety of Nucleic Acid
Nucleic acids, comprising polymeric sequences of nucleotides such as RNA, DNA, and their analogs, are being increasingly explored as direct therapeutic agents for addressing a broad spectrum of disease conditions. Assessing the safety of nucleic acids is crucial for advancing scientific research, ensuring treatment efficacy, and meeting regulatory requirements. Only through comprehensive safety assessments can the safety and efficacy of nucleic acid therapeutic drugs be ensured. Analyzing the safety of nucleic acids involves multiple aspects. As a professional nucleic acid manufacturer, Creative Biolabs provides some of the main aspects along with corresponding detection methods, as shown in Tab.1.
Tab.1 The safety assessment of nucleic acids.
| Test Item | Methods and Description |
|---|---|
| Human Source Contamination (HSC) |
Detecting whether the sample is contaminated with human genomic DNA templates. This is suitable for nucleic acid products requiring control over exogenous genes and environmental contamination, enabling precise confirmation of the type and degree of exogenous contamination through the synthesis of probes. |
| Endotoxin |
Using the Limulus reagent for semi-quantitative detection of endotoxin helps mitigate its impact on downstream experiments, ensuring accurate results. Endotoxin detection in samples intended for animal experiments and endotoxin-sensitive cell assays, such as those involving stem cells. |
| Sterility | Sterility validation involves evaluating the bacteriostatic and fungistatic properties of nucleic acids to prevent any interference with the detection of microbial contaminants. |
| Bioburden | This assay quantifies the total number of viable microorganisms present in nucleic acid products or on the surfaces of production equipment. |
| Toxicity Assays |
This involves in vitro assessments of cell viability, proliferation, gene expression, and cellular functionality, alongside in vivo evaluations such as immunotoxicity, hepatotoxicity, nephrotoxicity, immunohistological analysis, and other comprehensive toxicity screenings. Techniques like cell viability assays, gene expression analysis, and histopathological examination are used. |
| Immunogenicity Assays |
Assess the immunogenic potential of nucleic acids by measuring immune cell activation, cytokine release, or antibody production in vitro or in vivo. Using lymphocyte proliferation assay in vitro, and white blood cell interleukin determination, lymphocyte expression analysis in vivo. |
SERVICES
The safety testing of nucleic acids involves assessing various aspects to ensure their safe use in biomedical applications. Creative Biolabs is committed to delivering thorough nucleic acid safety services globally. With our advanced technology and skilled scientists, we guarantee top-notch service quality for your nucleic acid. For further details, please don't hesitate to reach out to us for a price quote. We promise a response within 24 hours and will collaborate closely with you to devise an ideal method tailored to your project requirements.
