mRNA-related Assay Services are essential for detecting, quantifying, and functionally analyzing mRNA in complex biological systems. Leveraging advanced sensor technologies and single-cell analysis, they validate therapeutic mechanisms and ensure product stability, supporting nucleic acid drug development. Creative Biolabs' custom services offer ultra-sensitive detection, high-throughput single-cell analysis, and proprietary stability evaluation. They de-risk therapeutic programs, address analytical bottlenecks, and deliver data meeting regulatory standards for seamless transition to clinical trials.
Our comprehensive portfolio provides the critical analytical solutions required at every stage of your program.
| Assay | Application | Technique |
|---|---|---|
| Nuclease Protection Assay | Precisely maps and quantifies specific RNA transcripts in complex total cellular RNA mixtures, with high specificity and sensitivity for RNA target detection. | Hybridizes a labeled probe to target RNA, followed by nuclease digestion of single-stranded RNA. Only the protected probe-target duplex remains for quantifying target mRNA abundance. |
| PrimeFlow RNA Assay | Gold standard for simultaneous single-cell analysis of RNA transcripts and corresponding proteins via flow cytometry. Ideal for assessing mRNA delivery and translation efficiency in immune cells (e.g., vaccine or T-cell therapy projects). | Uses proprietary oligonucleotide probes and highly efficient branched DNA (bDNA) signal amplification for exceptional detection sensitivity, with no PCR amplification required, preserving cellular morphology. |
| RNA Fluorescence Assay | Quick, precise, and highly sensitive method for quantifying RNA concentration in solution. Often used for high-throughput QC of purified mRNA transcripts before LNP formulation. | Employs specific fluorescent dyes that bind to nucleic acids, producing a signal proportional to RNA concentration. Offers a broad linear response range and superior sensitivity compared to traditional absorbance methods. |
| RNA Methylation Assay | Essential for understanding the impact of key post-transcriptional modifications (e.g., N6-methyladenosine, m6A) on mRNA function, stability, and translation ability. | Provides a series of assays (including absorbance- and fluorescence-based quantitation) to map and measure specific methylation mark levels, supporting construct optimization for stability and translation. |
Our comprehensive workflow is designed for clarity, repeatability, and speed, providing detailed, actionable results at every stage.
Conduct deep-dive meeting to define client needs, select/custom-design mRNA assay (e.g., fluorescence polarization, electrochemical, PrimeFlow), and establish QC metrics/controls.
Prepare the client’s mRNA sample, challenge with biological matrices (serum, cellular lysates) or stress factors (temperature, nucleases) to simulate in vivo conditions.
Perform selected assay using state-of-the-art platforms, ensuring minimal sample loss and high data precision.
Process raw data via validated software (background subtraction, standard curve generation, detection limit calculation, statistical analysis).
Prepare a comprehensive report summarizing methods, results, conclusions, and strategic recommendations.
Typical 3–8 weeks, varying by mRNA construct complexity, number of samples, and need for de novo assay development or full validation.
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As a leading partner in nucleic acid therapeutics, Creative Biolabs provides customized analytical solutions that are crucial for advancing your mRNA pipeline. We ensure your data is robust, regulatory-compliant, and directly addresses the unique challenges of your therapeutic modality.
Customized Assay Development:
Custom-design RNA and LNP assay protocols to match the unique properties (length, modifications, delivery vector) and stability profile of your specific mRNA construct.
Ultra-Sensitive Contaminant Detection:
Use advanced fluorescence polarization and Electrochemical Sensor technologies to detect nucleases (RNase, DNase) with limits far lower than standard methods.
Functional mRNA Proof-of-Concept:
Leverage PrimeFlow RNA Assay to deliver single-cell co-expression data, validating cellular uptake and successful protein translation in vitro and ex vivo.
Modular Assay Integration:
Seamlessly integrate with Creative Biolabs' Custom mRNA Synthesis and LNP Engineering services for a cohesive one-stop solution from design to analytical validation.
Regulatory-Focused Documentation:
Document all assay processes with a Quality-by-Design (QbD) approach, ensuring data integrity and suitability for IND submission.
Targeted Stability Evaluation:
Implement sophisticated assays (e.g., RNA Methylation Assay, stability kinetics) to quantify how modifications (m6A, Pseudouridine) impact mRNA half-life.
High-Throughput Capability:
Optimize assay platforms for high-throughput screening and large-scale sample analysis, accelerating selection of stable, efficacious LNP formulations.
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A: qPCR measures transcript quantity, while our advanced assays (e.g., PrimeFlow RNA Assay) provide single-cell transcript-protein co-expression data, offering superior proof of delivery and function that qPCR cannot.
A: We customize services like the PrimeFlow RNA Assay to quantitatively track mRNA signals in target cells and correlate with protein production, providing direct evidence of successful endosomal escape and functionality.
A: Yes. We use Nuclease Protection Assay and proprietary RNA degradation assays to test mRNA stability in biological matrices, delivering real-world profiles for shelf-life and handling specifications.
A: Absolutely. Our ultra-sensitive fluorescent/electrochemical sensors (e.g., RNA Fluorescence Assay) detect trace RNase contamination at ppb levels, exceeding basic QC methods to ensure product safety.
A: Yes. RNA Fluorescence Assays and certain PrimeFlow applications are optimized for high-throughput multi-sample processing, delivering rapid, reliable data without compromising precision.
Creative Biolabs offers an end-to-end suite of mRNA Related Assay Services, delivering the quantitative data necessary for stability testing, mechanism of action validation, and regulatory approval. We turn analytical complexity into actionable results for your therapeutic program.
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