Introduction to Nucleic Acid Analysis
The rapid advancement of gene therapy and nucleic acid-based drugs (such as siRNA, mRNA, ASO, and viral vectors) necessitates rigorous Quality Control (QC) and characterization. Nucleic Acid Analysis is the cornerstone of drug safety and efficacy, encompassing a suite of analytical methods to verify the molecular attributes of the product.
At Creative Biolabs, we offer a "One-Stop" analytical platform. From early discovery to preclinical development and CMC (Chemistry, Manufacturing, and Control) stages, our experts utilize state-of-the-art technologies to assess the critical quality attributes (CQAs) of your nucleic acid products, ensuring they meet the stringent requirements of regulatory authorities.
Our Analytical Capabilities
We provide a modular and fully customizable suite of services covering the five essential pillars of nucleic acid characterization:
Applications of Nucleic Acid Analysis
Genetic Disease Screening
Critical analysis of vector genome integrity, titer determination, and empty/full capsid ratio analysis using AUC and TEM to ensure optimal transduction efficiency.
mRNA Vaccines & Therapeutics
Comprehensive characterization including Capping Efficiency, Poly(A) tail length distribution, and dsRNA impurity detection for maximizing translational efficacy and safety.
Gene Therapy Development
Characterization of viral vectors and transgene integration efficiency to ensure the safety and efficacy of gene therapies for genetic disorders, cancer, and neurodegenerative diseases.
Genome Editing Tools
Validation of gRNA sequences, assessment of Cas9/gRNA complex formation, and highly sensitive off-target analysis using NGS platforms.
Our Technology
High-Res Mass Spec
Orbitrap & Q-TOF systems for exact mass determination and sequence mapping.
AUC & SEC-MALS
Gold standards for analyzing aggregation and empty/full capsid ratios in viral vectors.
Digital PCR (dPCR)
Absolute quantification of nucleic acid copies without the need for standard curves.
NGS Platforms
Deep sequencing for verifying gene edits, plasmid identity, and detecting trace variants.
Key Analytical Technologies
Our platform integrates high-resolution instruments and validated methods to provide deep insights into your nucleic acid products.
| Category | Techniques / Instruments | Application |
|---|---|---|
| Chromatography | IP-RP HPLC, AEX-HPLC, SEC-MALS | Purity, Aggregation, Molecular Weight |
| Mass Spectrometry | LC-MS/MS, MALDI-TOF | Molecular Mass Confirmation, Sequence Verification |
| Electrophoresis | Capillary Gel Electrophoresis (CGE), Bioanalyzer | Integrity, Fragment Analysis |
| Genomics & Molecular Biology | NGS, qPCR, ddPCR | Sequence Identity, Residual DNA, Titer |
| Cellular Assays | Flow Cytometry, ELISA, Luciferase Reporter | Potency, Functional Activity |
Why Choose Creative Biolabs?
Regulatory Compliance
All analytical methods can be developed and validated according to ICH Q2(R1) guidelines, ensuring your data is robust enough for IND and NDA filings.
Comprehensive Expertise
We handle a wide range of nucleic acid modalities, including plasmids, mRNA, siRNA, miRNA, ASOs, and aptamers, with specific protocols optimized for each.
Fast Turnaround
Our streamlined workflows and dedicated project managers ensure rapid data delivery without compromising quality, helping you meet tight development timelines.
State-of-the-Art Technology
Access to cutting-edge instruments like SEC-MALS, AUC, and Digital PCR ensures high-resolution characterization and reliable data for your specific needs.
Cost-Effective Solutions
Optimized protocols and efficient workflows allow us to provide high-quality data and professional reports at competitive pricing.
Dedicated Project Management
A dedicated team of scientists and project managers will guide you through every step, offering 24/7 technical support and seamless communication.
Results Delivery
Upon completion of the analysis, Creative Biolabs provides a detailed Certificate of Analysis (CoA) and a comprehensive study report, including:
Methods
Description of analytical methods and conditions utilized during the study.
Raw Data
Original data including Chromatograms, Spectra, and Electropherograms.
Calculations
Final metrics such as Concentration, Purity %, and Titer values.
Verification
Comparison against pre-defined specifications or industry reference standards.
Customer Reviews
Dr. H. Lee
Senior Researcher, Biotech Co.
"We utilized Creative Biolabs for the full characterization of our mRNA vaccine candidate. Their purity analysis using LC-MS and CGE was incredibly detailed, allowing us to identify minor impurities we missed internally. Their report was pivotal for our process optimization."
Prof. M. Johnson
University Gene Therapy Center
"The potency assays developed by the team were robust and reproducible. They helped us establish a reliable correlation between the in vitro cell-based assay and our in vivo efficacy data. Highly recommended for nucleic acid functional testing."
Frequently Asked Questions
We have experience analyzing a wide variety of nucleic acid types, including plasmid DNA (pDNA), mRNA, siRNA, miRNA, oligonucleotides (ASO), aptamers, and viral vector genomes (AAV, Lentivirus, Adenovirus).
Sample requirements vary depending on the specific assays chosen (e.g., LC-MS requires higher purity than qPCR). Generally, we recommend providing 10-50 µg of purified nucleic acid. Please contact our technical team for specific requirements based on your project needs.
Yes. We offer different levels of validation. For early research, we perform feasibility studies. For late-stage development, we can perform full method validation (Accuracy, Precision, Specificity, LOD/LOQ, Linearity, Robustness) compliant with ICH guidelines.
Absolutely. Since the mechanism of action varies for each gene therapy product, we specialize in developing custom cell-based or biochemical potency assays that reflect the biological activity of your specific nucleic acid.
Ready to characterize your Nucleic Acid Product?
Creative Biolabs offers industry-leading analytical testing services with rapid turnaround times and regulatory expertise. Contact us today to discuss your testing needs and receive a customized proposal.
Our technical support team is available 24/7 to assist you.
Tell us about your project, and our experts will get back to you with a customized quote and proposal.
