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Analytical Technology Platforms

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For the quality control of nucleic acid drugs, it is essential to assess not only the necessary structural and physicochemical properties but also the biological binding activity, functional activity, and other biological activities. CD Formulation has a world-class analytical platform, which provides a full range of analytical services for nucleic acid drugs, including primary and advanced structural characterization, biological activity characterization, purity analysis, process-related impurities and residue testing, and so on.

Our Capabilities of Analytical Technology Platforms for Nucleic Acid Drugs

Particle Analysis of Formulations
Molecular Validation of Nucleic Acids
Impurity Analysis
Stability Studies
Safety Testing
Method Development, Transfer, and Validation
PK/TK - Pharmacokinetics Analysis
Immunogenicity Assays
Functional In Vitro Assays
Toxicity Analysis
Biomarker Analysis for Drug Development
Process Development

Advantages of Our Analytical Technology Platforms

Fig.1 Advantages of our analytical technology platforms. (CD Formulation)

Types of Our Analytical Technology Platforms

CD Formulation's analytical platforms offer GLP-compliant analysis of biological samples in accordance with relevant technical guidelines. The platform utilizes state-of-the-art analytical equipment, including MS, HPLC, MSD, qPCR, and ddPCR... It establishes both an advanced physical characterization platform and a bioanalytical platform, enabling structural identification of nucleic acid formulations, assessment of stability and impurities, pharmacodynamics (PD), pharmacokinetics (PK), immunogenicity, biomarkers, and other related studies.

Physical and Chemical Characterization Platforms

Items	Descriptions
HPLC Platform	For the separation and quantitative analysis of nucleic acids and their associated components.
GC Platform	For the analysis of volatile substances.
IR Platform	For the analysis of molecular structures and functional groups.
UV-Vis Platform	For the determination of nucleic acid concentration and purity.
NMR Platform	A detailed analysis of molecular structure.
MS Platform	For the analysis of molecular weight and structure.
DLS Platform	For the analysis of particle size distribution and aggregation states.
CD Platform	For the analysis of the secondary structure of nucleic acids.
DSC Platform	For the thermal characterization and analysis of phase transitions.
TGA Platform	For evaluating the thermal stability of materials.
SEM Platform	To visualize the surface morphology of the samples.
Zeta Potential Analysis Platform	The study evaluates the surface charge and stability of particles.

Bioanalytical Platforms

Items	Descriptions
Droplet Digital PCR (ddPCR) Technology Platform	For highly sensitive quantitative analysis of nucleic acids.
Polymerase Chain Reaction (PCR) Technology Platform	For the amplification and analysis of nucleic acids.
Real-Time Quantitative Polymerase Chain Reaction (qPCR) Technology Platform	For real-time monitoring of nucleic acid amplification processes.
ELISA Technology Platform	The method detects the presence of specific proteins or antibodies.
MSD Technology Platform	For the detection of multiple biomarkers.
Surface Plasmon Resonance (SPR) Platform	For the real-time monitoring of molecular interactions.

Highlights of Our Analytical Technology Platform for Nucleic Acid Drugs

Complementary central laboratory services offer comprehensive, one-stop testing solutions for the entire process.
Always striving to meet customer needs through a spirit of win-win cooperation.
Always prioritize delivery timeframes while ensuring quality.
A more flexible project management process that adapts to the unique characteristics and needs of various projects.

Our Analytical Characterization Services

CD Formulation offers a range of analytical technology platforms for the quality control of nucleic acid drugs, featuring the following capabilities:

Nucleic Acid Drug Toxicology Analysis

Evaluate the toxicity of nucleic acid drugs on normal and tumor cells to ensure their safety.

Nucleic Acid Drug Immunogenicity Testing

Evaluate the immune responses that nucleic acid drugs may elicit using precise bioanalytical techniques.

Pharmacodynamic Evaluation

Evaluate the efficacy of nucleic acid drugs through both in vitro and in vivo experiments, including the impact of modulating target gene expression.

Stability Analysis for Nucleic Acid Drugs

To investigate the chemical and physical stability of nucleic acid drugs under various conditions, ensuring their effectiveness throughout the drug life cycle.

Impurity Analysis for Nucleic Acid Drugs

This process detects impurities in nucleic acid drugs, including degradation products, residual solvents, and other contaminants, to ensure the purity of the drug.

Physicochemical Characterization

Evaluate the physical properties of nucleic acid drugs, including particle size, morphology, and solubility, to optimize drug formulation and delivery.

Nucleic Acid Drug Biomarker Testing

Biomarker assays support various applications in drug development, including pharmacological studies and clinical trials.

Publication Data

Technology: PCR analysis for nucleic acid detection

Journal: Frontiers in Microbiology

IF: 4.0

Published: 2022

Results:

Nucleic acid testing has become the primary method for detecting SARS-CoV-2 due to its high sensitivity and specificity. An in-depth understanding of the different diagnostic methods for COVID-19 will help researchers to make the best choice when detecting COVID-19 at different symptomatic stages. In the review, the authors summarize and evaluate recent advances in current SARS-CoV-2 nucleic acid detection methods. In particular, the authors discuss biosensors and CRISPR-based diagnostic systems and their features and challenges. In addition, the authors systematically present and discuss the emerging COVID-19 variants and their impact on SARS-CoV-2 diagnosis.

Fig.2 PCR analysis for nucleic acid detection Fig.2 Workflow of SARS-CoV-2 nucleic acid detection. (Zhu Y, et al., 2022)

CD Formulation boasts a state-of-the-art laboratory equipped with top-tier experimental tools, offering comprehensive biological testing services in molecular biology, immunology, cell biology, pathology, and biosafety. Our skilled technical team possesses extensive experience in experimental operations, method development, and data analysis, enabling us to deliver a complete suite of technical services for nucleic acid preparations. Contact us today, and we will tailor a professional nucleic acid analysis solution to meet your specific needs.

References

Zhu Y, Zhang M, Jie Z, et al. Nucleic acid testing of SARS-CoV-2: A review of current methods, challenges, and prospects. FRONT MICROBIOL. 2022, 13: 1074289.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

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STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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