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Physicochemical Characterization for Nucleic Acid Drugs

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Physicochemical characterization of nucleic acid drugs involves various analytical techniques to assess their physical and chemical properties. CD Formulation offers advanced analytical services and expert scientific support to help clients understand their drug candidates for informed decision-making during development.

About Physicochemical Characterization of Nucleic Acid Drugs

Nucleic acid drugs, including DNA, RNA, and their modified analogs, are a transformative class of biopharmaceuticals that utilize genetic information to treat various diseases. These drugs have complex molecular structures and delicate physicochemical properties, necessitating specialized analytical techniques and expertise to ensure their quality, safety, and efficacy. The physicochemical properties of nucleic acid drugs, such as solubility, partition coefficient, intrinsic dissolution rate, and thermal stability, directly impact crucial drug characteristics like solubility, absorption, and stability. This data is essential for formulation development and quality control.

Fig.1 Physicochemical characterization techniques for siRNA. Fig. 1 siRNA gel retardation assays. (Kapoor M, et al., 2012)

Explore Our Physicochemical Characterization Services for Nucleic Acid Drugs

CD Formulation offers comprehensive biopharmaceutical analytical services for nucleic acid drugs in preclinical studies. Our nucleic acids drugs analytical services department is staffed by dedicated researchers and developers with advanced analytical instrumentation for complete characterization of nucleic acid drugs, offering solutions from target screening to pilot production.

Our experts analyze the physicochemical properties of nucleic acid drugs, including solubility, thermal stability, and pH dependence, using techniques like UV-visible spectroscopy, differential scanning calorimetry, and electrophoresis.

Various physicochemical characterization programs are available for nucleic acid drugs.

Molecular Weight Confirmation for Nucleic Acid Drugs

Particle Size Analysis for Nucleic Acid Drugs

Zeta Potential Analysis for Nucleic Acid Drugs

Morphological Analysis for Nucleic Acid Drugs

Optical Rotation Testing for Nucleic Acid Drugs

pH Testing for Nucleic Acid Drugs

pKa Determination for Nucleic Acid Drugs

Moisture Content Determination for Nucleic Acid Drugs

Molar Extinction Coefficient Determination for Nucleic Acid Drugs

Melting Temperature (Tm) Testing for Nucleic Acid Drugs

Our Expertise and Technologies for Nucleic Acid Drugs Physicochemical Characterization

The insights from physicochemical characterization data are crucial for developing nucleic acid drugs to meet regulatory standards. CD Formulation provides various solutions for nucleic acid drugs formulation development, quality control, and scale-up, such as chromatography, mass spectrometry, spectroscopy, electrophoresis, and related services.

The physicochemical analysis and characterization of nucleic acid drugs necessitates advanced analytical workflows with a focus on regulatory compliance. Key analytical techniques include the following.

Technologies	Items
Chromatography Technology	UPLC, HPLC, Nano HPLC, GC, IC, SEC, SFC
Mass Spectrometry Technology	QTOF, MALDI-TOF, LC-Orbitrap, LC-MS, LC/MS/MS, 2D LC-MS, GC-MS
Solid State Characterization Technology	XRPD, DVS, DSC, TGA with MS interface, PSD, nano-particle size analyzer, polarized light microscope, SEM
Routine Testing Technology	KF, UV-Vis, Polarimeter
Elemental Analysis Technology	ICP-OES, ICP-MS
Other Characterization Technology	NMR, HRMS, FT-IR

Our Workflow of Nucleic Acid Drugs Physicochemical Characterization Services

In addition to providing high-quality and high-value characterization services to our customers, we also handle the entire process of communication of needs to the implementation of results.

Fig. 2 Nucleic acid drug physicochemical identification service process. Fig. 2 Our workflow of nucleic acid drugs physicochemical characterization services. (CD Formulation)

Why Choose Us for Nucleic Acid Drugs Physicochemical Characterization?

Our nucleic acid analysis services offer extensive customer coverage and comprehensive solutions.
7/24 nanny service.
1-to-1 project matching, assisting with program design, sales communication, and after-sales issue resolution.
Our tool can analyze various samples with different quality attributes. Our equipment includes a range of instruments with mass spectrometry at its core, spanning chromatography, spectroscopy, and other platforms.

Publication Data

Technology: Characterization of nucleic acid-containing nanoparticles by TEM & AFM technology

Journal: Bioconjugate chemistry

IF: 4.7

Published: 2007

Results:

Nucleic acid-based therapies have the potential to provide potent and highly specific treatments for a wide range of human diseases. However, systemic delivery remains a major obstacle to success. Here the authors describe the physicochemical and biological properties of cyclodextrin-containing polycations (CDPs) and the nanoparticles they form with nucleic acids, including plasmid DNA (pDNA) and small interfering RNA (siRNA). These particles protect the nucleic acid payload from nuclease degradation, do not aggregate at physiological salt concentrations, and have minimal effect on erythrocyte aggregation and complement fixation at concentrations typical of in vivo applications.The uptake of nucleic acid-containing particles by HeLa cells was measured by flow cytometry and observed by confocal microscopy. Competitive uptake assays showed that transferrin-targeted particles enhanced affinity for the transferrin receptor through an affinity effect (multiligand binding). The functional efficacy of delivered pDNA and siRNA was demonstrated by luciferase reporter protein expression and gene knockdown, respectively. Analysis of CDP delivery vehicles provided insights that can be used to design general targeted nucleic acid delivery vehicles.

Fig. 3 Characterization of unPEGylated and PEGylated siRNA particles by TEM & AFM. Fig. 3 TEM and AFM images of unPEGylated and PEGylated siRNA particles. (Bartlett D W, et al., 2007)

CD Formulation’s expert team offers customized physicochemical property testing solutions tailored to your nucleic acid drug's characteristics and development stage. These analyses provide essential data to support drug development, enhance formulations, and predict in vivo performance. Contact us for more information or to discuss your specific requirements. We are committed to delivering professional and efficient technical support.

References

Kapoor M, Burgess D J, Patil S D. Physicochemical characterization techniques for lipid based delivery systems for siRNA. Int. J. Pharm. 2012, 427(1): 35-57.
Bartlett D W, Davis M E. Physicochemical and biological characterization of targeted, nucleic acid-containing nanoparticles. Bioconjugate Chem. 2007, 18(2): 456-468.

How It Works

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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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