CD Formulation offers a full range of analytical testing services from nucleic acid drugs formulation development to scale-up. By working with our biopharmaceutical services team, we are able to customize the analytical methods and solutions for your nucleic acid drugs to meet your needs, thus helping you accelerate the formulation development process.
The analysis and characterization of nucleic acid drugs requires highly sophisticated analytical workflows with a strong focus on regulatory compliance. Nucleic acid drug molecules are susceptible to the formation of various impurities and degradation products that can seriously affect their safety, efficacy and quality. Through different characterization methods, we can accurately confirm the structural features and purity of nucleic acids, detect their chemical modifications, analyze their interactions with other molecules, and accurately quantify nucleic acid samples to provide reliable basic data for subsequent experimental studies and applications.
Fig.1 Nucleic acid drug analysis equipment. (CD Formulation)
CD Formulation offers a comprehensive range of analytical services to support the development and manufacture of nucleic acid drugs. Our state-of-the-art laboratories are equipped with the latest instrumentation and technology to provide various characterization services.
Items | Descriptions |
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Identification for Nucleic Acid Drugs | By combining LC-MS and CE-MS techniques, we can perform detailed characterization of nucleic acid drug samples, identifying and quantifying nucleic acids to ensure the highest quality and safety of products. |
Structural Characterization for Nucleic Acid Drugs | Our senior scientists use advanced techniques such as NMR spectroscopy and MS to thoroughly elucidate the chemical structures and compositions of nucleic acid drugs, including determining base sequences, modifications, and the possible presence of impurities and degradation products. |
Physicochemical Characterization for Nucleic Acid Drugs | Our team focuses on evaluating the physicochemical properties of nucleic acid drugs, such as molecular weight, thermal stability, and higher structure. This comprehensive characterization is essential to understanding the behavior and properties of these complex molecules under different conditions. |
Impurity Analysis for Nucleic Acid Drugs | In addition to characterizing the nucleic acid drugs themselves, we can quantify trace metal impurities and residual solvents using advanced techniques such as ICP-MS to ensure product safety. |
Stability Analysis for Nucleic Acid Drugs | We can conduct forced degradation tests, real-time stability studies, and accelerated stability analysis to comprehensively evaluate the chemical and physical stability of nucleic acid drugs under different conditions to support product safety and expiration dates. |
Safety Analysis for Nucleic Acid Drugs | Safety analysis for nucleic acid drugs involves comprehensive testing and control of particulate matter, sterility, bioburden, and bacterial endotoxins to ensure product quality and biosafety. |
Fig.2 Flow chart of nucleic acid drugs analysis and characterization. (CD Formulation)
CD Formulation has established a one-stop nucleic acid drug analysis and testing service platform oriented to customers' needs, which can provide comprehensive and perfect testing services for the intermediate control of products and the release of final products. Contact us, our professional team will be happy to serve you.