CD Formulation's team is dedicated to providing quality services for the comprehensive characterization of nucleic acid drugs. We have established technology platforms and solutions for small nucleic acid drugs and mRNA drugs in accordance with the guidelines of national pharmacopoeias and ICH Q6B. Additionally, we adhere to the quality control laboratory management system, ensuring that our research results meet the requirements of global drug registration and filing studies. We work closely with our clients to complete audits and on-site verifications by the drug regulatory authorities.
Nucleic acid drug identification is a specialized analytical service used to confirm the identity of nucleic acid drugs. Complex testing and analysis are required to verify the presence of specific nucleic acid sequences. This ensures that the drug is genuine and free from contaminants or adulterants. Accurate identity testing is essential to prevent misidentification, counterfeiting, and substitution to protect patient health and maintain the integrity of the pharmaceutical supply chain.
As a trusted analytical service provider in the pharmaceutical field, CD Formulation deeply understand the crucial role of high-quality analytical support in the research and development of nucleic acid drugs. We have assembled an experienced team of experts in biology, chemistry, pharmaceuticals, and instrumental analysis and have introduced state-of-the-art analytical testing facilities. Our services cover all stages of nucleic acid drug development and production, including purity analysis and quantification analysis, ensuring comprehensive and professional solutions for our clients.
Our nucleic acid drugs characterization services cover:
Our Services | Identification Method | Principle |
---|---|---|
Concentration Identification | UV Spectrophotometry | This method is based on the fact that the bases in nucleic acid molecules have a conjugated double-bond structure and can absorb ultraviolet light, with a maximum absorption wavelength of 260 nm. |
Fluorescence Photometry | The fluorescent dye ethidium bromide is intercalated between the bases and emits an orange-red fluorescence when exposed to UV light. The fluorescence intensity is directly proportional to the concentration of nucleic acid in the solution. | |
Purity Identification | UV Spectrophotometry | Difference in UV absorption properties between proteins and nucleic acids. |
Fluorescence Photometry | Gel electrophoresis is used to observe patterns and can identify DNA products with or without RNA interference, and vice versa. | |
Integrity Characterization | Gel Electrophoresis | Determination based on the number, position and shape of electrophoretic bands. |
Nucleic Acid Hybridization | - | |
Microarray Assay | - |
In addition to the above analytical methods, we also provide various other analytical techniques to ensure that our clients receive the most professional and comprehensive nucleic acid identification reports.
CD Formulation utilizes a variety of cutting-edge technologies for accurate and reliable identity testing. The testing methods we utilize include, but are not limited to, the following.
Fig.1 Flow chart of nucleic acid drugs identification. (CD Formulation)
Sample Preparation: The first step is to prepare an appropriate concentration of analyte from the synthesized or extracted nucleic acid drug sample.
Structural Analysis: Techniques such as NMR and MS can accurately determine the chemical structure, molecular weight, composition, and other key parameters of the nucleic acid drug.
Purity Testing: HPLC, CE, and other techniques to separate and detect impurities that may be present in the sample.
Content Determination: The use of UV spectrophotometer or fluorescence spectrophotometer, along with other analytical instruments, can quickly and sensitively determine the concentration of nucleic acid drug solutions.
Data Analysis and Reporting: The results of the above analyses are combined to form a comprehensive molecular identification report of the nucleic acid drug. It provides a reliable basis for subsequent drug development, registration, and production.
Technology: Identification of nucleic acids using the FTICR mass spectrometry technology
Journal: Mass Spectrometry Reviews
IF: 9.37
Published: 2005
Results:
In this work, the authors review the fundamental aspects of nucleic acid analysis using Fourier Transform Ion Cyclotron Resonance (FTICR), focusing primarily on the analysis of DNA oligonucleotides, but also describing applications related to the characterization of RNA constructs. The purpose of this review article is to provide the reader with an understanding of the breadth and scope of the current state of the art in FTICR analysis of nucleic acids and to summarize several recently published reports in which researchers have utilized the performance attributes of FTICR to characterize nucleic acids in support of both basic and applied research disciplines, including genotyping, drug discovery, and forensic analysis.
Fig. 2 Specificity of DNA duplex formation in solution monitored using ESI-FTICR-MS. (Hofstadler S A, et al., 2005)
At CD Formulation, we understand the significance of nucleic acid drug characterization in biologics development and manufacturing. If you are interested in our services, please do not hesitate to contact us. We will offer you expert advice and support to facilitate a seamless start and implementation of your project.
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