As a leading analytical technology company, CD Formulation has the expertise and advanced measurement platforms to provide our clients with high-quality in vivo drug distribution data. Our team of experts utilizes the latest analytical methods, such as mass spectrometry, radiolabeling, and bioanalysis, to explore the spatial and temporal distribution of drugs in the body.
In vivo drug concentration, especially plasma (or serum), is directly related to drug efficacy and is affected by many factors. In vivo nucleic acid drug distribution measurement is an essential part of the biological drug development process. Its purpose is to evaluate the distribution of nucleic acid drugs in vivo after drug administration, including concentration changes in different tissues/organs, metabolic kinetics, and other parameters. This information helps drug developers to understand the in vivo kinetic profile of the drug candidate, which supports the subsequent pharmacokinetic and pharmacodynamic studies.
Fig.1 In vivo nucleic acid drug distribution measurement. (CD Formulation)
CD Formulation provides a comprehensive and powerful platform for characterizing the bioactivity of nucleic acid drugs, designed to provide you with a solution to describe your drug formulations and facilitate successful product submissions.
We can provide you with a comprehensive determination of the distribution of nucleic acid drugs in major tissues and organs. By establishing the concentration distribution data curve of nucleic acid drugs in each major organ, we can analyze the distribution characteristics and differences of drugs in different target organs, providing you with comprehensive data support for the distribution of nucleic acid drugs in the body organs.
We will use fluorescent or radiolabeled nucleic acids for cell/tissue imaging in vivo or in vitro to observe the enrichment of drugs in target cells/tissues. Through qualitative analysis of the distribution characteristics of the drug at the target site, we can provide a basis for further optimization of the route of administration and dosage form.
We can comprehensively monitor the dynamic distribution of nucleic acids in vivo and establish a detailed pharmacokinetic model. By modeling and analyzing the experimental data, we can establish a detailed pharmacokinetic model of nucleic acid drugs in vivo and clearly describe the dynamic changes of the drugs in vivo. This not only helps to understand the in vivo fate of nucleic acid drugs but also provides an important basis for the design of clinical trials.
Technology Platforms | Descriptions |
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HPLC Technology Platform | The HPLC method is fast, efficient, and easy to operate, and can accurately determine the target substances in the sample. |
LC-MS/MS Technology Platform | The LC-MS system embodies the complementary advantages of chromatography and mass spectrometry. It combines the high separation performance of HPLC with the high-resolution performance of MS, resulting in higher specificity and sensitivity, and allows for the simultaneous detection of a wide range of drugs. |
Immunological Assay (IA) Technology Platform | IA is a detection method based on antigen-antibody specific binding reaction, utilizing the principle of competitive antibody binding between the drug under test and the labeled drug, and then quantitatively analyzing the drug by radiometric counting and colorimetric methods, which has the characteristics of high sensitivity, high specificity, and low sample dosage. |
Biosensing Technology Platform | Biosensing technology is characterized by low cost, low power consumption, fast measurement speed, and easy to carry. |
Capillary Electrophoresis (CE) Technology Platform | CE is an analytical technique that uses capillary as the separation channel and high-voltage electric field as the driving force and realizes the separation by taking advantage of the difference of electric current flow or distribution behavior between different components of the sample. |
Technology: LC-MS technology for in vivo drug loading analysis
Journal: Analytical chemistry
IF: 6.7
Published: 2014
Results:
Analysis of samples containing intact drugs using mass spectrometry provides a direct measurement of drug load distribution. Once a drug is administered, the drug load distribution changes due to a combination of biological and chemical factors. For ADCs containing native disulfide bonds (lysine-linked or cysteine-linked), liquid chromatography-mass spectrometry (LC-MS) methods have been established to measure in vivo drug load distribution. However, analysis of intact cysteine-linked ADCs using LC-MS requires native conditions due to the presence of an IgG reduction step in the conjugation process, thus limiting sensitivity. Although this limitation has been overcome at the analytical scale, to date these methods have not been translated to the smaller scales required for animal or clinical dosing/sampling.
Fig. 2 Deconvoluted mass spectra of drugs from an in vivo study. (Hengel S M, et al., 2014)
CD Formulation has always been committed to providing customers with a full range of bioactivity analysis services platform, customer demand-oriented, to establish the appropriate experimental system and to carry out the completion of the corresponding experimental work. At the same time, we develop in vivo drug distribution measurement strategies according to the characteristics of different projects, including data interpretation and application, etc., to meet the experimental requirements of in vivo drug evaluation of our clients to the best of our ability. Contact us, we will be responsible for your project.
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