Micro-sampling Technology in Drug Analysis

When conducting biotechnology drug research and development, conducting biopharmaceutical analysis is an important part of ensuring drug quality, and it is also a routine work content. Generally speaking, the working procedures of drug inspection include sampling, shape inspection, identification test, purity inspection, content determination, etc. The quality inspection procedures of biotechnology drugs are basically the same as those of chemically synthesized drugs. Today we will learn about micro-sampling technology.

In principle, biological samples include various biological fluids and tissues, but in practice, the most commonly used blood includes plasma, serum or whole blood, urine and saliva, etc. These samples are relatively easy to obtain. The detection of drugs and their metabolites in biological samples is called biopharmaceutical analysis. When conducting bioanalytical services, in order to provide sufficient samples for biological quantitative analysis, such as plasma samples, a large amount of whole blood is often consumed. However, only a series of samples can be collected from a single experimental animal, so it is often necessary to use mixed samples instead. The use of mixed samples may lead to a decrease in the reliability of the pk study data and an increase in the demand for animals.

Most of the samples in vivo have the characteristics of small sampling amount, low concentration of analytes, and many interfering substances. Therefore, the characteristics of biopharmaceutical analysis are that the samples in vivo need to be separated and concentrated, or can be analyzed after chemical derivatization. The method requires high sensitivity and specificity, the analysis workload is large, the measurement data processing and the interpretation of the results are more complicated. Medicilon Bioanalysis Service Department has a professional scientific research team, the analysis laboratory is equipped with advanced instruments and equipment, and implements comprehensive information management. The experimental research meets the requirements of FDA/CFDA GLP standards. The service content involves pharmacokinetics and pharmacodynamics. , Immunogenicity and bioequivalence, etc., to provide customers with the screening and development of small molecule drugs, biological agents, vaccines and biomarkers, as well as preclinical and clinical research.

In biological analysis, apart from the need to freeze and properly handle the transportation and storage of plasma samples, the plasma used for biopharmaceutical analysis must be separated and prepared from whole blood, and through solid phase separation, liquid-liquid separation Or the separation step of the protein precipitation method is very time-consuming, which limits the detection throughput and the final sample detection quantity. With the development of science and technology, the rise of new high-sensitivity and high-resolution mass spectrometry has made the actual sample size required in biological and medical analysis smaller, providing a broad space for the development of micro-sampling technology.

The dried blood spot (DBS) sampling method is a new alternative technology for collecting biological samples. The DNS method has a small blood volume, so it is particularly suitable for continuous sample sampling of small animals. With the continuous improvement of the analytical sensitivity and reproducibility of LC-MS/MS, the use of LC-MS/MS for the quantitative analysis of DNS samples provides reliable preclinical pharmacokinetic studies in biopharmaceutical analysis Technical Support.

For example, microdialysis, a micro-biochemical sampling and detection technology developed in the 1980s, is a new type of biochemical sampling technology developed in modern medicine. It can conduct biochemical sampling of the extracellular fluid of living tissues and is almost suitable for the analysis of small molecule active substances used. And the damage to the tissue is minimal. Because this technology has the advantages of living body sampling, dynamic observation, quantitative analysis, small tissue damage, less sampling, convenient, fast, continuous monitoring, and easy automation, it has been widely used in various basic medical research fields abroad. The fields of medicine, pharmacy, and life sciences provide a space for the development of new technologies.

Compared with traditional plasma sampling methods, the use of micro-sampling technology has the advantages of less blood collection, which is particularly suitable for blood sample collection of small animals, and is convenient for blood sample collection, storage and transportation. Therefore, it has broad application prospects in biopharmaceutical analysis.