- Polypeptide is a kind of compound which is composed of less than 100 amino acids connected by peptide bond, and usually has secondary structure.
- Amino acid sequence diagram and product map of liraglutide
- Triple quadrupole liquid chromatography mass spectrometry
- Shimadzu shimsen low adsorption PP sample bottle / plate
- Shimadzu alsachim stable isotope internal standard
However, compared with other small molecule drugs, peptide has the characteristics of adsorption and high molecular weight, so it brings more challenges in sample storage, pretreatment, selection of chromatographic column and development of instrument and method.
Polypeptide is a kind of compound which is composed of less than 100 amino acids connected by peptide bond, and usually has secondary structure.
Since the advent of insulin therapy in 1920s, peptide drugs have been playing an important role in the field of medicine. Compared with small molecule drugs, peptide drugs have higher biological activity and specificity, and better stability than protein drugs.
With the continuous development of biotechnology, more and more peptide drugs have been developed and applied in clinic. Due to wide indications, high safety and significant curative effect, peptide drugs are widely used in tumor, diabetes, AIDS, bacterial and fungal infection, immunity, cardiovascular, urinary and other aspects.
Amino acid sequence diagram and product map of liraglutide
As early as 2017, an article [1] in the “impact story” column released by FDA mentioned that there are nearly 100 kinds of peptide drugs on the market in the world, and the global sales volume is about 15-20 billion US dollars. The research and development of new peptide drugs and peptide generic drugs are facing great opportunities and challenges.
The application for new indications of peptide drugs received by FDA is increasing rapidly. Meanwhile, the emergence of generic drugs is accelerating the development of peptide drugs.
However, in order to ensure the stability and quality of drug development and characterization of generic drugs, it is particularly important to ensure the stability of drug research and characterization. Experts from the FDA’s Center for drug evaluation and Research (CDER) believe that mass spectrometry (MS) is a key technology for the analysis of peptide drugs.
Combined with liquid chromatography and mass spectrometry, LCMS has been widely used in the development of analytical methods for peptide drugs, especially those containing biological matrix, because of its good specificity, high sensitivity, wider dynamic range, and higher accuracy and precision. Similarly, LCMS method is also suitable for the clinical use of peptide drugs monitoring.
Shimadzu released lcms-8060nx on July 16
Triple quadrupole liquid chromatography mass spectrometry
However, compared with other small molecule drugs, peptide has the characteristics of adsorption and high molecular weight, so it brings more challenges in sample storage, pretreatment, selection of chromatographic column and development of instrument and method. In particular, peptides are easy to adsorb on the solid surface, which may eventually lead to the deviation of concentration measurement. Therefore, low adsorption material products are usually recommended to preserve peptide drugs.
Shimadzu shimsen low adsorption PP sample bottle / plate
Shimsen low adsorption PP material series of sample bottles and sample plates, the use of patented technology for special treatment of PP materials, so as to achieve the effect of greatly reducing the adsorption amount, so as to ensure higher accuracy of data in the analysis and detection, and effectively avoid the problems of poor linearity, low response and concentration change caused by adsorption and other reasons.
In the development of bioanalysis methods for polypeptide drugs, there is also a very important problem in the selection of internal standard (is). Internal standard plays an important role in ensuring the accuracy and robustness of LCMS method.
The selection of stable isotope internal standard for LCMS bioanalysis method has gradually become the “gold standard”. Considering the complexity of peptide drug bioanalysis method, the internal standard containing 13C and more labeled is preferred when selecting stable isotope internal standard!
In addition to providing instruments and consumables, Shimadzu has also developed high-quality stable isotope internal standard products in the field of pharmaceutical bioanalysis.
Shimadzu alsachim stable isotope internal standard
In addition to the above products, Shimadzu also provides customized synthetic stable isotope internal standard products for peptide drugs. All internal standards were provided with detailed detection data of HPLC, LCMS and NMR.
[1] References: https://www.fda.gov/drugs/regulatory-science-action/impact-story-developing-tools-evaluate-complex-drug-products-peptides
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Source: Instrument Information Network
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