在生物相似性评估的背景下,结构质谱法最近的进展:从序列异质性到更高阶结构
Jérôme Castel1, Sarah Delaux1, Oscar Hernandez-Alba1
1Laboratoire de Spectrométrie de Masse Bio-Organique, IPHC UMR 7178, Université de Strasbourg, CNRS, Strasbourg 67087, France; Infrastructure Nationale de Protéomique ProFI, FR2048 CNRS CEA, Strasbourg 67087, France.
Journal of pharmaceutical and biomedical analysis
|September 15, 2023
概括
质谱法对于表征生物治疗药物及其生物类似版本至关重要. 这些技术提供了监管部门批准和确保产品质量所必需的详细结构信息.
科学领域:
- 生物制药学分析分析
- 分析化学是一种分析化学.
- 结构生物学是结构生物学.
背景情况:
- 生物治疗药物和生物类药物在制药市场上越来越重要.
- 监管机构要求进行彻底的表征,以确保分析生物相似性.
- 评估关键质量属性对于生物制药开发至关重要.
研究的目的:
- 审查结构质谱学的最新进展.
- 突出这些方法在生物治疗和生物相似性表征中的应用.
- 强调质谱在实现分析生物相似性的作用.
主要方法:
- 原生质谱学 (原生成员国)
- -交换质谱法 (HDX-MS) 是一种质谱法.
- 上向下的质谱学 (上向下的MS)
主要成果:
- 结构质谱法提供从初级序列到更高阶结构的综合数据.
- 这些技术对于对复杂生物制药的深入表征至关重要.
- 最近的发展已经扩大了MS的生物治疗分析能力.
结论:
- 结构质谱学对于生物治疗和生物类似物表征是不可或缺的.
- 这些分析策略是满足生物相似性监管要求的关键.
- 在MS技术的持续创新将进一步提高生物制药质量评估.
相关概念视频
Mass Spectrometry: Complex Analysis
820
Mass spectrometry is an important technique for the identification of pure compounds. However, it has some limitations for the analysis of complex mixtures, often due to excessive fragmentation making the spectrum too complicated to decipher. Mass spectrometry can be combined with suitable separation methods in sequence, forming hyphenated methods, which are useful in the analysis of complex mixtures.
GC–MS is a powerful hyphenated method commonly used in forensics and environmental...
GC–MS is a powerful hyphenated method commonly used in forensics and environmental...
820
Peptide Identification Using Tandem Mass Spectrometry
6.5K
Tandem mass spectrometry, also known as MS/MS or MS2, is an analytical technique that employs two mass analyzers. Essentially it is a series of mass spectrometers that helps isolate a particular biomolecule and then helps study its chemical properties.
This technique helps gather information regarding the protein from which the peptide was obtained and to study the peptides’ amino acid sequence. Identifying peptides from a complex mixture is an important component of the growing field of...
This technique helps gather information regarding the protein from which the peptide was obtained and to study the peptides’ amino acid sequence. Identifying peptides from a complex mixture is an important component of the growing field of...
6.5K
High-Resolution Mass Spectrometry (HRMS)
1.4K
The resolution of a mass spectrometer depends on the efficiency of separating ions with different ion masses. The mass of an atom is approximated to the sum of the masses of protons and neutrons inside, considering the masses of protons and neutrons as equal. However, the masses of the proton (1.6726 × 10−24 g) and neutron (1.6749 × 10−24 g) are not truly equal. There is a minor error in the expression of atomic masses relative to the simplest atom of hydrogen. For...
1.4K
Mass Spectrometry: Overview
5.3K
Mass spectrometry is an analytical technique used to determine the molecular mass and molecular formula of a compound. The basic principle of mass spectrometry is to generate ions from the analyte molecule and measure these ion abundances against their molecular mass. One common type of ionization, known as electrospray ionization or EI, bombards the analyte molecules in the gas phase with high-energy electron beams. The electron beams displace an electron from the molecule and leave...
5.3K
MALDI-TOF Mass Spectrometry
4.9K
Mass spectrometry is a powerful characterization technique that can identify and separate a wide variety of compounds ranging from chemical to biological entities, based on their mass-to-charge ratio (m/z). The instruments that allow this detection, known as mass spectrometers, have three components: an ion source, a mass analyzer, and a detector. These spectrometers differ based on the nature of their ion source and analyzers.
Matrix-assisted laser desorption ionization (MALDI) is a commonly...
Matrix-assisted laser desorption ionization (MALDI) is a commonly...
4.9K
Mass Spectrometry: Isotope Effect
2.2K
Most elements exist in nature as a mixture of isotopes. The isotopes differ in weight due to their respective number of neutrons. The molecular weight of a molecule is different depending on the specific isotope of its elements involved. As a result, the mass spectrum of the molecule exhibits peaks from the same fragment at multiple positions. The positions of these mass signals depend on the difference between the molecular mass. Furthermore, the intensity of these signals is dependent on the...
2.2K


