使用电荷检测质谱仪对AAV制造过程进行端到端的表征
Lohra M Young1, Benjamin E Draper1, Martin F Jarrold1
1Megadalton Solutions, Inc., Bloomington, IN 47404, USA.
Molecular therapy. Methods & clinical development
|November 26, 2025
概括
电荷检测质谱 (CD-MS) 在整个制造过程中有效监测复合腺相关病毒 (rAAV) 的质量. 这种技术为从收获到最终药物物质的rAAV生产提供了可重复的定量洞察力.
科学领域:
- 生物制药学分析
- 质谱测量质量谱测量
- 过程分析技术 过程分析技术
背景情况:
- 复合腺相关病毒 (rAAV) 对于基因疗法至关重要.
- 在制造过程中监测rAAV的质量属性至关重要.
- 现有的分析方法可能对过程中的rAAV评估有局限性.
研究的目的:
- 评估电荷检测质谱法 (CD-MS) 用于分析rAAV质量属性.
- 为了证明CD-MS在工艺过程中的RAAV监测能力,从收获到药物物质.
- 评估CD-MS用于rAAV生产的可复制性和定量准确性.
主要方法:
- 利用CD-MS在各种生产阶段分析rAAV样本:批量采集,亲和染色学和离子交换染色学.
- 使用本地电喷射电离化的 rAAV 质量和电荷分布的特征.
- 根据质量和电荷特征分离和分析rAAV离子.
主要成果:
- CD-MS成功地描述了rAAV的质量范围,与理论值保持一致.
- 在收获和净化样品之间观察到一致的空/部分/全rAAV比率.
- 在每个生产阶段检测和量化过程杂质.
- CD-MS在跟踪rAAV生产方面表现出高的可复制性.
结论:
- CD-MS是一种强大的工具,用于在制造过程中评估和监测rAAV的质量属性.
- 该技术提供了定量和可重复的结果,使得有效的过程跟踪.
- CD-MS支持从早期收获到最终散装药物物质的质量控制.
更多相关视频
05:53A Step-By-Step Method to Detect Neutralizing Antibodies Against AAV using a Colorimetric Cell-Based Assay
Published on: December 7, 2021
5.2K
14:49A Quantitative Dot Blot Assay for AAV Titration and Its Use for Functional Assessment of the Adeno-associated Virus Assembly-activating Proteins
Published on: June 12, 2018
14.3K
相关概念视频
Peptide Identification Using Tandem Mass Spectrometry
8.1K
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...
8.1K
Mass Spectrometers
8.2K
This lesson details the instrumentation of a mass spectrometer—a physical instrument to perform mass spectrometry on analyte molecules and record the characteristic mass spectra. This is achieved via three chief functions:
8.2K
Tandem Mass Spectrometry
2.3K
Tandem mass spectrometry is a technique that uses multiple mass analyzers in series to obtain a higher selectivity and reduce chemical noise during analyte detection. Instruments with multiple analyzers separated by an interaction cell enable secondary fragmentation and selected study of the fragment ions.Secondary fragmentations occur in the interaction cell and can be induced by various factors. Fragmentation induced by collision with inert gases, such as N2, Ar, He, etc., is called...
2.3K
MALDI-TOF Mass Spectrometry
6.4K
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...
6.4K
Mass Spectrometry of Amines
5.3K
In mass spectroscopy, amines undergo fragmentation to give parent ions with odd molecule weights. This observed mass spectrum follows the nitrogen rule; a molecule with an odd number of nitrogen atoms produces a molecular ion with an odd molecular weight. Amines undergo fragmentation through α cleavage, producing nitrogen-containing cations—iminium ions—and alkyl radicals. Mass spectra of aromatic and cyclic aliphatic amines exhibit strong molecular ion peaks, but acyclic...
5.3K
Mass Analyzers: Common Types
1.3K
The quadrupole mass analyzer consists of four cylindrical metal rods arranged in a diamond carrying a DC voltage and a radio-frequency AC voltage. The motion of ions through the quadrupole depends on the field strength, causing only ions of a certain m/z to resonate successfully and strike the detector at a given field strength. Though the transmission rate for these analyzers is high, the exact elemental composition of the sample is not determined because of low resolution; however, they are...
1.3K
