相关实验视频

Updated: Jul 10, 2025

Surface Enhanced Raman Spectroscopy Detection of Biomolecules Using EBL Fabricated Nanostructured Substrates

Surface Enhanced Raman Spectroscopy Detection of Biomolecules Using EBL Fabricated Nanostructured Substrates

Published on: March 20, 2015

形态定向拉曼光谱作为治疗蛋白质产品质量中可见粒子表征的分析方法

Minkyung Kim¹, Youlong Ma², Charudharshini Srinivasan²

¹Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Scientific reports

|November 22, 2023

概括

形态定向拉曼光谱法 (MDRS) 为治疗性蛋白质 (TP) 提供了先进的可见微粒 (SVP) 特性. 该技术提供化学识别和形态数据,补充现有的质量控制方法.

科学领域:

分析化学分析化学
生物制药科学生物制药科学
材料科学材料科学材料科学

背景情况:

微可见粒子 (SVP) 是可注射治疗蛋白质 (TP) 的关键质量属性.
目前用于SVP分析的方法提供了尺寸和计数,但缺乏化学识别.
对SVP的根本原因分析需要详细的化学和形态特征.

研究的目的:

引入和验证形态定向拉曼光谱法 (MDRS) 用于TP中的SVP表征.
为了证明MDRS对单个SVP的化学识别的能力.
评估MDRS作为TP质量控制工作流程中的补充工具.

主要方法:

使用聚烯微球,SU-8和乙烯四乙烯 (ETFE) 颗粒的方法开发.
应用MDRS用于SVP的高分辨率成像和拉曼光谱.
用流成像显微镜对MDRS形态数据进行比较.
压力TP中的颗粒的表征.

主要成果:

MDRS提供了ETFE粒子 (19-100μm) 的高分辨率图像,与流影像显微镜相似.
该方法使得使用拉曼光谱学在应力TP中单个SVP的化学识别成为可能.
MDRS成功地将蛋白质颗粒的形态和透明度与参考材料进行了比较.

结论:

MDRS是一种强大的技术,用于对TP进行详细的SVP表征.
它提供化学识别和形态洞察,补充现有的分析方法.
在TP开发和商业生命周期中,MDRS可以提高产品质量表征.

更多相关视频

An Integrated Raman Spectroscopy and Mass Spectrometry Platform to Study Single-Cell Drug Uptake, Metabolism, and Effects

An Integrated Raman Spectroscopy and Mass Spectrometry Platform to Study Single-Cell Drug Uptake, Metabolism, and Effects

Published on: January 9, 2020

Surface-enhanced Resonance Raman Scattering Nanoprobe Ratiometry for Detecting Microscopic Ovarian Cancer via Folate Receptor Targeting

Surface-enhanced Resonance Raman Scattering Nanoprobe Ratiometry for Detecting Microscopic Ovarian Cancer via Folate Receptor Targeting

Published on: March 25, 2019

相关概念视频

Raman Spectroscopy Instrumentation: Overview

Raman Spectroscopy Instrumentation: Overview

A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...

Raman Spectroscopy: Overview

Raman Spectroscopy: Overview

The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...