How to draw the line - Raman spectroscopy as a tool for the assessment of biomedicines

被引:4
作者
Kamp, Christel [1 ]
Becker, Bjoern [1 ]
Matheis, Walter [1 ]
Oeppling, Volker [1 ]
Bekeredjian-Ding, Isabelle [1 ]
机构
[1] Paul Ehrlich Inst, Paul Ehrlich Str 51-59, D-63225 Langen, Germany
关键词
machine learning; pre-processing; quality control; Raman spectroscopy; standardisation; vaccine; SPECTRA;
D O I
10.1515/hsz-2020-0388
中图分类号
Q5 [生物化学]; Q7 [分子生物学];
学科分类号
071010 ; 081704 ;
摘要
Biomedicines are complex biochemical formulations with multiple components that require extensive quality control during manufacturing and in subsequent batch testing. A proof-of-concept study has shown that an application of Raman spectroscopy can be beneficial for a classification of vaccines. However, the complexity of biomedicines introduces new challenges to spectroscopic methodology that require advanced experimental protocols. We further show the impact of analytical protocols on vaccine classification using R as an Open Source data analysis platform. In conclusion, we advocate for standardized and transparent experimental and analytical procedures and discuss current findings and open challenges.
引用
收藏
页码:1001 / 1006
页数:6
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