Detection of low numbers of bacterial cells in a pharmaceutical drug product using Raman spectroscopy and PLS-DA multivariate analysis-Reference-Cited by-同舟云学术

Detection of low numbers of bacterial cells in a pharmaceutical drug product using Raman spectroscopy and PLS-DA multivariate analysis

Published:2022 Issue:15 Volume:147 Page:3593-3603
ISSN:0003-2654
Container-title:The Analyst
language:en
Short-container-title:Analyst

Author:

Grosso R. A.¹²^ORCID,Walther A. R.¹,Brunbech E.²,Sørensen A.²,Schebye B.³^ORCID,Olsen K. E.²,Qu H.¹,Hedegaard M. A. B.¹,Arnspang E. C.¹^ORCID

Affiliation:

1. Department of Green Technology, SDU- Biotechnology, University of Southern Denmark, Odense, Denmark

2. Product Supply Injectable Finished Products, Microbial Competence Centre, Novo Nordisk A/S, Copenhagen, Denmark

3. Product Supply Injectable Finished Products, Technology Innovation, Novo Nordisk A/S, Copenhagen, Denmark

Abstract

Fast and non-invasive approach to detect drug product (DP) samples with low numbers of bacteria within the primary packaging. The method combines Raman spectroscopy and partial least squared discriminant analysis (RS-PLS-DA).

Funder

Novo Nordisk

Villum Fonden

Publisher

Royal Society of Chemistry (RSC)

Subject

Electrochemistry,Spectroscopy,Environmental Chemistry,Biochemistry,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2022/AN/D2AN00683A

Reference46 articles.

1. WHO , Annex 7. Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals , 2003

2. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing

3. Comprehensive Evaluation of Compendial USP<71>, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants

4. Validation Study of Rapid Assays of Bioburden, Endotoxins and Other Contamination

5. Microbial contamination of nonsterile pharmaceuticals in public hospital settings

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Raman spectroscopy as an alternative rapid microbial bioburden test method for continuous, automated detection of contamination in biopharmaceutical drug substance manufacturing;Journal of Applied Microbiology;2024-07-25

2. Quantitative Analysis of Biodiesel Adulterants Using Raman Spectroscopy Combined with Synergy Interval Partial Least Squares (siPLS) Algorithms;Applied Sciences;2023-10-14

3. A Monte Carlo resampling based multiple feature-spaces ensemble (MFE) strategy for consistency-enhanced spectral variable selection;Analytica Chimica Acta;2023-10

4. Raman Spectroscopy Application in Food Waste Analysis: A Step towards a Portable Food Quality-Warning System;Sustainability;2022-12-22