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

Autor: R.A. Grosso, A.R. Walther, E. Brunbech, A. Sørensen, B. Schebye, K.E. Olsen, H. Qu, M.A.B. Hedegaard, E. C. Arnspang

Sterility testing is a laborious and slow process to detect contaminants present in drug products. Raman spectroscopy is a promising label-free tool to detect microorganisms and thus gaining relevance as future alternative culture-free method for ste

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::8a9a6b3f6d4293db94f05f07592cbb1d
https://doi.org/10.1101/2022.04.26.489535

Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation.

Autor: Deutschmann S; Roche Diagnostics GmbH, Penzberg, Germany., Paul M; Merck & Co., Inc., Kenilworth, NJ., Claassen-Willemse M; MSD, Oss, The Netherlands., van den Berg J; Roche Diagnostics GmbH, Mannheim, Germany., IJzerman-Boon P; MSD, Oss, The Netherlands., Grunert da Fonseca V; Roche Diagnostics GmbH, Penzberg, Germany., Brunbech E; Novo Nordisk A/S, Bagsvaerd, Denmark., Johnson L; Takeda, Lexington, MA., Knutsen C; Bristol-Myers Squibb, New Brunswick, NJ., Plourde L; Sanofi Pasteur, Marcy-l'Etoile, France., Salvas J; Pfizer, Kirkland, QC, Canada; and., Villari P; Merck & Co., Inc., Kenilworth, NJ., Wysocki L; GlaxoSmithKline, Collegeville, PA.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2023 May-Jun; Vol. 77 (3), pp. 211-235. Date of Electronic Publication: 2023 Jan 25.