Image Classification of Degraded Polysorbate, Protein and Silicone Oil Sub-Visible Particles Detected by Flow-Imaging Microscopy in Biopharmaceuticals Using a Convolutional Neural Network Model.

Fedorowicz, Filip M; Chalus, Pascal; Kirschenbühler, Kyra; Drewes, Sarah; Koulov, Atanas

Fedorowicz, Filip M; Chalus, Pascal; Kirschenbühler, Kyra; Drewes, Sarah; Koulov, Atanas.

Afiliação

Fedorowicz FM; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, 4057 Basel, Switzerland; Current affiliation: Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland.
Chalus P; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, 4057 Basel, Switzerland. Electronic address: pascal.chalus@lonza.com.
Kirschenbühler K; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, 4057 Basel, Switzerland; ETH Zurich, Department of Biosystems Science and Engineering, Mattenstrasse 26, 4058 Basel, Switzerland.
Drewes S; Mathworks GmbH, Weihenstephaner Str. 6, 81673 München, Germany.
Koulov A; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, 4057 Basel, Switzerland; Current affiliation: Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland.

J Pharm Sci ; 112(12): 3099-3108, 2023 12.

Article em En | MEDLINE | ID: mdl-37422283

Assuntos

Produtos Biológicos; Polissorbatos; Óleos de Silicone; Microscopia/métodos; Química Farmacêutica/métodos; Tamanho da Partícula; Proteínas; Ácidos Graxos não Esterificados; Redes Neurais de Computação

Palavras-chave

Artificial Intelligence; Convolutional neural network; Flow imaging; Free-fatty acid; Image analysis; Protein formulation; Sub-visible particles; Surfactant degradation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Polissorbatos / Produtos Biológicos Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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