Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment.

Dyck, Yan Felix Karl; Rehm, Daniel; Joseph, Jan Felix; Winkler, Karsten; Sandig, Volker; Jabs, Wolfgang; Parr, Maria Kristina

Dyck, Yan Felix Karl; Rehm, Daniel; Joseph, Jan Felix; Winkler, Karsten; Sandig, Volker; Jabs, Wolfgang; Parr, Maria Kristina.

Afiliação

Dyck YFK; Department of Pharmaceutical & Medicinal Chemistry, Institute of Pharmacy, Freie Universität Berlin, Königin-Luise-Straße 2+4, 14195 Berlin, Germany.
Rehm D; Department of Life Sciences & Technology, Beuth Hochschule für Technik Berlin, Seestraße 64, 13347 Berlin, Germany.
Joseph JF; Department of Pharmaceutical & Medicinal Chemistry, Institute of Pharmacy, Freie Universität Berlin, Königin-Luise-Straße 2+4, 14195 Berlin, Germany.
Winkler K; ProBioGen AG, Goethestraße 54, 13086 Berlin, Germany.
Sandig V; Department of Pharmaceutical & Medicinal Chemistry, Institute of Pharmacy, Freie Universität Berlin, Königin-Luise-Straße 2+4, 14195 Berlin, Germany.
Jabs W; Core Facility BioSupraMol, Institute of Pharmacy, Freie Universität Berlin, Königin-Luise-Str. 2+4, 14195 Berlin, Germany.
Parr MK; ProBioGen AG, Goethestraße 54, 13086 Berlin, Germany.

Bioengineering (Basel) ; 6(3)2019 Jul 21.

Article em En | MEDLINE | ID: mdl-31330921

Palavras-chave

QTOF-MS; bevacizumab; biopharmaceuticals; biosimilar; forced stability testing; infliximab; liquid chromatography-mass spectrometry (LC-MS); middle-up approach; structure reactivity relationship

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Bioengineering (Basel) Ano de publicação: 2019 Tipo de documento: Article

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Bioengineering (Basel) Ano de publicação: 2019 Tipo de documento: Article