In vitro and in vivo immunogenicity assessment of protein aggregate characteristics.

Thorlaksen, Camilla; Schultz, Heidi S; Gammelgaard, Simon K; Jiskoot, Wim; Hatzakis, Nikos S; Nielsen, Flemming S; Solberg, Helene; Foderà, Vito; Bartholdy, Christina; Groenning, Minna

Thorlaksen, Camilla; Schultz, Heidi S; Gammelgaard, Simon K; Jiskoot, Wim; Hatzakis, Nikos S; Nielsen, Flemming S; Solberg, Helene; Foderà, Vito; Bartholdy, Christina; Groenning, Minna.

Afiliação

Thorlaksen C; Biophysical analysis, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark; Department of Pharmacy and Nanoscience Center, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
Schultz HS; Screening and Bioassay Technology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark.
Gammelgaard SK; MS characterization, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark.
Jiskoot W; Division of BioTherapeutics, Leiden University, Einsteinweg 55, 2300 RA Leiden, Netherlands.
Hatzakis NS; Department of Chemistry and Nanoscience Center, University of Copenhagen, Universitetsparken 5, 2100 Copenhagen, Denmark; Novo Nordisk Foundation Center for Protein Research, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.
Nielsen FS; Discovery & Development PKPD, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark.
Solberg H; Clinical Immunogenicity analysis, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark.
Foderà V; Department of Pharmacy and Nanoscience Center, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark. Electronic address: vito.fodera@sund.ku.dk.
Bartholdy C; Screening and Bioassay Technology, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark; In Vivo Biology and Biomarkers, LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark (Current).
Groenning M; Biophysical analysis, Novo Nordisk A/S, Novo Nordisk Park 1, 2760 Måløv, Denmark. Electronic address: mgqj@novonordisk.com.

Int J Pharm ; 631: 122490, 2023 Jan 25.

Article em En | MEDLINE | ID: mdl-36521637

Assuntos

Agregados Proteicos; Humanos

Palavras-chave

Aggregate; Anti-drug antibody; Human insulin; Immunogenicity; Particles

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Agregados Proteicos Limite: Humans Idioma: En Revista: Int J Pharm Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Dinamarca

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