Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release and cGMP Purity Testing at the Peptide and Intact Protein Level.

Millán-Martín, Silvia; Jakes, Craig; Carillo, Sara; Gallagher, Lizzie; Scheffler, Kai; Broster, Kelly; Bones, Jonathan

Millán-Martín, Silvia; Jakes, Craig; Carillo, Sara; Gallagher, Lizzie; Scheffler, Kai; Broster, Kelly; Bones, Jonathan.

Afiliação

Millán-Martín S; National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Co, Dublin, Ireland.
Jakes C; National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Co, Dublin, Ireland.
Carillo S; National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Co, Dublin, Ireland.
Gallagher L; Thermo Fisher Scientific, Stafford House, Hemel Hempstead, UK.
Scheffler K; Thermo Fisher Scientific, Germering, Germany.
Broster K; Thermo Fisher Scientific, Stafford House, Hemel Hempstead, UK.
Bones J; National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Co, Dublin, Ireland.

Crit Rev Anal Chem ; : 1-18, 2023 Jul 25.

Article em En | MEDLINE | ID: mdl-37490277

Palavras-chave

Biotherapeutics; HRAM; NPD; QC; critical quality attributes; multi-attribute method

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Texto completo: 1 Bases de dados: MEDLINE Idioma: En Revista: Crit Rev Anal Chem Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Irlanda