Implementing quality by design for biotech products: Are regulators on track?

Luciani, Francesca; Galluzzo, Sara; Gaggioli, Andrea; Kruse, Nanna Aaby; Venneugues, Pascal; Schneider, Christian K; Pini, Carlo; Melchiorri, Daniela

Luciani, Francesca; Galluzzo, Sara; Gaggioli, Andrea; Kruse, Nanna Aaby; Venneugues, Pascal; Schneider, Christian K; Pini, Carlo; Melchiorri, Daniela.

Afiliación

Luciani F; a National Center for Immunobiologicals Control and Evaluation (CRIVIB); Istituto Superiore di Sanità ; Rome , Italy.

MAbs ; 7(3): 451-5, 2015.

Article en En | MEDLINE | ID: mdl-25853461

Asunto(s)

Anticuerpos Monoclonales; Biotecnología/normas; Biotecnología/métodos; Unión Europea; Humanos; Control de Calidad

Palabras clave

BWP, Biologics Working Party; CHMP, Committee for Medicinal Products for Human Use; CPPs, critical process parameters; CQAs, critical quality attributes; EMA, European Medicines Agency; QTPP, Quality Target Product Profile; QbD, quality by design; quality by design, biotech product

Texto completo

Imprimir

XML

PubMed Links

Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Biotecnología / Anticuerpos Monoclonales Límite: Humans Idioma: En Revista: MAbs Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2015 Tipo del documento: Article País de afiliación: Italia

Texto completo

Imprimir

XML

PubMed Links

Buscar en Google