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Characterizing biological products and assessing comparability following manufacturing changes

Author
CHIRINO, Arthur J1 ; MIRE-SLUIS, Anthony2
[1] Xencor Inc., 111 West Lemon Avenue, Monrovia, Calfornia 91016, United States
[2] Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, 1451 Rockville Pike, Maryland 20852, United States
Source

Nature biotechnology. 2004, Vol 22, Num 11, pp 1383-1391, 9 p ; ref : 91 ref

CODEN
NABIF9
ISSN
1087-0156
Scientific domain
Biotechnology
Publisher
Nature, New York, NY
Publication country
United States
Document type
Article
Language
English
Keyword (fr)
Activité biologique Efficacité Procédé fabrication Produit biologique Protéine Pureté Sécurité
Keyword (en)
Biological activity Efficiency Manufacturing process Organic product Protein Purity Safety
Keyword (es)
Actividad biológica Eficacia Procedimiento fabricación Producto biológico Proteína Pureza Seguridad
Classification
Pascal
002 Biological and medical sciences / 002A Fundamental and applied biological sciences. Psychology / 002A31 Biotechnology / 002A31D Industrial applications and implications. Economical aspects / 002A31D01 Health. Pharmaceutical industry / 002A31D01C Production of active biomolecules / 002A31D01C8 Other active biomolecules

Discipline
Biotechnology
Origin
Inist-CNRS
Database
PASCAL
INIST identifier
16281401

Sauf mention contraire ci-dessus, le contenu de cette notice bibliographique peut être utilisé dans le cadre d’une licence CC BY 4.0 Inist-CNRS / Unless otherwise stated above, the content of this bibliographic record may be used under a CC BY 4.0 licence by Inist-CNRS / A menos que se haya señalado antes, el contenido de este registro bibliográfico puede ser utilizado al amparo de una licencia CC BY 4.0 Inist-CNRS

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