Early implementation of QbD in biopharmaceutical development: A practical example

BioMed Research International

Volumn 2015, Issue , 2015, Pages

  Zurdo, Jesús ^a   Arnell, Andreas ^a   Obrezanova, Olga ^a   Smith, Noel ^a   Gómez De La Cuesta, Ramón ^a   Gallagher, Thomas R A ^a   Michael, Rebecca ^a   Stallwood, Yvette ^a   Ekblad, Caroline ^b   Abrahmsén, Lars ^b   Höidén Guthenberg, Ingmarie ^b  

^a New Expression Technologies Group   (United Kingdom)

^b Affibody AB   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ABD001; ABD035; ABD088; ABD094; ABD095; BETA1A INTERFERON; BIOLOGICAL PRODUCT; HUMAN ALBUMIN; KEYHOLE LIMPET HEMOCYANIN; RECOMBINANT ERYTHROPOIETIN; TGN 1412; UNCLASSIFIED DRUG;

BIOLOGICAL ACTIVITY; COST EFFECTIVENESS ANALYSIS; CYTOKINE RELEASE SYNDROME; DRUG DEVELOPMENT; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG RESEARCH; HUMAN; IMMUNOGENICITY; METHODOLOGY; MULTIPLE ORGAN FAILURE; MULTIPLE SCLEROSIS; NONHUMAN; PATIENT SAFETY; PHARMACOLOGY; PRODUCTIVITY; REVIEW; RISK ASSESSMENT; WORKFLOW; DRUG DESIGN; DRUG INDUSTRY; PHARMACEUTICS; PROCEDURES;

BIOPHARMACEUTICS; DRUG DESIGN; DRUG INDUSTRY; HUMANS;

EID: 84930674518     PISSN: 23146133     EISSN: 23146141     Source Type: Journal    
DOI: 10.1155/2015/605427     Document Type: Review

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