Building better drugs: Developing and regulating engineered therapeutic proteins

Trends in Pharmacological Sciences

Volumn 34, Issue 10, 2013, Pages 534-548

  Kimchi Sarfaty, Chava ^a   Schiller, Tal ^a   Hamasaki Katagiri, Nobuko ^a   Khan, Mansoor A ^b   Yanover, Chen ^c,d   Sauna, Zuben E ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d IBM HAIFA RESEARCH LAB   (Israel)

Author keywords

drug development; drug safety; immunogenicity; quality by design; risk mitigation

Indexed keywords

ABATACEPT; AFLIBERCEPT; ALBIGLUTIDE; ALBINTERFERON ALPHA2B; ALEFACEPT; ASPARAGINASE MACROGOL; ATACICEPT; BELATACEPT; ETANERCEPT; ETIRINOTECAN PEGOL; FIRTECAN PEGOL; HYBRID PROTEIN; INSULIN ASPART; INSULIN DEGLUDEC; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN LISPRO; INTERFERON BETA SERINE; NALOXEGOL; NEULASTIM; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGADEMASE; PEGINESATIDE; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PEGLOTICASE; PEGVISOMANT; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 2; RILONACEPT; ROMIPLOSTIM; TREBANANIB; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZIFERON;

BIOTECHNOLOGY; DRUG DESIGN; DRUG HALF LIFE; DRUG RESEARCH; HUMAN; IMMUNE RESPONSE; MAJOR HISTOCOMPATIBILITY COMPLEX; NONHUMAN; PHARMACOGENETICS; PLASMA HALF LIFE; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PROTEIN ENGINEERING; PROTEIN EXPRESSION; PROTEIN INTERACTION; PROTEIN MODIFICATION; PROTEIN PROCESSING; PROTEIN STRUCTURE; REGULATORY MECHANISM; REVIEW;

EID: 84885176016     PISSN: 01656147     EISSN: 18733735     Source Type: Journal    
DOI: 10.1016/j.tips.2013.08.005     Document Type: Review

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