A European perspective on immunogenicity evaluation

Nature Biotechnology

Volumn 27, Issue 6, 2009, Pages 507-508

  Schneider, Christian K ^a,c   Papaluca, Marisa ^b   Kurki, Pekka ^d  

^a PAUL EHRLICH INSTITUT   (Germany)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

^d NATIONAL AGENCY FOR MEDICINES   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; BETA INTERFERON; CYTOKINE ANTIBODY; ERYTHROPOIETIN; PROTEIN; TUMOR NECROSIS FACTOR ALPHA;

ANTIBODY PRODUCTION; BIOTECHNOLOGICAL PRODUCTION; EUROPE; EVALUATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; LETTER; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEIN BINDING; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

ANTIBODY FORMATION; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; EUROPE; GUIDELINES AS TOPIC; HUMANS; RECOMBINANT PROTEINS; RISK ASSESSMENT;

EID: 67149120783     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt0609-507     Document Type: Letter

References (4)

1. shankar, G., pendley, c. & stein, K.e. Nat. Biotechnol. 25, 555-561 (2007).
2. european Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic proteins eMeA/cHMp/BMWp/14327/2006.
3. BMWp/BWp Workshop on Immunogenicity Assessment of Therapeutic proteins, eMeA, London, september 4, 2007.
4. european Medicines Agency. european public Assessment Report (epAR) for Remicade.