A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: A European industry perspective

Journal of Immunological Methods

Volumn 417, Issue , 2015, Pages 1-9

  Kloks, Cathelijne ^a   Berger, Claudia ^b   Cortez, Pierre ^c   Dean, Yann ^d   Heinrich, Julia ^e   Bjerring Jensen, Lisbeth ^f   Koppenburg, Vera ^g   Kostense, Stefan ^h   Kramer, Daniel ⁱ   Spindeldreher, Sebastian ^j   Kirby, Hishani ^k  

^a Dept of Analytical Development and Validation ^*  (Netherlands)

^b ABBOTT GMBH AND CO KG   (Germany)

^c SANOFI   (France)

^d NOVIMMUNE SA   (Switzerland)

^e ROCHE DIAGNOSTICS GMBH   (Germany)

^f NOVO NORDISK A S   (Denmark)

^g Sandoz Biopharmaceuticals   (Germany)

^h CRUCELL HOLLAND BV   (Netherlands)

ⁱ Sanofi Diabetes Global Medical Department   (Germany)

^j Novartis Pharma AG   (Switzerland)

^k UCB PHARMA   (Belgium)

more..

Author keywords

Anti drug antibodies; Biologicals; Biotherapeutic; Immunogenicity; Neutralization; Risk based approach

Indexed keywords

DRUG ANTIBODY; NEUTRALIZING ANTIBODY;

DRUG DEVELOPMENT; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SAMPLING; SCREENING; ADVERSE DRUG REACTION; ADVERSE EFFECTS; BIOLOGICAL THERAPY; DRUG DESIGN; DRUG INDUSTRY; DRUG SCREENING; EUROPE; IMMUNOLOGICAL PROCEDURES; IMMUNOLOGY; PRACTICE GUIDELINE; PROCEDURES; STANDARDS; TRENDS;

ANTIBODIES, NEUTRALIZING; BIOLOGICAL THERAPY; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; GUIDELINES AS TOPIC; HUMANS; IMMUNOLOGIC TESTS;

EID: 84922985612     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2015.01.003     Document Type: Review

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