Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

Journal of Immunological Methods

Volumn 333, Issue 1-2, 2008, Pages 1-9

  Koren, Eugen ^a   Smith, Holly W ^b   Shores, Elizabeth ^c   Shankar, Gopi ^d   Finco Kent, Deborah ^e   Rup, Bonita ^e   Barrett, Yu Chen ^f   Devanarayan, Viswanath ^g   Gorovits, Boris ^h   Gupta, Shalini ⁱ   Parish, Thomas ^j   Quarmby, Valerie ^k   Moxness, Michael ⁱ   Swanson, Steven J ⁱ   Taniguchi, Gary ^l   Zuckerman, Linda A ^m   Stebbins, Christopher C ^k   Mire Sluis, Anthony ⁱ  

^a ABBOTT VASCULAR   (United States)

^b ELI LILLY AND COMPANY   (United States)

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

^d CENTOCOR INC   (United States)

^e PFIZER INC   (United States)

^f BRISTOL MYERS SQUIBB   (United States)

^g MERCK RESEARCH LABORATORIES   (United States)

^h WYETH RESEARCH   (United States)

ⁱ AMGEN INC   (United States)

^j PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

^k GENENTECH INC   (United States)

^l PDL BioPharma Inc   (United States)

^m ZYMOGENETICS INC   (United States)

more..

Author keywords

Immunogenicity testing; Risk assessment; Therapeutic proteins

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ANTINEOPLASTIC AGENT; CARBOPLATIN; DRUG ANTIBODY; GLIAL CELL LINE DERIVED NEUROTROPHIC FACTOR; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; INFLIXIMAB; MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR; NATALIZUMAB; NEUTRALIZING ANTIBODY; RECOMBINANT THROMBOPOIETIN;

ANAPHYLAXIS; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY SCREENING; BIOTECHNOLOGY; CLINICAL TRIAL; CROHN DISEASE; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERANCE; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; EXANTEMA; GYNECOLOGIC CANCER; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; INJECTION SITE REACTION; MULTIPLE CYCLE TREATMENT; NONHUMAN; PRIORITY JOURNAL; PSORIASIS; REVIEW; RISK ASSESSMENT; SKIN INFLAMMATION; THROMBOCYTOPENIA;

ANIMALS; ANTIBODIES; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; HUMANS; RISK ASSESSMENT;

EID: 41349116947     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2008.01.001     Document Type: Review

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