Toward biosimilar monoclonal antibodies

被引：79

作者：

Schneider, Christian K. ^{[1
]}

Kalinke, Ulrich ^{[2
,3
]}

机构：

[1] Paul Ehrlich Inst, Fed Agcy Sera & Vaccines, Div EU Cooperat Microbiol, D-63225 Langen, Germany

[2] Paul Ehrlich Inst, Div Immunol, D-30625 Hannover, Germany

[3] Twincore Ctr Expt & Clin Infect Res, D-30625 Hannover, Germany

来源：

NATURE BIOTECHNOLOGY | 2008年 / 26卷 / 09期

关键词：

D O I：

10.1038/nbt0908-985

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies?

引用

页码：985 / 990

页数：6

共 14 条

[1] Characterization by liquid chromatography combined with mass spectrometry of monoclonal anti-IGF-1 receptor antibodies produced in CHO and NSO cells [J].

Beck, A ;

Bussat, MC ;

Zorn, N ;

Robillard, V ;

Klinguer-Hamour, C ;

Chenu, S ;

Goetsch, L ;

Corvaïa, N ;

Van Dorsselaer, A ;

Haeuw, JF .

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2005, 819 (02) :203-218

[2] Potent antibody therapeutics by design [J].

Carter, PJ .

NATURE REVIEWS IMMUNOLOGY, 2006, 6 (05) :343-357

[3] Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. [J].

Casadevall, N ;

Nataf, J ;

Viron, B ;

Kolta, A ;

Kiladjian, J ;

Martin-Dupont, P ;

Michaud, P ;

Papo, T ;

Ugo, V ;

Teyssandier, I ;

Varet, B ;

Mayeux, P .

NEW ENGLAND JOURNAL OF MEDICINE, 2002, 346 (07) :469-475

[4] Characterizing biological products and assessing comparability following manufacturing changes [J].

Chirino, AJ ;

Mire-Sluis, A .

NATURE BIOTECHNOLOGY, 2004, 22 (11) :1383-1391

[5] Antibody humanization: a case of the 'Emperor's new clothes'? [J].

Clark, M .

IMMUNOLOGY TODAY, 2000, 21 (08) :397-402

[6]

*EUR PHARM, 2008, MON EUR PHARM, V784

[7]

*EUR PHARM, 2008, MON EUR PHARM, V2031

[8] NMR structure of the bovine prion protein [J].

Garcia, FL ;

Zahn, R ;

Riek, R ;

Wüthrich, K .

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2000, 97 (15) :8334-8339

[9] Analysis of carbohydrates and glycoconjugates by matrix-assisted laser desorption/ionization mass spectrometry: An update covering the period 2001-2002 [J].

Harvey, David J. .

MASS SPECTROMETRY REVIEWS, 2008, 27 (02) :125-201

[10] Capillary electrophoresis for the analysis of biopolymers [J].

Hu, S ;

Dovichi, NJ .

ANALYTICAL CHEMISTRY, 2002, 74 (12) :2833-2850

← 1 2 →