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Titolo:
Progress in the use of biological assays during the development of biotechnology products
Autore:
Mire-Sluis, AR;
Indirizzi:
Genentech Inc, S San Francisco, CA 94080 USA Genentech Inc S San Francisco CA USA 94080 S San Francisco, CA 94080 USA
Titolo Testata:
PHARMACEUTICAL RESEARCH
fascicolo: 9, volume: 18, anno: 2001,
pagine: 1239 - 1246
SICI:
0724-8741(200109)18:9<1239:PITUOB>2.0.ZU;2-Y
Fonte:
ISI
Lingua:
ENG
Soggetto:
REPORTER GENE ASSAY; THERAPEUTIC PRODUCTS; BIOASSAYS; CYTOKINES; ANTIBODY; STANDARDIZATION; VALIDATION; PROTEIN;
Keywords:
biotechnology; biological assays; immunogenicity; analytical; therapeutics;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
41
Recensione:
Indirizzi per estratti:
Indirizzo: Mire-Sluis, AR Genentech Inc, 1 DNA Way, S San Francisco, CA 94080 USA Genentech Inc 1 DNA Way S San Francisco CA USA 94080 80 USA
Citazione:
A.R. Mire-Sluis, "Progress in the use of biological assays during the development of biotechnology products", PHARM RES, 18(9), 2001, pp. 1239-1246

Abstract

The complexity of the structure and function of many biotechnology derivedproducts necessitates a wide range of analytical procedures to adequately characterize the product. In-depth characterization is required for the assessment of several criteria vital to the success of product development such as consistency, purity, stability, and potency. More recently, the concern over the immunogenicity of biologics has increased the need to develop assays to detect neutralizing anti-product antibodies. Although many physicochemical tests are available to characterize the structure of a protein and detect the presence of contaminants, they provide little, if any, information regarding biological potency or the neutralizing capacity of antibody responses in immunogenicity studies. There is a continual need to refine biological assays to increase their accuracy and reproducibility, in particularto replace in vivo bioassays with appropriate in vitro assays. There have also been several recent technological developments that could lead to morerapid and reproducible bioassays.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 05/04/20 alle ore 00:26:50