GENETIC STABILITY AND RECOMBINANT PRODUCT CONSISTENCY

被引：2

作者：

BURSTYN, D

COPMANN, T

DINOWITZ, M

GARNICK, R

LOSIKOFF, A

LUBINIECKI, A

WIEBE, M

机构：

[1] PHARMACEUT MANUFACTURERS ASSOC, WASHINGTON, DC USA

[2] GENENTECH INC, San Francisco, CA 94080 USA

[3] TSI, KENSINGTON, CT USA

[4] SMITHKLINE BEECHAM, KING OF PRUSSIA, PA USA

来源：

BIOLOGICALS | 1993年 / 21卷 / 02期

关键词：

D O I：

10.1006/biol.1993.1064

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Abstract. A committee of U.S. industry scientists from the Pharmaceutical Manufacturers Association has reviewed the recent suggestions of Galibert and Center for Biologics Evaluation and Research (CBER) regarding assurances of product consistency by cloning and sequencing efforts. We disagree that their proposals will achieve this goal, and estimate that such efforts will be very costly in terms of regulatory agency time examining artifactual errors as well as industry resources. We feel that current analytical and manufacturing technology is adequate to assure recombinant product consistency without the suggested cloning and sequencing measures. © 1993 Academic Press, Inc.

引用

页码：147 / 149

页数：3

共 10 条

[1] STABILITY OF A GENE RECOMBINANT - WHAT DOES IT MEAN AND HOW TO CHECK FOR IT [J].