Genetic Stability and Recombinant Product Consistency

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 prop...

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Veröffentlicht in:	Biologicals 1993-06, Vol.21 (2), p.147-149
Hauptverfasser:	Burstyn, D., Copmann, T., Dinowitz, M., Garnick, R., Losikoff, A., Lubiniecki, A., Wiebe, M.
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Biological Products - genetics Biological Products - standards Cloning, Molecular DNA, Recombinant - chemistry Drug Stability Humans Quality Control Recombinant Proteins - genetics Recombinant Proteins - standards
Online-Zugang:	Volltext
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