Development and Manufacture of a Cell Culture Process for a Phase 1 Biopharmaceutical Product /

Biopharmaceutical products, which make up a growing class of drug products, are manufactured through a series of bioprocessing operations. Using a hypothetical biopharmaceutical product as a model, this case study covers basic technical concepts in upstream bioprocess operations as well as the regul...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Herz, Lori (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, N.Y. : McGraw-Hill Education, 2020.
Colección:McGraw-Hill's AccessEngineering.
Temas:
Pharmaceutical biotechnology.
Drug development.
Biopharmaceutics.
Electronic books.
Acceso en línea:Texto completo

MARC

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040 |a IN-ChSCO  |b eng  |e rda 
041 0 |a eng 
050 4 |a RS380 
082 0 4 |a 338.476151  |b 223 
100 1 |a Herz, Lori,  |e author. 
245 1 0 |a Development and Manufacture of a Cell Culture Process for a Phase 1 Biopharmaceutical Product /  |c Lori Herz. 
264 1 |a New York, N.Y. :   |b McGraw-Hill Education,   |c 2020. 
264 4 |c ?2020. 
300 |a 1 online resource :  |b illustrations. 
336 |a text  |2 rdacontent 
337 |a computer  |2 rdamedia 
338 |a online resource  |2 rdacarrier 
490 1 |a McGraw-Hill's AccessEngineering 
504 |a Includes bibliographical references and index. 
520 3 |a Biopharmaceutical products, which make up a growing class of drug products, are manufactured through a series of bioprocessing operations. Using a hypothetical biopharmaceutical product as a model, this case study covers basic technical concepts in upstream bioprocess operations as well as the regulatory requirements for Phase 1 clinical trials, Investigational New Drug applications, and Current Good Manufacturing Practices. 
530 |a Also issued in print and PDF version. 
533 |a Electronic reproduction.   |b New York, N.Y. :   |c McGraw Hill,   |d 2020.   |n Mode of access: World Wide Web.   |n System requirements: Web browser.   |n Access may be restricted to users at subscribing institutions. 
538 |a Mode of access: Internet via World Wide Web. 
546 |a In English. 
588 |a Description based on online resource, viewed on April 01, 2020 
650 0 |a Pharmaceutical biotechnology. 
650 0 |a Drug development. 
650 0 |a Biopharmaceutics. 
655 0 |a Electronic books. 
830 0 |a McGraw-Hill's AccessEngineering. 
856 4 0 |u https://accessengineeringlibrary.uam.elogim.com/content/case-study/CS0003_Herz_Case_Study_Cell_Culture_text_figures  |z Texto completo 

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