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Application of process analytical te...

Nalbandyan, Lilit.

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Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes./
Author:	Nalbandyan, Lilit.
Description:	89 p.
Notes:	Source: Masters Abstracts International, Volume: 53-01.
Contained By:	Masters Abstracts International53-01(E).
Subject:	Engineering, General. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1525504
ISBN:	9781321029277

Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes.
Nalbandyan, Lilit.

Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes. - 89 p.

Source: Masters Abstracts International, Volume: 53-01.

Thesis (M.S.)--California State University, Dominguez Hills, 2014.

The Process Analytical Technology (PAT) guidance is a scientific and regulatory framework issued in 2004 by the U.S. Food and Drug Administration for innovating and improving the pharmaceutical industry.

ISBN: 9781321029277Subjects--Topical Terms:

1020744
Engineering, General.

Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes.
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020 $a 9781321029277
035 $a (MiAaPQ)AAI1525504
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100 1 $a Nalbandyan, Lilit. $3 2101155
245 1 0 $a Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes.
300 $a 89 p.
500 $a Source: Masters Abstracts International, Volume: 53-01.
500 $a Adviser: Pam Dunahay.
502 $a Thesis (M.S.)--California State University, Dominguez Hills, 2014.
520 $a The Process Analytical Technology (PAT) guidance is a scientific and regulatory framework issued in 2004 by the U.S. Food and Drug Administration for innovating and improving the pharmaceutical industry.
520 $a The implementation of PAT in the plasma-derived protein industry has been marked with delays due to regulatory and process complexities. This thesis demonstrates that the existing regulatory environment and technological advancements provide fertile grounds for the adoption of PAT in the plasma-derived industry. The paper presents regulatory guidance, which aids in resolving regulatory hurdles and promotes the adoption of PAT to harness benefits from the elimination of costly and time-consuming sample testing, revalidations, and submission reviews. This thesis shows that the technological advancements and tools developed for the biotechnology industry can serve as a basis for the implementation of PAT in the plasma-derived industry by overcoming process complexities, controlling variability, improving process understanding and control, increasing innovation, and reducing process waste.
590 $a School code: 0582.
650 4 $a Engineering, General. $3 1020744
650 4 $a Health Sciences, Pharmacy. $3 1017737
650 4 $a Statistics. $3 517247
690 $a 0537
690 $a 0572
690 $a 0463
710 2 $a California State University, Dominguez Hills. $3 1017917
773 0 $t Masters Abstracts International $g 53-01(E).
790 $a 0582
791 $a M.S.
792 $a 2014
793 $a English
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1525504