Linked Life Data

19731252

Source:http://linkedlifedata.com/resource/pubmed/id/19731252

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2009-12-28
pubmed:abstractText
Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real-time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution of the underlying concepts and applications in biopharmaceutical manufacturing. We also present a literature review of applications in the areas of upstream and downstream processing to illustrate how implementation of PAT can help realize advanced approaches to ensuring product quality in real time. In the second part, we will explore similar applications in the areas of drug product manufacturing, rapid microbiology, and chemometrics as well as evolution of PAT in biotech processing.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
1097-0290
pubmed:author
pubmed:copyrightInfo
2009 Wiley Periodicals, Inc.
pubmed:issnType
Electronic
pubmed:day
1
pubmed:volume
105
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
276-84
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications.
pubmed:affiliation
CDER, FDA, Silver Spring, Maryland, USA.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't