Linked Life Data

19731253

Source:http://linkedlifedata.com/resource/pubmed/id/19731253

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2009-12-28
pubmed:abstractText
Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
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
285-95
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications.
pubmed:affiliation
CDER, FDA, Silver Spring, Maryland, USA.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't