Linked Life Data

9561769

Source:http://linkedlifedata.com/resource/pubmed/id/9561769

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
1998-5-12
pubmed:abstractText
A capillary isoelectric focusing (cIEF) method has been developed for the purpose of determining the identity and charge distribution of mouse/human chimeric antibody to human CD20 antigen (C2B8). The assay was validated in accordance with ICH guidelines in order to demonstrate that it is suitable for its intended purpose and so that it may be performed as a lot release test for bulk and final product. As a result of the validation process the assay was found to be linear over the concentration range of 2-356 micrograms ml-1 with recovery of 125I-labeled C2B8 at the target sample concentration of 125 micrograms ml-1 equal to 99%. The repeatability and intermediate precision relative standard deviations of the four major peaks for migration time, peak area, and peak area percent ranged from 0.9-4.4%. The specificity of the assay was demonstrated by baseline resolution of the C2B8 main peak from product excipients, and other Genentech monoclonal antibodies. The results of this validation demonstrate that the cIEF assay for the determination of identity and charge distribution of C2B8 is accurate, precise, linear, and highly specific. The assay is rapid and suitably rugged.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0021-9673
pubmed:author
pubmed:issnType
Print
pubmed:day
27
pubmed:volume
800
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
355-67
pubmed:dateRevised
2009-1-15
pubmed:meshHeading
pubmed:year
1998
pubmed:articleTitle
Validation of a capillary isoelectric focusing method for the recombinant monoclonal antibody C2B8.
pubmed:affiliation
Department of Quality Control Clinical Development, Genentech Inc., South San Francisco, CA 94080, USA.
pubmed:publicationType
Journal Article, Comparative Study