Purity
You may think your monoclonal antibody is as pure as it's going to
get. Or is it? The ProteomeLab PA 800 Protein Characterization System
can help determine the presence of impurities present in either your
end-product or in the process you're using to reach that point.
Visualization of impurities can help track changes in molecular
stability as well as those which may be present in manufacturing
conditions. |
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Capillary electrophoresis (CE) technology offers you an
alternative method to SDS-PAGE analysis for characterization of
antibodies. Sensitivity similar to that of coomassie blue stained gels
can be obtained using UV detection and similar to that of silver stained
gels can be obtained using LIF detection. The highly resolving nature of
CE also allows you to reveal protein species otherwise hidden using
conventional techniques. |
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The IgG purity and heterogeneity chemistry, is able to
resolve IgG isoforms that may be present due to degradation. With
non-reduced IgG, the assay will resolve intact IgG from various isoforms
including non-glycosylated IgG, 2 heavy chains and 1 light chain, 2
heavy chains, 1 heavy chain, and single light chains. With reduced IgG,
the assay will resolve the IgG heavy chain, light chain, and non-glycosylated
heavy chain. Additionally, any lower molecular weight impurities that
fall between the heavy and light chains, and higher molecular weight
impurities, larger than the intact heavy chain, can be resolved. |
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Impurities as a result of manufacturing processes and
product modification can result in altered efficacy as well as risk to
patient safety. Resolution between reduced antibody species and either
low or high molecular weight impurities can be achieved.
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Heterogeneity
Post translational modification of protein can be a desired
characteristic but sometimes is an alarming one. Antibody modification
may result in product heterogeneity and thus contamination of
end-product. The ProteomeLab PA 800 Protein Characterization System
allows for the analysis of heterogeneity effects on complete protein
molecules and lets you characterize the microheterogeneity due to
glycosylation. |
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Even seemingly pure antibody preparations may exhibit
heterogeneity. Resolving this can help determine the presence of any
differentially modified antibody species. |
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Glycosylation is an important post-translational
modification providing stability, adhesion, and recognition properties
to a given antibody. Differences in antibody glycosylation can alter
their function and thus their efficacy. N-linked oligosaccharides
obtained from PNGase F-catalyzed antibody hydrolysis can be labeled with
APTS and analyzed using LIF |
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By determining differences in the isoelectric points of
different antibodies, heterogeneity among lots as well as identity of
species in those lots can be verified. Automated separation based on
differences protein pI can easily show charge heterogeneity between two
lots of antibody |
Identification
Identification is important for complete molecular characterization.
The ProteomeLab Protein Characterization System can be interfaced
directly to mass spectrometry so online mass analysis can be performed. |
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Mass spectrometry can be an important component of the
protein identification process. The ProteomeLab PA 800 Protein
Characterization System is readily adaptable to MS systems so that
protein characterization can be followed by online mass spectrometry to
determine peptide mass-to-charge properties. |
| Compliance and Support |
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Training is an important part of efficient system
operation. Beckman Coulter's qualified instructors will take new
ProteomeLab PA 800 operators through a thorough and documented training
process. If required, a documented maintenance and calibration course is
available. |
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Beckman Coulter provides the tools to help you comply
with regulations such as GLP and CGMP. IQ (InstallationQualification)
and OQ (Operation Qualification) services are available for
qualification of the ProteomeLab PA 800. |
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Our
eLabNotebook an on-line application resource that helps you solve a
wide variety of important issues quickly and effectively. And our highly
trained field service technicians are on call and on target in helping
you get the most out of your Beckman Coulter products. |
