Cytiva eBook - 10

PODCAST

Management of detection and quantification of host cell proteins (HCPs)
able to justify it and you will also be able to adjust your
purification strategy or your cell culture condition in
real time.

used an accurate workflow like a large gel format, 2D
DIBE, recent technologies, laser-based scanners, and
accurate 2D software.

For those who are not able to set up in-house, make
sure that the supplier has used the right workflow to
deliver you the most accurate data. For example, the
gel size used by the supplier can have an impact on
data quality.

Gareth Macdonald:
Joe, following on from the approach Anne-Sophie
outlined there, how could this method be extended?
What are the possibilities of the approach that
you're advocating?

Using a 7-cm gel you can only visualize a maximum of
around 300 spots, or 300 HCPs. But if the supplier were
to use a 24-cm gel they would be able to see more than
1000 spots (more than 1000 HCPs). Understanding all
those parameters will help you to follow your supplier
and to make sure that the data they will deliver to you
are the most accurate.

Joe Hirano:
We started by introducing 2D DIGE and 2D DIBE
technology for coverage assays a few years ago,
including optimized coverage analysis software.
So now, as far as the coverage assay is concerned,
we have the whole workflow solution.

Gareth Macdonald:
So it's key to keep control and to make sure all the
various steps are integrated. How does a drug company
go about ensuring that its HCP management approach
is fully integrated, whether it is done in-house or with
a supplier?
Anne-Sophie Brès:
Challenge your ELISA kit by performing a coverage
assay. Make sure your kit is detecting enough HCPs in
the low molecular range where the most immunogenic
HCPs are seated. Because it's not only a question about
limit of quantification, make sure that the antibodies in
your generic kit will detect those HCPs in this region.
And for your coverage assay, make sure that you have

10

| GENengnews.com

However, if we look at the entire HCP and other impurity
analysis methods for biologics process development
there is more room for improvement. Along with this
idea, we have recently launched a generic HCP ELISA
and coverage assay kit for CHO-cell lysate.
And we have been working on ELISAs and coverage
kits for other cell lines. We'd like to support our customers
by covering as much as possible with analytical
methods used in biologics process development. n

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Cytiva eBook

Table of Contents for the Digital Edition of Cytiva eBook

Contents
Cytiva eBook - 1
Cytiva eBook - 2
Cytiva eBook - 3
Cytiva eBook - Contents
Cytiva eBook - 5
Cytiva eBook - 6
Cytiva eBook - 7
Cytiva eBook - 8
Cytiva eBook - 9
Cytiva eBook - 10
Cytiva eBook - 11
Cytiva eBook - 12
Cytiva eBook - 13
Cytiva eBook - 14
Cytiva eBook - 15
Cytiva eBook - 16
Cytiva eBook - 17
Cytiva eBook - 18
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