Residual DNA analysis
Designed especially for companies in the biomanufacturing
sector we offer testing for residual DNA during the production of
bio pharmaceuticals
We detect and quantify residual host cell DNA in
validated assays for Echerichia Coli, Saccharomyces cerevisiae,
chinese hamster ovary cells, murine hybridoma and murine myeloma
expression systems.
Other assays may be developed to serve the expression
system of your choice, such as Pichia pastoris and N.tabacum.
Our service offers:
- Assay design, including primer
design and synthesis
- Assay optimisation (an exonuclease
Q-PCR assay)
- Standard assay performance
- Assay verification and validation
in accordance with ICH guidelines (discussed with you in detail)
- Data analysis
- Report writing – delivered
in the format you require.
- All of our services are performed
according to BS EN ISO9001:2000.
We are reliable, responsive
and cost effective. Please
contact us now for discussion of your needs.
*PCR assays are performed pursuant to a license
agreement with F. Hoffman-La Roche Ltd.
You may also like to consider our other
services dedicated to the biomanufacturing sector.
- Vector construction
We offer a cloning and plasmid preparation service using commercially
available vectors. We can also work with you to design and generate
bespoke vectors, where we use a variety of techniques such as
PCR-based site-directed mutagenesis.
- Cloning
The Geneblitz® service is able to clone the gene of interest
into the chosen vector using either commercially available or
bespoke vectors. We are able to advise on cloning strategies and
will work with you to develop the protocol most suited to your
needs. We have successfully completed many cloning projects involving
a variety of systems and employ state of the art techniques throughout.
- DNA sequencing
Confirmation of plasmid sequence at different stages of the
bio-manufacturing process is vital. When your chosen clone has
been made, we will prepare and archive the plasmid DNA and accurately
sequence it to 1X, 2X, or 3X coverage as required.
The Geneblitz®
sequencing team operates the LI-COR Global IR² DNA sequencing
system, which is perhaps the most accurate system available on
the market today. In addition to having your data sent to you
in a wide choice of formats such as SCF, FASTA and Genbank. We
also provide quality values for each base called, which is particularly
useful for regulatory purposes. If required, sequences can be
aligned and provided in annotated form, with a bio-informatics
service included.
- Gene Expression studies
We can perform gene/protein expression studies on your samples
of interest using a number of techniques, including quantitative
PCR*. You can then check for levels of gene expression at all
stages of the scale-up and fermentation processes.
We will help you with the initial assay
design and optimisation protocols and also work with you to validate
your assays, if required, in accordance with ICH guidelines.
Full written reports are provided as
part of our service along with supporting documentation according
to your specific project requirements. All work is performed to
BS EN ISO9001:2000.
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