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.

We also offer the following services

Residual DNA
Genotyping
Forensic Testing,
Gene Expression
DNA sequencing

Quantitative PCR
Gene cloning and expression
DNA preparation
Contract research
ELISA and Western Blotting
Animal identity testing
Microarray technology
Human / Cell line identity testing

We are reliable, responsive and cost effective. Contact 0191 516 6500 or email sales@geneblitz.com for a discussion of your requirements.

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