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Release Testing >> Identity Testing >> GMP (Sanger) Sequencing

GMP (Sanger) Sequencing

It is commonly used for confirmation of the sequence and integrity of a gene or plasmid, prior to sub cloning or transfection into a cell line or viral vector. It is also the method of choice for verification that a gene of interest has been successfully been introduced into a target cell, or that a genetically modified virus has the desired genetic composition.

 

Sequencing for Regulatory Submission, Identification and Confirmation

For regulatory submission of therapeutic proteins and vaccine production, DNA sequencing of the entire plasmid or viral vector is required. In addition, DNA sequencing can be used to confirm the identity and stability of (production) cell lines and for patent submissions.

 

Eurofins BioPharma Product Testing offers:

  • First in class service
  • Highest quality Sanger sequencing (Q15, Q20 or Q40 standards)
  • Complies to Good Manufacturing Practices (GMP)
  • Fully validated
  • 2-4 times sequencing coverage per strand (or adapted to your wishes)

 

Our full service includes:

  • Primer design and synthesis
  • Performance of all necessary sequencing reactions
  • Alignment of the sequences to a contig-sequence
  • Alignment of the contig-sequence to the supplied reference.

 

You will receive a QA approved and signed GMP compliant report together with analysis files per sample (pdf files) and (if desired) all raw sequence data (abi/scf/seq files).

Eurofins BioPharma Product Testing Netherlands also provides additional services like DNA extraction, DNA amplification (using (RT)PCR), DNA purification and a primer walking strategy.

 

Why choose Eurofins BioPharma Product Testing Netherlands

  • Complete outsourcing partner. Next to stability testing, Eurofins BioPharma Product Testing Netherlands can be your partner for chemical and microbial testing, GMP manufacturing and Import testing. For all our services, click here.
  • All services available internally. Eurofins BioPharma Product Testing Netherlands has several laboratories available to perform all the tests you require.
  • Specialized solutions. Some requirements go further than the current standards. Please contact us to discuss to possibilities in developing tailor-made solutions that meet your requirements.

Please contact us to discuss your GMP Sequencing and molecular biology needs.