cGMP DNA Sequencing

As more and more recombinant protein therapeutics come to the market, there is an increasing need for GLP/cGMP sequencing as part of genetic stability panels. These quality control cell banks are used in the production of these biological products. DNAVision SA is the first laboratory to be ISO17025 accredited for DNA sequencing.

PCR or RT-PCR sequencing
Primer walking for plasmids or large inserts sequencing

For each project, DNAVision SA develops a Study Protocol with details of the proposed sequencing strategy. All bases are resolved, even in regions of high GC content or difficult secondary structure. Benefits of DNAVision SA GLP/cGMP sequencing service include:

All work conducted under requirements of GLP/cGMP
ISO17025 accredited laboratory
4-fold coverage of every nucleotide
Report suitable for inclusion in regulatory agency submissions

Brochure: DNA Sequencing at DNAVision

Sample Requirements

Clients submit purified plasmid DNA, RNA, or PCR products, frozen tissues, purified viral particles, crude cell lysates, cells (bacterial, yeast, or mammalian) or blood.

Results

The final report includes a description of the overall project design, original electropherograms or raw trace files, graphical overviews of contig assemblies, consensus data text files, and a quality assurance statement. All project data is archived at DNAVision SA.