FDA GLP Quality Primer Walking Overview

SeqWright’s FDA GLP Quality primer walking service provides contiguous double-stranded sequence information, with each strand sequenced twice for at least 4X sequencing coverage of the region of interest. Because both strands are sequenced at regulatory submission quality, we can guarantee a Phred quality score of Q=40 (basecall error approximately at 1:10000 nucleotides) for all bases assigned calls.

FDA GLP Primer Walking Service Features

Project and primer design.
ABI Prism™ 3730xl DNA sequencing.
Minimum 4X double strand coverage.
Data assembly & editing.
Consensus quality scoring (min. Q40).
LIMS sample tracking.
GLP-compliant data handling.
Final project reports reviewed and signed by the Quality Assurance Unit (QAU).

Regulatory Compliance Services

Sanger DNA Sequencing.
Shotgun Sequencing.
SNP/Biomarker Discovery.
Expression Analysis.
Genotyping.
QPCR.
- Real-Time, Absolute and Allelic Discrimination.
- Genetic Stability Testing.
Residual DNA Analysis.
Custom molecular biology.
cDNA sequencing including viral RNA Sequencing.

Contact a sales representative about our services.