GLP-Compliant Confirmatory Sequencing
The Gold Standard For Non-Clinical Safety Studies.
Sequence confirmation is critical in preclinical and production pipelines, especially if you plan for a FDA and/or EPA submission. GLP-compliant sequencing offers an added layer of documentation, quality control, and process control to support regulated and non-regulated industries confirm their sequences with confidence. It combines Sanger sequencing, which is already the gold standard for sequence confirmation with a 99.9999% accuracy rate, with the quality standards of a preclinical lab. Our GLP-compliant sequencing services include:
- Quality control of incoming DNA
- Design and synthesis of required primers
- Double strand sequence confirmation (2fold or 4fold coverage) by primer walking or by PCR amplification and sequencing
- Guaranteed accuracy of final data: 2fold coverage: > 99.999% and 4fold coverage: > 99.99999%
- Nucleic acid extraction, reverse transcriptase or DNA cloning are available on demand.
- Established quality management system that is compliant with GLP guidelines set by the FDA.
- Established leader in Sanger sequencing with experience, equipment, and expertise in this field.
- Dedicated Study Director and resources.
- Outstanding support throughout the process.
- Complete report the covers every aspect of the process, reagents, methods, and results.
- Customized study plan and study report according to customers' requirements
- Detail description of utilized materials and procedures
- Alignment of sequences based on Q30 quality clipped reads (accuracy 99.9%) and coverage overview
- Quality check and report for the generated consensus sequence
- Raw sequence data with quality assignment
- Verification of a reference sequence and variation report if applicable
- Comprehensive information about detected mutations (mutation report if applicable)
- Signed quality assurance (QA) statement
- Storage of test items for one year
- Archiving study data for 15 years
To ensure the quality of our GLP certified sequencing service, we are routinely assessed by first and second external auditors. Additionally we perform regularly facility and process audits.