Agencourt's facility and operations are run under Good Laboratory Practices (GLP), 21 CFR Part 58, as enforced by the Food and Drug Administration (FDA). Agencourt performs all FDA submission and pharmacogenomic sequencing services in a compliant laboratory environment that exceeds the standards for quality, reliability and consistency. Our clients have the assurance that the data generated to support their clinical trials is robust and will meet regulatory submission standards. Rigorous guidelines for quality assurance and control are followed throughout our operations. Agencourt's extensive validation procedures and comprehensive Quality Assurance (QA) program supports our success by repeatedly passing on-site client audits.

Agencourt is leading the new paradigm in FDA-Quality Sequencing by our use of automation and innovative laboratory information management. Agencourt ensures complete sample custody by tracing it from the time it leaves your door, until your data is delivered to you. Each operation is performed with the utmost attention to detail and automated to the greatest extent possible.

Agencourt's FDA-Submission Quality Sequencing Packages include extensive reporting and documentation, QA oversight and audits, dedicated laboratory notebooks, archiving of all data in our FDA repository, and Phrap 40 coverage to ensure complete accuracy. You will receive a Final Report, signed by our QA Manager, detailing all SOPs, materials, methods and results. Our Final Report is comprehensive and can be submitted as part of your FDA application.

Services Offered
Agencourt provides for FDA submission-quality packages including:

• Publication-quality sequencing for double strand coverage
  We will sequence your plasmids or PCR¹ products to a minimum of 4x coverage and Phrap 40 quality. We can also provide a Discrepancy Report which compares observed versus expected sequence, and any effects of insertions or deletions on amino acid sequence.

• Whole Genome Shotgun Sequencing for Viral Vector Sequencing
  We will perform either shotgun library construction or tiled PCR amplification and Primer Walking. Assembly and finishing is completed at 10 to 12x coverage to ensure accuracy.

Automated Pipeline
Laboratory operations are automated to the greatest extent possible, allowing for a high degree of process control and standardization. Our automation is integrated into an Oracle backbone, and the Agencourt proprietary LIMS. As your samples move through our automated pipeline, our LIMS captures every reagent lot, technician, and piece of equipment that touches your samples. In addition, the LIMS data is paralleled by a comprehensive manual documentation system.

Dedicated Study Director
Agencourt's FDA-Submission Quality Sequencing Projects are managed by a Study Director. Agencourt's Study Directors are experienced scientists who are in constant communication with you, to ensure up-to-the minute knowledge of your project. As your FDA sample travels throughout our automated pipeline, the Study Director uses various software tools to monitor read length, signal strength and quality scores.

Quality Assurance
FDA-Submission Quality Sequencing Projects are carefully monitored by our Quality Assurance team. The Quality Assurance team conducts Project Initiation Audits, In-Process Audits, and a Project Completion Audit, to ensure the integrity of your samples. The QA Manager then issues a Quality Statement in the Final Report.

Data Protection

Agencourt has a validated Supervisory Control and Data Acquisition (SCADA) system for environmental monitoring, as well as complete automation and IT redundancy, to ensure the protection of your data. All hard data is stored in a fire proof vault for archiving purposes and electronic records are backed up on DLT tape and stored off site in the unlikely event that disaster recovery is necessary.

To Place an Order or Receive Technical Assistance: In the U.S. and Canada call us at 800-361-7780. Outside the U.S. and Canada call us at 978-867-2603. Email us at webinfo@agencourt.com.

¹ The PCR process is covered by patents owned by Roche Molecular Systems, Inc., and F. Hoffman-La Roche, Ltd.