GMP/GLP DNA sequencing

Avance Biosciences’  cGMP/GLP DNA Sequencing services are performed in compliance with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (GMP) promulgated by US FDA, OECD, European Commission (EC), and Japanese agency, as applicable to the service provided.

Applications

Our cGMP/GLP DNA sequencing services are established to support the identity and safety test of cGMP biologics, the analysis of preclinical and clinical trial samples, and the validation of DNA-based tests and devices for Premarket Approval (PMA) or 510K clearances.
Application Description
Cell Bank Characterization High quality (4-fold coverage) double stranded Sanger sequencing is used for identity and stability tests of Master Cell Bank (MCB), Working Cell Bank (WCB), and End of Production Cells (EOPC). Plasmid DNA for non-integrated cell banks and cDNA or genomic DNA for integrated cell banks are typically sequenced.
Biologics Lot Release High quality (4-fold coverage) double stranded Sanger sequencing is used to QC GMP plasmid DNA  and viral products for final lot release.
Genetic Testing for Pre-clinical and Clinical Trials Sanger sequencing is a “Gold Standard” method and is used to sequencing clinical trial samples (such as for SNP detection) or to validating assays to be used in pre-clinical and clinical trials.
Validation of in vitro DNA-based Diagnostic Devices Sanger sequencing is utilized as the “Gold Standard” to validate nucleic acid based diagnostic tools/devices for PMA or 510K clearances.

Compliance

Our quality system is well designed and maintained to meet the most stringent requirements from regulatory authorities worldwide.  This system is well tested in many on-site client quality audits and is highly accommodated by our customers.

  • cGMP compliance per FDA 21 CFR Part 210/211
  • GLP compliance per FDA 21 CFR Part 58
  • 21 CFR Part 11 compliance
  • Methods/assays validated per ICH guidelines
  • Regularly equipment maintenance and calibrations.
  • Routine internal quality audits and in-process audits
  • Documented change control and review program
  • Incident report, OOS, and CAPA program
  • Vendor assessment program and raw material quarantine and release program
  • Optimized laboratory design and rigorous cross-contamination prevention measures
  • Ongoing employee training and proficiency test program
  • Complete documentation of laboratory procedures
  • Project archive and storage procedures

Experience

Our experienced technical and quality staff have worked together for more than a decade offering GLP/GMP level genomic services for regulatory submissions.

  • Experienced with GLP/GMP project management
  • Experienced with international clients
  • Experience with all major pharmaceutical companies
  • Strong technology and assay transfer capability
  • Assay and project reports readily accepted by regulatory authorities
  • Facility frequently audited by clients

When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss your next GLP/GMP DNA sequencing project!

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