GMP-Compliant DNA Sequencing

Microsynth provides Good Manufacturing Practice (GMP) regulatory-compliant services1 for European Commission- as well as FDA-level applications and submissions. Our GMP DNA sequencing services have been established to support our customers in the following areas:
  • GMP Biologics Lot Release: Sanger sequencing is applied as QC for final lot release of plasmid DNA and viral products used for biologics manufacturing
  • DNA/RNA identity and stability studies: Sanger sequencing is used for identity and stability tests of various cell banks, plasmids, viruses and vaccines
  • Genetic testing for pre-clinical and clinical testing: Sanger sequencing is utilized as “Gold Standard” method to analyze clinical trial samples(e.g. for SNP detection) or to validate assays to be used in pre-clinical or clinical trials
  • Validation of in vitro DNA-based diagnostic assays: Sanger sequencing is used as “Gold Standard” method to validate nucleic acid based diagnostic assays or devices for regulatory clearance

Main Service Features and Benefits:
  • 2-fold or 4-fold coverage sequencing service available.
  • Analysis performed according to GMP requirements
  • Extended GMP project reporting
  • Each project is guided by a designated study director
  • Fast turnover time due to in-house synthesis of primers
  • Guaranteed accuracy of final data >99.999%
  • Sequence verification against a known reference sequence including mutation detection or de novo sequencing
  • Evaluation of each chromatogram
  • Assembly of sequence data and detailed sequencing strategy reporting
  • Quality assurance statement (ISO/IEC 17025 (STS 429) and GMP Swissmedic 14-934)
  • Archiving of data for 10 years (longer times available on request)

Request for Technical, Pricing and Ordering Information

To obtain more information about Microsynth’s service in the GMP DNA sequencing field or to request a quote, please contact our experts.

1 The certificate of GMP compliance has been granted by Swissmedic and is restricted to DNA sequencing by the Sanger method.

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Related Downloads
GMP Certificate.pdf

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