GLP/GMP Regulatory-Compliant DNA Sequencing

Microsynth provides Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulatory-compliant services for European Commission- as well as FDA-level applications and submissions.

Our cGMP/GLP DNA sequencing services have been established to support our customers in the following areas:

  • 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
  • cGMP Biologics Lot Release: Sanger sequencing is applied as QC for final lot release of plasmid DNA and viral products used for biologics manufacturing

Main Service Features and Benefits:

  • You have the choice between 2-fold or 4-fold coverage
  • Each project is guided by a designated study director who oversees all the steps
  • Quality control of incoming DNA
  • Design of sequencing primers every 700 bases (2-fold coverage) or 300-400 bases (4-fold coverage), in-house synthesis of these primers
  • Complete double stranded sequencing of the region of interest with at least 2 or 4 fold coverage
  • Evaluation of each chromatogram. Only sequences with quality values >30 (base call accuracy higher than 99.9%) are used for the assembly
  • Assembly of sequence data
  • Sequence verification against a known reference sequence or de novo sequencing
  • Guaranteed accuracy of final data: 2-fold coverage (>99.999%),  4-fold coverage (>99.99999%)
  • Extended sequencing project documentation
  • Detailed sequencing strategy
  • Quality assurance statement (ISO/IEC 17025 (STS 429))
  • Documents signed by the study director
  • Archiving of samples and 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 cGMP/GLP DNA sequencing field or to request a quote, please contact our experts.

 

 

 

 







     



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