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GMP-Compliant DNA Sanger Sequencing

 
 
Established cGMP Sanger sequencing service for release testing of regulated biological drugs as well as for validation of DNA-based diagnostic tests/devices for market clearance applications. Whether you wish to make a European or FDA-level submissions, Microsynth’s quality system has been set up to meet the most stringent quality requirements from regulatory authorities worldwide.
 

Features and Benefits

High Quality
  • 2-fold or 4-fold coverage sequencing service available
  • All analyses performed according to GMP requirements
  • Guaranteed accuracy of final data >99.999% per base
  • Quality assurance statement (ISO/IEC 17025 (STS 429) and GMP Swissmedic 20-0362)
Accurate
  • Fast turnover time due to in-house synthesis of primers
  • Plasmid isolations under GMP conditions for GMP samples
Professional Project Handling
  • Each project is guided by a designated study director
  • Evaluation of each chromatogram
  • Sequence verification against a known reference sequence including mutation detection or de novo sequencing
Reporting & Documentation
  • Assembly of sequence data and detailed sequencing strategy reporting
  • Extended GMP project reporting
  • Archiving of samples and data for 10 years (longer times available on request)
Experience
  • Experienced with the management of GMP projects for international major pharmaceutical companies

Applications

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 preclinical 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 preclinical 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.

How to Order

When you work with Microsynth, we share our experience and knowledge, respond to your needs in a timely manner and give you undivided attention. Contact our application specialists to discuss your next GMP DNA sequencing project in detail and receive an attractive quote!

 

Procedure to use our Primer Walking Service - GMP Service for sequencing:
  • Enter our webshop
  • Follow the further instructions