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GMP-Compliant DNA 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 marketing clearance applications. No matter if European or FDA-level submissions are to be sought, 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
  • Guaranteed accuracy of final data at 2-fold coverage: 99.999 % per base
  • Guaranteed accuracy of final data at 4-fold coverage: 99.99999999 % per base
  • Quality assurance statements (ISO/IEC 17025; STS 429 and GMP Swissmedic 16-0427)

 

Accurate
  • In-house controlled synthesis of primers
 
Professional Project Handling
  • Each project is guided by a designated study director
  • Evaluation of each chromatogram
  • Sequence verification with a known reference sequence including mutation detection or de novo sequencing
 
 
 
Reporting & Documentation
  • Assembly of sequence data and detailed description of the sequencing process
  • Extended GMP project reporting
  • Archiving of data for 10 years (longer times available on request)
 
Experience
  • Experienced with the management of GMP projects for international major pharmaceutical companies
 

Useful Additional Services

  • GLP-like Sanger DNA sequencing
  • GMP/GLP-like NGS sequencing
  • GMP/GLP-like qPCR services
 

Services

 

Our cGMP DNA Sanger sequencing services are designed for identity and stability tests of cGMP biologics, to analyze pre-clinical and clinical trial samples, and to validate DNA-based diagnostic tests and devices for marketing clearance applications.

 

  • GMP Biologics Lot Release: Sanger sequencing is applied as QC for final lot release of plasmid DNA and viral products used for the manufacturing of biologics
  • DNA/RNA identity and stability studies: Sanger sequencing is used for identity and stability tests of cell banks, plasmids, viruses and vaccines
  • Genetic testing for pre-clinical and clinical studies: 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

How to Order

 

When you collaborate 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 to get an attractive quote!