GMP-Compliant Sequencing

Seqlab-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:

  • 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 GMP DNA sequencing field or to request a quote, please contact our experts.

Seqlab - Sequence Laboratories Göttingen GmbH
Hannah-Vogt-Str. 1
37085 Göttingen

Postfach 3343
37023 Göttingen

Telefon 0551-370 00 10
Telefax 0551-370 00 12

E-Mail info@seqlab.de

© 2013 SEQLAB Sequence Laboratories Göttingen GmbH,
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