Back to top

GMP-Compliant Sanger Sequencing for Regulated Applications

GMP-Compliant Sanger Sequencing
 
 
Regulatory-grade DNA sequencing for biologics release testing, clinical studies and diagnostic validation. Microsynth delivers fully documented, GMP-compliant sequencing with dedicated project management and long-term data traceability. Designed to meet the stringent requirements of FDA and European regulatory authorities.
 

Why Choose GMP Sanger Sequencing?

  • Fully GMP-compliant workflows – all analyses performed according to regulatory requirements
  • Highest data accuracy – >99.999% per base with optional multi-fold coverage
  • Dedicated project management – each project guided by an assigned study director
  • Regulatory-ready documentation – detailed reports supporting submissions and audits
  • Long-term data integrity – secure archiving of samples and data for ≥10 years

Applications

  • GMP biologics lot release testing
  • DNA/RNA identity and stability studies
  • Genetic testing for preclinical and clinical trials
  • Validation of DNA-based diagnostic assays and devices
  • Regulatory submissions (FDA / EMA)

What is GMP-Compliant Sequencing?

GMP Sanger sequencing is a regulatory-compliant analytical method used for quality control, validation and release testing of nucleic acid-based products.

Microsynth performs all sequencing activities under GMP conditions, ensuring traceability, reproducibility and compliance with international regulatory standards.

Project Workflow

  1. Definition of project scope and regulatory requirements
  2. Assignment of a dedicated study director
  3. Sample processing under GMP conditions
  4. Sequencing and chromatogram evaluation
  5. Sequence verification against reference or de novo analysis
  6. Generation of detailed GMP-compliant reports
  7. Long-term archiving of samples and data

Quality & Compliance

  • GMP-certified sequencing processes (Swissmedic authorization)
  • Full traceability and audit readiness
  • Controlled documentation and validation procedures

Output & Documentation

  • Chromatogram evaluation and sequence data
  • Verified sequence results (reference-based or de novo)
  • Detailed sequencing strategy documentation
  • Extended GMP project reports
  • Audit-ready documentation packages

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!