GMP/GLP nextgen sequencing

Avance Biosciences is offering GMP/GLP next generation DNA Sequencing services using Illumina’s state-of-art MiSeq and HiSeq systems. Our GMP/GLP next generation DNA sequencing services are established to support drug development and manufacturing, as well as the development and validation of DNA/RNA-based diagnostic tests.

Applications

Application Description
Bacteria Genome Sequencing Genetically modified bacteria found various applications in human disease treatment and in plant pest control.  NGS full genome sequencing may be required by regulatory agencies to evaluate the identity, purity, and genetic stability of the bacteria.
Viral Genome Sequencing Recombinant oncolytic viruses have been increasingly employed for novel targeted cancer treatment.  Using NGS technology, Avance Biosciences can help our clients to characterize their viral products to verify that the viruses are free of undesirable mutations or reversion to wild-type viruses.
Amplicon Sequencing for Gene Editing Human cells that modified using CRISPR/cas9 and other genetic editing tools are a promising tool for personalized cancer treatment. Using custom designed NGS amplicon sequencing assays, Avance Biosciences can help out clients to evaluate the gene editing profiles of the modified cells and to verify their genetic stability in animal safety studies and in clinical trials.
Insertion Site Characterization Avance Biosciences has developed a proprietary NGS sequencing and analysis pipeline to elucidate the DNA sequences of the inserted genes and their immediate down-stream and up-stream host genome sequences.
Adventitious Agents Testing Cell lines and other raw materials used for GMP biologics manufacturing must be tested vigorously to ensure that they are from viral or bacterial contamination.  NGS provides a non-targeted and sensitive analytical tool for adventitious agents testing.
Cross-Validation of Diagnostic Assays/Devices NGS is becoming the new “Gold Standard” of DNA sequencing for validating PCR based assays that target on minor allelic variants. 
Genetic Testing for Clinical Trials Next-generation sequencing enables sensitive, accurate, thorough, and cost-effective detection of mutations of low-abandance in multiple genes associated with cancers. Both GMP and GLP compliant MiSeq sequencing are available.

Compliance

Our quality system is well designed and maintained to meet the most stringent requirements from regulatory authorities worldwide.  This system is well tested in many on-site client quality audits and is highly accommodated by our customers.

  • cGMP compliance per FDA 21 CFR Part 210/211
  • GLP compliance per FDA 21 CFR Part 58
  • 21 CFR Part 11 compliance
  • Methods/assays validated per ICH guidelines
  • Regularly equipment maintenance and calibrations.
  • Routine internal quality audits and in-process audits
  • Documented change control and review program
  • Incident report, OOS, and CAPA program
  • Vendor assessment program and raw material quarantine and release program
  • Optimized laboratory design and rigorous cross-contamination prevention measures
  • Ongoing employee training and proficiency test program
  • Complete documentation of laboratory procedures
  • Project archive and storage procedures

Experience

Our experienced technical and quality staff have worked together for more than a decade offering GLP/GMP level genomic services for regulatory submissions.

  • Experienced with GLP/GMP project management
  • Experienced with international clients
  • Experience with all major pharmaceutical companies
  • Strong technology and assay transfer capability
  • Assay and project reports readily accepted by regulatory authorities
  • Facility frequently audited by clients

Quote Request

Send us an email describing your project, and we will send you a quotation in 24 hours.



Contact our customer service to discuss your needs for GMP or GLP next generation DNA sequencing. Our experienced technical and quality specialists can assist you in your assay design and validation.