GLP-Compliant Confirmatory Sequencing

Biologics testing solutions ensure reproducible results across the preclinical to production pipeline.  Confirmatory sequencing under Good Laboratory Practice (GLP) guidelines provides confirmation of your biologic using Sanger sequencing to support FDA- and EPA- submissions. The right sequence means the right product!


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GLP-Compliant Sequencing Promo: 25% Off!

Get 25% off your first order of GLP-compliant sequencing for a limited time

SANGER SEQUENCING FOR BIOLOGICS TESTING

GENEWIZ can characterize samples for identity and stability from preclinical stages through the manufacturing pipeline. We utilize validated methods according to ICH Q2 guidelines to support analysis of your monoclonal antibody therapeutics, immunotherapeutics, viral vectors, vaccines, and agricultural products.

Simply provide your master cell bank (MCB), working cell bank (WCB), viral particles, viral vector, master virus stock (MVS), gDNA, mRNA, plasmids or PCR products.  GENEWIZ will design, develop, and optimize assays to verify identity and stability. Our experienced scientists and Quality Assurance Unit ensure that your samples are processed and results reported according to applicable regulatory standards to support IND, NDA, ANDA and BLA applications.

APPLICATIONS

Monoclonal Antibody Therapy

Heavy chain and light chain sequencing of MCB and WCB or viral vector confirmation

Vaccine Manufacturing

Characterization of MVS

Agricultural Products

Plant strain characterization

Gene Therapy 

Plasmid confirmation

Immunotherapy

Characterization of mRNA

Features & Benefits

Complete Solution: Nucleic Acid Extraction to Sanger Sequencing 

  • Nucleic acid extraction
  • Assay development/optimization
  • Complete sequencing of region of interest
  • Detailed final report; includes a description of the methods, list of SOPs, raw data, and detailed results

State-of-the-Art, Dedicated GLP Laboratories 

  • FDA and EPA GLP-compliant, reliable services
  • Controlled facility, sample tracking, personnel, process, and documents
  • Special handling for sensitive assays

Established Quality Management System 

  • Quality Assurance Unit oversight
  • GENEWIZ is available for audits

Outsource to the Industry Leader in Sanger Sequencing  

  • Developed and documented processes
  • Qualified instruments
  • Trained personnel
  • Dedicated, state-of-the-art regulatory laboratory
  • Thorough quality assurance program saves you time, reagents, paperwork

Proprietary Protocols 

  • Complete sequencing, even in regions with high-GC content
  • ≥4x double-strand coverage
  • TA Cloning, as needed

Superior Support 

  • Dedicated Study Director ensures a single point of contact
  • Expert technical support, and consistent, transparent communication

Sequence Confirmation Process


  • Assay Design



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  • Sample
    Processing


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  • Data Analysis & Reporting


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Primers and conditions are optimized to the target region(s) of interest. Study Protocol and SOPs are utilized in compliance with GLP regulations.
Sample preparation, amplification, and sequencing of target region(s). GENEWIZ network of quality oversight ensures compliance with GLP regulations.
Data quality review and detailed Study Report outlining methods used, results, compliance statement, and quality oversight inspection dates, results in Quality Assurance of each Study according to GLP regulations.

Deliverables

GENEWIZ provides both electronic and hard-bound reports for easy incorporation into regulatory submission files.



Description of all materials and procedures
Contig assemblies and graphic contig overview
Consensus sequences
Raw sequence data with accompanying quality scores
Detailed mutation report, where applicable
Certificate of Analysis (COA), where applicable
GLP Compliance Statement signed by Study Director or Principal Investigator
QAU Statement with inspection dates

GLP-COMPLIANT STANDALONE SANGER SEQUENCING

Standalone Sanger sequencing services are also available at the GLP-compliant level for integration into client analysis programs. 

 

 

 

Medical Device Validation and Clinical Sample Processing (510K and PMA)

Validation of Medical Device Assays coupled with GLP-compliant Sanger sequencing of clinical samples to support medical device applications are also available.

 

For more information, please email regulatory@genewiz.com.

 


How to Order

*Samples must arrive at the GENEWIZ New Jersey Laboratory before 10:00 am EST to qualify for Same Day service. Note that direct-sequencing templates are not available for our Same Day service.

Email | Phone (1-877-GENEWIZ (436-3949), Ext. 3350)