GLP-Compliant Confirmatory Sequencing
Confirm your biologic using Sanger sequencing to support FDA- and EPA- submissions using our Confirmatory sequencing that adheres to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) as applicable to our services, and Good Clinical Practice (GCP) guidelines. Biologics testing solutions ensure reproducible results across the preclinical to production pipeline. The right sequence means the right product!
SANGER SEQUENCING FOR BIOLOGICS TESTING
Azenta Life Sciences, formerly 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. Azenta 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 Cell Line Development
- Heavy chain and light chain sequencing of MCB and WCB
Agricultural Products
- Plant strain characterization
Vaccine Manufacturing
- Characterization of master viral stocks/seeds (MVS)
Gene Therapy
- Plasmid confirmation
- Viral vector confirmation (lentivirus or AAV plasmids)
- Confirmation of genomic integrations
Immunotherapy
- Characterization of mRNA
Medical Devices
- Orthogonal testing for in vitro diagnostic validations
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
- Follows GMP (as applicable to our services) and GCP guidelines
Established Quality Management System
- Quality Assurance Unit oversight
- Azenta 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
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Assay Design
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Sample
Processing
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Data Analysis & Reporting
3
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@azenta.com.
