Confidence Through Compliance, Collaboration, and Communication
Highly Reliable, Effortless Collaboration for FDA and EPA Applications
Good Laboratory Practice (GLP) Services
Good Laboratory Practice (GLP) services from GENEWIZ are designed to be compliant with US FDA (21 CFR Part 58) and US EPA (40 CFR Part 160) regulations to support pre-marketing authorizations. Our commitment to providing reliable, cost-effective services and high-quality results remain paramount in our GLP-compliant services in addition to following GCP and GMP guidelines (as applicable).
We treat all customer information, study-related data, and intellectual property, with the same degree of care and security that we do for our own. This allows our customers at both top-tier pharmaceutical companies and biotechnology start-ups the flexibility to utilize our regulatory services while trusting in our commitment to quality and communication.
GLP-Compliant Sequencing of Full AAV Plasmid, Vectors, and Packaged Products
Learn MoreGood Laboratory Practices Services
GLP Confirmatory Sanger Sequencing
Confirm your biologics using Sanger sequencing to support FDA- and EPA- submissions.
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.
GLP AAV-ITR Sequencing
GENEWIZ AAV-ITR Sanger sequencing protocol sequences through difficult inverted terminal repeat (ITR) regions of adeno-associated virus (AAV), prevents abrupt reduction in the sequencing signal at the start of the ITR hairpin, and reads through the full length of the ITR region.
GLP SNP/Mutation Analysis
GENEWIZ SNP/Mutation Analysis is designed to validate diagnostic assays with confidence and detect genetic mutations accurately, empowering you to achieve clinical success.
GENEWIZ can sequence and analyze your clinical trial samples or confirm your diagnostic assay results according to FDA and EPA GLP standards. Simply provide SNP IDs, genes, or sequences of interest and we can design, develop, and optimize your assays.
GLP Plasmid Preparation
Performed in our state-of-the-art GLP facility, GENEWIZ’s endotoxin-free DNA preparation services, including animal-free plasmid preparations, are FDA and EPA GLP compliant to accelerate pre-clinical development of therapeutics for clients in biotechnology, pharmaceuticals, and other industries.
Our plasmid DNA can be used for the development of various biologics, including, but not limited to, monoclonal antibodies, cell and gene therapies, and viral vaccines. In addition, our GLP DNA products also act as internal controls for biomarker assays and kits.
GLP Nucleic Acid Extraction
GENEWIZ provides nucleic acid extraction as part of complete projects and as a standalone service. Simply provide us with your sample and we do the rest— delivering you a high quality extracted product or characterization of the extracted material in a downstream application on-site.
Features & Benefits
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Scalable, customizable, GLP-compliant services with client-approved protocols offers a complete solution to support your regulatory submissions.
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State-of-the-art, dedicated GLP laboratories meet FDA and EPA guidelines to enable controlled samples, personnel, instruments, processes, and documents.
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Stringent quality control based on your project needs with multiple reviews and established Standard Operating Procedures (SOP) to generate consistent results.
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Established Quality Management System with oversight from independent Quality Assurance Unit guarantees data adheres to FDA and EPA regulations. GENEWIZ is available for audits.
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Dedicated Study Director ensures a single point of contact, expert technical support, and consistent, transparent communication throughout the project.
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Customized study reports include methods used, raw data, results, details on Quality Assurance oversight and inspections, GLP compliance statement, Certificate of Analysis (COA), and more where applicable.
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.
Deliverables
GENEWIZ provides both electronic and hard-bound reports for easy incorporation into regulatory submission files. Components of customized final reports and data packages from GENEWIZ may include, but are not limited to:
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Description of all materials and procedures
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Contig assemblies and graphic contig overview
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Consensus sequences
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Raw sequence data with accompanying quality scores
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Detailed mutation report, where applicable
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Certificate of Analysis (COA), where applicable
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GLP Compliance Statement signed by Study Director
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QAU Statement with inspection dates