GENEWIZ REGULATED SERVICES
GLP, and GCP compliant. CAP/CLIA accredited. World Class Analysis.
Preclinical and Clinical Services
Depend on GENEWIZTM Preclinical & Clinical Services from Azenta to support your preclinical and clinical regulatory submissions. Our state-of-the-art US Laboratory adheres to Good Manufacturing Practices (GMP), as applicable to our services, Good Clinical Practice (GCP) guidelines and is compliant with FDA and EPA Good Laboratory Practices (GLP) and accredited by the College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA).
We offer a complete solution to support all your clinical and regulatory needs. From sample collection and storage, through to sample processing, sequencing, analysis, and reporting. Operating with the highest-quality standards, our flexible services are customized to meet each customer’s unique specifications.
CLIA AND GLP APPLICATIONS
Therapeutic Development
Sequence confirmation support throughout preclinical development and clinical trials
Medical and IVD Devices Development
Orthogonal testing for validation of in vitro diagnostic accuracy to support US FDA CDRH medical device applications
Diagnostic Confirmatory Mutation Analysis
Confirmation of deleterious patient genomic alterations utilizing orthogonal platform technologies in support of diagnostics
Biomarkers and Pharmacogenomics
Confirmation of known biomarkers in preclinical and clinical samples
Cell Bank/Line Development
Confirmation of viral, bacterial, and human cell lines and cell banks, pre- and post- manufacturing, prior to use in therapeutics
Agricultural Product Development
GLP GMO and plant strain Identification, as per 40CFR part 160 for EPA compliance
CLIA AND GLP SERVICES
Including regulated Sanger and next generation sequencing, plasmid preparation, and pre-analytical bio-fluid processing.
SAMPLE MANAGEMENT
From sample collection and storage, through sample processing, sequencing, analysis, and reporting, regulatory services team-up to support your regulatory needs. Access comprehensive sample management solutions to gain confidence that your samples are safe and optimized, and your program has the best chance of success.
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Sample Collection
& TransportAzenta Life Sciences offers sample kitting and cold-chain logistics with real-time sample tracking to securely transport samples to our storage facilities.
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Sample Storage
& ManagementSamples are stored in Azenta Life Sciences; CAP, ISO 9001-accredited, GGP-compliant facilities with 24/7 access to our 21 CFR Part 11- compliant software.
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Sample Retrieval
& Pre-ProcessingGENEWIZ’s pre-analytical processing, such as extractions, PMBC isolations, and aliquoting, are performed in our CAP-accredited, GxP-compliant laboratories.
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Sequencing, Prep,
& Data Analysis
FEATURES & BENEFITS
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Custom assay development and validations to support specific regulatory submissions
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Adheres to the highest regulatory standards with compliance to GMP (as applicable to our services), GCP, and GLP guidelines
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Superior data quality that exceeds manufacturer’s benchmarks & Ph.D.-level support during your entire project, including free consultations
Technical Resources
Case Study | Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial
A biopharma company required a partner for clinical trial support, with an immediate need for development and validation of a biomarker assay using next generation sequencing with a quick turnaround time. Read the case study to learn how this company was able to streamline clinical testing and accelerate the timeline of its phase 1/2 study.
