GENEWIZ REGULATED SERVICES

GCP, GLP, and GMP 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 Clinical Practices (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.

Evolution of Sample Management And Automation in Drug Discovery


Webinar: Cold Storage and Sample Integrity

In this webinar with ISBER, biorepository and cryopreservation experts discuss the fundamental elements to achieve consistency and reproducibility in research.




 

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.

  • Sample Collection
    & Transport

    Azenta Life Sciences offers sample kitting and cold-chain logistics with real-time sample tracking to securely transport samples to our storage facilities.

  • Sample Storage
    & Management

    Samples are stored in Azenta Life Sciences’ CAP ISO 9001-accredited, GXP-compliant facilities with 24/7 access to our 21 CFR Part 11- compliant software.

  • Sample Retrieval
    & Pre-Processing

    GENEWIZ’s pre-analytical processing, such as extractions, PMBC isolations, and aliquoting, are performed in our CAP-accredited, GxP-compliant laboratories.

  • Sequencing, Prep,
    & Data Analysis

    CAP/CLIA-certified GENEWIZ laboratory offers a wide range of Sanger and NGS services for clinical research with compliance to GCP/GLP guidelines.

FEATURES & BENEFITS

  • Custom assay development and validations to support specific regulatory submissions

  • Adheres to the highest regulatory standards with GLP/GCP compliance and CAP/CLIA certification

  • Superior data quality that exceeds manufacturer’s benchmarks & Ph.D.-level support during your entire project, including free consultations

  • Complementary NGS and Sanger services provide variant discovery-to-validation workflows

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.