--- title: Cell and Gene Therapy | Preclinical and Clinical Research description: Industry-leading cell and gene therapy solutions for preclinical and clinical trial development and study research. --- [![Azenta Life Sciences](https://web.azenta.com/hubfs/Azenta%20Logo%20and%20Brand%20Assets/Azenta%20Logos/Azenta_Logo_Hubspot_FullColor.svg "Azenta Life Sciences")](https://www.azenta.com) Open main menu Close main menu [HOME](https://web.azenta.com/cell-and-gene-therapy?hsLang=en) [DISCOVERY](https://web.azenta.com/cell-and-gene-therapy/discovery?hsLang=en) [PRECLINICAL & CLINICAL](https://web.azenta.com/cell-and-gene-therapy/clinical) [MANUFACTURING & DISTRIBUTION](https://web.azenta.com/cell-and-gene-therapy/manufacturing?hsLang=en) [CONTACT AN EXPERT](https://web.azenta.com/cell-and-gene-therapy-contact-an-expert?hsLang=en) ![](https://web.azenta.com/hs-fs/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/Overview%20Landing%20Page/00_StickyNav/push%20up.png?width=50&name=push%20up.png) # CELL AND GENE THERAPY ## Preclinical and Clinical Solutions Industry-leading cell and gene therapy solutions for preclinical support and multi-phase clinical trial development and study execution. [CONTACT US](https://web.azenta.com/cell-and-gene-therapy-contact-an-expert?hsLang=en) ## PRE-CLINICAL AND CLINICAL TRIAL SOLUTIONS ## Harness the convenience of *centralized clinical trial services* for cell and gene therapy Azenta's comprehensive clinical trial products and services  support a wide range of challenges, including pre-existing and treatment-induced immunity to viral vectors, and gene therapies targeting rare diseases. ![Azenta_PreClinical_ReproduceResults_Image](https://web.azenta.com/hubfs/Azenta_PreClinical_ReproduceResults_Image.png "Azenta_PreClinical_ReproduceResults_Image") --- ![Vector - Clinical](https://web.azenta.com/hs-fs/hubfs/Vector%20-%20Clinical.png?width=54&height=47&name=Vector%20-%20Clinical.png "Vector - Clinical") ### VECTOR & CELL BANK CONFIRMATION Perform animal safety studies and develop master cell and virus banks. Services include: [GLP and RUO AAV-ITR Sanger Sequencing](https://www.genewiz.com/en/Public/Services/Sanger-Sequencing/AAV-ITR), [Animal-Free](https://www.genewiz.com/en/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep)[Plasmid Preparations](https://www.genewiz.com/en/Public/Services/Plasmid-DNA-Prep/AAV-Plasmid-Preparation), [Plasmid Sequencing Confirmation,](https://www.genewiz.com/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing)and [Digital PCR (dPCR)](https://www.genewiz.com/Public/Services/Molecular-Genetics/PCR-Solutions) --- ![Trials - Clinical](https://web.azenta.com/hs-fs/hubfs/Trials%20-%20Clinical.png?width=68&height=42&name=Trials%20-%20Clinical.png "Trials - Clinical") ### CLINICAL TRIALS Sample and critical reagent management for clinical trials from Azenta. Services include: [Clinical Trials Sample Management](https://www.azenta.com/clinical-trial-management?ls=sutm_source=Linkedin&utm_medium=Organic&utm_campaign=CT_Awareness_savings), [Patient Safety Testing via CLIA-Grade Sanger](https://www.genewiz.com/Public/Services/Clinical-Services/Clinical-Services-Overview), [NGS Sequencing, Drug Products Storage & Logistics](https://www.genewiz.com/Public/Services/Clinical-Services/Clinical-Services-Overview), and [Integration Site Analysis](https://www.genewiz.com/Public/Services/Clinical-Services/CLIA-Integration-Site-Analysis) ## CLINICAL TRIAL PRODUCTS & SERVICES ## Customized clinical trial solutions for ## *cell and gene **therapy development* Azenta Life Sciences offers a comprehensive range of solutions to support all your clinical and regulatory needs, customized to your specifications. - [CLINICAL TRIAL SOLUTIONS](https://web.azenta.com/cell-and-gene-therapy/clinical#tab-1) - [VECTOR BANK & CELL LINE CONFIRMATION](https://web.azenta.com/cell-and-gene-therapy/clinical#tab-2) ## Clinical Trials Solutions Azenta Life Sciences offers a global network of biorepositories and laboratories — in combination with industry-leading cold-chain logistics and products — to facilitate clinical studies around the world. ![Drug Product storage & Logistics Blue](https://web.azenta.com/hubfs/Drug%20Product%20storage%20%26%20Logistics%20Blue.svg) ##### [Drug Product Storage & Logistics](https://www.azenta.com/cold-storage-and-distribution-drug-products) Azenta specializes in cGMP controlled cold chain storage as well as cold chain management to help safeguard the integrity of your cell and gene therapies. ![Biostores and Cryo Store Pico](https://web.azenta.com/hs-fs/hubfs/2022-01%20CGT%20Umbrella/biostore%20and%20pico%20tri%20(1).png?width=300&height=225&name=biostore%20and%20pico%20tri%20(1).png) ##### [Automated Cryogenic Storage](https://www.azenta.com/products/automated-storage-systems/190%C2%B0C) Enable scale-up with the Azenta BioStore LN2-Based Automated Storage System, or the new Cryo Store Pico™, which provides secure access and fits spaces from lab to clinic for storage below glass transition (Tg) ![Analytical WhiteBlue (1)](https://web.azenta.com/hubfs/Analytical%20WhiteBlue%20(1).svg) ##### [Sample Management & Analytics](https://www.azenta.com/clinical-trial-management) Complete, integrated sample management and analytics solutions, including pre-analytical sample processing and sequencing in our CAP/CLIA lab. ## Vector Bank & Cell Line Confirmation Perform animal safety studies and develop master cell and virus banks. ![GLP Sanger Sequencing](https://web.azenta.com/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/PreClinical_Clinical%20Page/03_Products%20and%20Services/Vector%20Bank%20and%20Cell%20Line%20Confirmation/GLP%20Sanger%20Sequencing.svg) ##### [GLP Sanger Sequencing](https://www.genewiz.com/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing) Provides confirmation of your biologic and verification of genetic stability to support FDA submissions. Capabilities include proprietary AVV-ITR sequencing, PCR + Sanger, and primer walking. ![Whole Genome Sequencing Blue](https://web.azenta.com/hubfs/Whole%20Genome%20Sequencing%20Blue.svg) ##### [Whole Viral Genome Sequencing](https://www.genewiz.com/Public/Services/Next-Generation-Sequencing/Viral-Genome-Sequencing/) Employ long-read NGS to examine genome integrity, detect heterogeneity, and reveal packaging attributes. Analyze host response utilizing RNA-seq and other approaches.   ![Animal-Free Plasmid Preparation](https://web.azenta.com/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/PreClinical_Clinical%20Page/03_Products%20and%20Services/Vector%20Bank%20and%20Cell%20Line%20Confirmation/Animal-Free%20Plasmid%20Preparation.svg) ##### [Animal-free plasmid preparation](https://www.genewiz.com/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep) Transition to preclinical safety studies with animal- and endotoxin-free GLP-compliant plasmid preparations. ## EXPERT INSIGHT ## Navigating the Complexities of Cell and Gene Therapy Clinical Trial Sample Management Clinical trials for cell and gene therapies involve many cold chain complexities. Managing these novel products as well as clinical samples requires robust and adaptable systems to ensure safety, integrity, and regulatory compliance. [READ MORE](https://www.azenta.com/blog/navigating-complexities-cgt-clinical-trial-sample-management) ## CLINICAL TRIAL RESOURCES ## Learn more about our preclinical and clinical approach to *cell and gene* *therapy **automation and cryogenics* Accelerate your preclinical and clinical trials with an integrated and scalable process that includes automation and cryogenics. Have questions? Azenta's team of scientists and experts can provide additional assistance. - [WHITE PAPERS](https://web.azenta.com/cell-and-gene-therapy/clinical#tab-1) - [BROCHURES & CASE STUDIES](https://web.azenta.com/cell-and-gene-therapy/clinical#tab-2) Biosample Thermal Protection White Paper [Download PDF >](https://www.azenta.com/resources/thermal-protection-protecting-excursions-cryogenically-frozen-vials-during-transient) Cryogenic Cold Chain Management White Paper [Download PDF >](https://www.azenta.com/resources/cryogenic-cold-chain-management-protecting-bio-sample-temperatures-using-automation-best) Preserving the Innocents: Biosample Storage at -190ºC [Download PDF >](https://www.azenta.com/resources/preserving-innocents-biosample-storage-190-c) Best Practices for Introducing -80°C Biosamples into -190°C Vapor Phase LN2 Freezers [Download PDF >](https://www.azenta.com/resources/best-practices-introducing-80-c-biosamples-190-c-vapor-phase-ln2-freezers) Sample Warming During Innocent Exposure from an LN2 Freezer White Paper [Download PDF >](https://www.azenta.com/resources/sample-warming-during-innocent-exposures-ln2-freezer-comparing-temperature-time-workflow) The Effects of Common Transient Warming Events on Post Thaw Recovery and Viability [Download PDF >](https://www.azenta.com/resources/effects-common-transient-warming-events-post-thaw-recovery-and-viability) Transient Warming Rates of 250ML Cryopreservation Bags [Download PDF >](https://www.azenta.com/resources/transient-warming-rates-250ml-cryopreservation-bags) The Effects of Storage Temperature and Repetitive Temperature Cycling [Download PDF >](https://www.azenta.com/resources/effect-storage-temperature-and-repetitive-temperature-cycling-post-thaw-functionality) BioStore Automated LN2-Based Storage & Handling Solutions [Download PDF >](https://www.azenta.com/resources/thermal-protection-protecting-excursions-cryogenically-frozen-vials-during-transient) Drug Products Storage and Distribution for Cell and Gene Therapy [Download PDF >](https://web.azenta.com/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/PreClinical_Clinical%20Page/Clinical%20Sell%20Sheets/72001-SD-1%201221V1%20CGT%20Storage%20%26%20Logistics%20Sell%20Sheet.pdf?hsLang=en) Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial [Download PDF >](https://hubs.ly/Q01V2TnL0) Overcoming Unconventional Supply Chain Challenges to Scale-Up and Scale-Out Cell Therapy Delivery [Download PDF >](https://www.azenta.com/blog/navigating-complexities-cgt-clinical-trial-sample-management?hsLang=en) Cell/Viral Line Development [Download PDF >](https://web.azenta.com/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/PreClinical_Clinical%20Page/Clinical%20Sell%20Sheets/16005-SD%201221%20GLP%20Cell%20Line%20Development%20Sell%20Sheet.pdf?hsLang=en) Clinical Analytical Capabilities & Services [Download PDF >](https://web.azenta.com/hubfs/2022%20Cell%20and%20Gene%20Therapy%20Campaign/PreClinical_Clinical%20Page/Clinical%20Sell%20Sheets/16003-SO%200122%20Clinical%20Services%20Sell%20Sheet.pdf?hsLang=en) GLP-Compliant Capabilities [Download PDF >](https://web.azenta.com/hubfs/16004-SO%201221%20GLP%20Compliant%20Services%20Sell%20Sheet%20(1).pdf?hsLang=en) AAV-ITR Sanger Sequencing Solutions [Download PDF >](https://web.azenta.com/hubfs/11001-SD%201221%20AAV-ITR%20Sequencing%20Sell%20Sheet.pdf?hsLang=en) Digital PCR (dPCR) [Download PDF >](https://web.azenta.com/hubfs/2022-01%20CGT%20Umbrella/11030-SO%200623%20qPCR%20%26%20dPCR%20Sell%20Sheet.pdf?hsLang=en) ## DELIVER CELL AND GENE THERAPIES ## Preparing for scalable ## *cell and gene therapy solutions* ### [Discovery ](https://web.azenta.com/cell-and-gene-therapy/discovery?hsLang=en) #### [BIOINFORMATICS | AUTOMATION & CRYOGENICS](https://web.azenta.com/cell-and-gene-therapy/discovery?hsLang=en) ### [Manufacturing & Distribution ](https://web.azenta.com/cell-and-gene-therapy/manufacturing?hsLang=en) #### [MANUFACTURING SCALE-UP | THERAPEUTICS MANAGEMENT](https://web.azenta.com/cell-and-gene-therapy/manufacturing?hsLang=en) ## PRECLINICAL AND CLINICAL SOLUTIONS UPDATES ## Subscribe for cell and gene therapy *preclinical and clinical therapy updates* Want to validate, optimize, or scale up right now? Need to know what's next? Connect with Azenta Life Sciences, leading the way in cell and gene therapies infrastructure and expertise. ![Azenta_Logo_Primary_FullColor_BlackType_RGB_JP](https://web.azenta.com/hs-fs/hubfs/ja-jp/JP_images/Azenta_Logo_Primary_FullColor_BlackType_RGB_JP.png?width=200&height=66&name=Azenta_Logo_Primary_FullColor_BlackType_RGB_JP.png "Azenta_Logo_Primary_FullColor_BlackType_RGB_JP") - - - - Copyright © 2022 Azenta US, Inc.    [Privacy Policy](https://www.azenta.com/privacy-statement)   |   [Cookie Policy](https://www.azenta.com/cookie-policy)   |   [Terms and Conditions](https://www.azenta.com/terms-and-conditions)   |    [Terms of Use](https://www.azenta.com/terms-and-conditions)    |     [Careers](https://careers.azenta.com/)