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Preclinical and Clinical Solutions

Industry-leading cell and gene therapy solutions for preclinical support and multi-phase clinical trial development and study execution.


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.


Vector - Clinical


Perform animal safety studies and develop master cell and virus banks.

Services include: GLP and RUO AAV-ITR Sanger Sequencing, Animal-Free Plasmid Preparations, Plasmid Sequencing Confirmation, and Digital PCR (dPCR)

Trials - Clinical


Sample and critical reagent management for clinical trials from Azenta.

Services include: Clinical Trials Sample Management, Patient Safety Testing via CLIA-Grade Sanger, NGS Sequencing, Drug Products Storage & Logistics, and Integration Site Analysis


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 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.

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Drug Product Storage & Logistics

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
Automated Cryogenic Storage

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)

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Sample Management & Analytics

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
GLP Sanger 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
Whole 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
Animal-free plasmid preparation

Transition to preclinical safety studies with animal- and endotoxin-free GLP-compliant plasmid preparations.


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.


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.

Biosample Thermal Protection White Paper

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Cryogenic Cold Chain Management White Paper

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Preserving the Innocents: Biosample Storage at -190ºC

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Best Practices for Introducing -80°C Biosamples into -190°C Vapor Phase LN2 Freezers

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Sample Warming During Innocent Exposure from an LN2 Freezer White Paper

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The Effects of Common Transient Warming Events on Post Thaw Recovery and Viability

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Transient Warming Rates of 250ML Cryopreservation Bags

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The Effects of Storage Temperature and Repetitive Temperature Cycling

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BioStore Automated LN2-Based Storage & Handling Solutions

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Drug Products Storage and Distribution for Cell and Gene Therapy

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Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial

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Overcoming Unconventional Supply Chain Challenges to Scale-Up and Scale-Out Cell Therapy Delivery

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Cell/Viral Line Development

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Clinical Analytical Capabilities & Services

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GLP-Compliant Capabilities

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AAV-ITR Sanger Sequencing Solutions

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Digital PCR (dPCR)

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Preparing for scalable

cell and gene therapy solutions


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.