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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.

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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.

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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, Animal-Free Plasmid Preparations, and Plasmid Sequencing Confirmation


Trials - Clinical

CLINICAL TRIALS

Sample and critical reagent management for clinical trials from Azenta.

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

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 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.

Whole Viral Genome Sequencing
Automated Cryogenic Storage

Enable scale-up with Azenta’s BioStore LN2-Based Automated Storage System, providing a best-in-class solution 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.

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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.

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.

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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.

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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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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DELIVER CELL AND GENE THERAPIES

Preparing for scalable

cell and gene therapy solutions

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.