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.
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.
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, Plasmid Sequencing Confirmation, and Digital PCR (dPCR)
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, NGS Sequencing, Drug Products Storage & Logistics, and 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 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
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.
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)
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
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 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
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.
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
Download PDF >Cryogenic Cold Chain Management White Paper
Download PDF >Preserving the Innocents: Biosample Storage at -190ºC
Download PDF >Best Practices for Introducing -80°C Biosamples into -190°C Vapor Phase LN2 Freezers
Download PDF >Sample Warming During Innocent Exposure from an LN2 Freezer White Paper
Download PDF >The Effects of Common Transient Warming Events on Post Thaw Recovery and Viability
Download PDF >Transient Warming Rates of 250ML Cryopreservation Bags
Download PDF >The Effects of Storage Temperature and Repetitive Temperature Cycling
Download PDF >BioStore Automated LN2-Based Storage & Handling Solutions
Download PDF >Drug Products Storage and Distribution for Cell and Gene Therapy
Download PDF >Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial
Download PDF >Overcoming Unconventional Supply Chain Challenges to Scale-Up and Scale-Out Cell Therapy Delivery
Download PDF >Cell/Viral Line Development
Download PDF >Clinical Analytical Capabilities & Services
Download PDF >GLP-Compliant Capabilities
Download PDF >AAV-ITR Sanger Sequencing Solutions
Download PDF >Digital PCR (dPCR)
Download PDF >DELIVER CELL AND GENE THERAPIES
Preparing for scalable
cell and gene therapy solutions
PRECLINICAL AND CLINICAL SOLUTIONS UPDATES
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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.