BRING YOURCGT CANDIDATESFARTHER,FASTER
Advances in technology have reached an inflection point, and cell and gene therapies aretaking off. You need a proven partner who can expertly support your research breakthrough,while transcending expectations at every phase of development.

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INCREASING CHALLENGES

Rise above the uncertainty
and complexity of development
SCALING UP
Rigor and reproducibility are essential as therapies advancetoward approval.
PROTOCOL AMBIGUITY
Inadequately defined protocols for emerging and existing therapies
can lead to roadblocks.
SAMPLE MANAGEMENT
Cold chain logistics and storage challenges complicate clinical trials
and manufacturing.

ELEVATE YOUR SCIENCE

Transcend expectations
Azenta Life Sciences can help you address these challenges proactively.
We have the infrastructure, technologies, and expertise to help you mitigate
risk while accelerating development.

GLOBAL STORAGE LOCATIONS& LOGISTICS NETWORKPROPRIETARYGENOMICS PROTOCOLSAUTOMATED SOLUTIONSINDUSTRY EXPERTS

From cell banks to cGMP materials andCustomers rely on our proprietary hairpin

Deep application experience andWe will guide you through common

finished products, our trained staff andand GC-rich protocols to sequence andproven technologies protect sample

certified facilities specialize in cold chain

synthesize long and difficult DNA

integrity across all temperatures.

storage, management, and documentation.

sequences with superior results.

challenges of advanced therapy
development.

Preparing for scalable CGT solutions
Azenta Life Sciences provides a comprehensive range of solutions across every phase of CGT development.
We'll support the rigor of your program all the way from target discovery through scale-out.

Discovery

TargetDiscovery

Lead Generation& Characterization
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Manufacturing &Distribution Logistics

Pre-Clinical& Clinical

Vector & Cell
Bank Confirmation

Clinical Trial
Management

Logistics &Distrbution Scale-up

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Therapeutics
ManagementSEE MORE

• Transcriptome analysis with RNA-seq(bulk or single-cell)• Whole AAV genome sequencing (short- andlong-read technologies for AAV or lentivirus)• Integration Site Analysis (RUO)• Transcriptome analysis with RNA-seq
bulk (RUO/CLIA) or single-cell (RUO)• Whole AAV genome sequencing (shortand long-read technologies for AAV orlentivirus)• Integration Site Analysis (RUO, CLIA)

Synthetic DNASolutions• Gene synthesis and viral production bundle (AAVpackaging, lentivirus, baculovirus)• AAV Gene Synthesis (fragments, cloned products)• AAV Plasmid Preparation (RUO)• CRISPR Synthetic DNA Solutions• AAV Gene Synthesis (fragments, clonedproducts; pre-clinical)

Sanger-basedSequencing• AAV-ITR Sanger Sequencing (RUO)• AAV-ITR Sanger Sequencing (RUO, GLP)• AAV-ITR Sanger Sequencing (GLP)• Labware and benchtop cold chain instruments• Informatics and Data Management solutions• 21-CFR-11 Data and reporting solutions• Automated cryogenic storage andtransport• Cryopod and Filling station• 21-CFR-11 Data and reporting solutions• Automated cryogenic storage and transport• Master/Working cell banks, GMP raw
materials, critical reagents, QC retains,reference materials, and finishedtherapeutics• Clinical Trials Sample Management• Master cell banks, GMP raw materials andother critical reagents, QC retain sample
programs• Global storage and distribution partner for
CGT-related drug materials and finishedproducts

Next-Generation
Sequencing

Automated Storage andCold Chain Products

Sample and MaterialStorage Solutions

Digital PCR (dPCR)• Low-abundance target detection, viral titer, andvector copy number (RUO)• Low-abundance target detection, viraltiter, and vector copy number (CLIA)

REDEFINE WHAT’S POSSIBLE

Discovery

The shortest route to a breakthrough is rarely a straight line. Azenta's technologies, innovations,and proprietary protocols give you an extra dimension of agility to sequence and confidently
characterize your products.

TARGET DISCOVERY
Analyze disease samples to find mutations, then validate targets.
Services include: RNA Sequencing, Mutation Analysis,
Oligo Synthesis, Cell Line Engineering Confirmation, and Digital PCR (dPCR)

LEAD GENERATION & OPTIMIZATION
Identify and refine leads; test leads and delivery mechanisms for efficacy.
Services include: RNA Sequencing, CRISPR Validation Services, gRNA
Construct Synthesis, AAV-ITR Sanger Sequencing, Whole AAV GenomeSequencing, Synthetic DNA Solutions, and Viral Production Bundle (AAVPackaging, Lentivirus, Baculosvirus)

AAV Genomics Solutions
Azenta has developed a suite of proprietary genomics protocols for working with the complexities of AAV.

AAV GENOMICS SERVICESAAV GENOMICS PROTOCOLSAs a global leader in genomics services, Azenta has developed unique AAV-ITR
sequencing, AAV plasmid synthesis, and AAV plasmid preparation capabilities tosupport scientists in their in vivo gene therapy research. Azenta's groundbreaking
AAV services also include sequence verification and correction of inverted
terminal repeat (ITR) regions, which are crucial for rAAV packaging production, andAAV-ITR Sanger

AAV Plasmid

AAV Plasmid

Sequencing

Preparation

Synthesis

AAV GenomeAAVDigital PCR

Sequencing

Packaging(dPCR)

digital PCR (dPCR) for viral titer.

VIEW SERVICEYOUR VISION IS NOW WITHIN REACH

Pre-Clinical & Clinical
Azenta Life Sciences offers complete sample management and genomic safety testing solutions
that enable improved study timelines with increased sample integrity and sample utilization. Our
extensive experience in managing clinical trials spans all therapeutic areas, regardless of phaseor size, within one global, interconnected platform. Our experts will work with you to customize
our suite of services to fit your individual sample management needs.

VECTOR & CELL BANK CONFIRMATION
Perform animal safety studies and verify the genetic stability of your master celland virus banks.
Services include: GLP and RUO AAV-ITR Sanger Seqencing, Animal-free Plasmid
Preparations, GLP Plasmid Sequencing Confirmation, and Digital PCR (dPCR).

CLINICAL TRIALS
Partner with Azenta for sample and critical reagent management for clinical trials.
Services include: Clinical Trials Sample Management, Patient Safety Testing via
CLIA-grade Sanger and NGS sequencing, Drug Products Storage & Logistics, andIntegration Site Analysis (RUO, CLIA).

Clinical Trials Solutions
Viral whole genome sequencing (short-read, long-read: RUO; for AAV or lentivirus)

CLINICAL TRIALS SOLUTIONSCLINICAL TRIALS SOLUTIONSClinical Trials are a crucial step in cell and gene therapeutic development, withmany logistical challenges. Azenta offers comprehensive solutions to minimize
risk and improve sample quality for all clinical trial phases. Our global network ofbiorepositories and laboratories — in combination with industry-leading cold
chain logistics and products — facilitate clinical studies around the world.
Clinical Trials Sample
Management

Drug Product & Critical Reagent
Storage & Distribution

Patient Genomic
Safety Testing

VIEW SOLUTIONSEXCEED IMPOSSIBLE STANDARDSManufacturing & Distribution
Support the integrity of your breakthrough cure from scale-up to scale-out to patient withthe most advanced cold chain logistics, automated tools, onsite, offsite, and hybrid services.

LOGISTICS AND DISTRIBUTION SCALE-UP
Leverage modular, scalable automated cryogenic storage systems toseamlessly support manufacturing and distribution scale-up, withintegrated data management and reporting plus full audit trail tracking.
Solutions Include: BioStore Cryogenic Automated Storage System.

THERAPEUTICS MANAGEMENT
Flexible pharmaceutical cold chain logistics and distribution solutions tosafeguard the integrity and quality of your drug products, critical reagents,and raw materials, while meeting cGMP and regulatory requirements.
Services include: Drug Products and Cell Therapies.

Automated Cryogenic Storage
With 10 years and $100M invested in R&D, Azenta Life Sciences is setting the new world
standard in cryopreservation. Our -190oC Cryogenic Freezer is the best-in-class automatedsolution for cellular products and other materials requiring temperatures below glasstransition (Tg). The patented cryogenic tank design can locate, lift, and deliver target
materials to the system user.

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Empower your team to transcend expectations at
https://web.azenta.com/cell-and-gene-therapy
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Risk Mitigation

Process Control

Data & Reporting