Cell & Gene Analytics

Genetic Analytics

Genetic Analytics

Genome editing using designer nucleases such as CRISPR/Cas9, ZFNs, and TALENs allow the targeted introduction of genetic material into a specific locus of the mammalian genome. However, undesired on- and off-target genome modifications may arise, which could cause genomic instability and disrupt the functionality of otherwise normal genes, potentially causing safety concerns in pre-clinical and clinical studies. Additionally, immune responses generated by gene therapy must be well understood.

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On- and Off-Target Analysis

ProtaGene offers comprehensive PCR and NGS-based assays for gene editing safety assessment. Our versatile and cost-effective assays interrogate both on- and off-target genomic alterations. In combination with robust in-house bioinformatics pipelines, our state-of-the-art assays reliably quantify the ratios between the desired targeted integration and non-desired outcomes such as translocations and indels.

We adapted the Shearing Extension Primer Tag Selection Ligation-Mediated PCR (S-EPTS/LM PCR) method to analyze on-target and off-target integrations arising from genome editing and use target enrichment sequencing (TES) for genome-wide detection and quantification of on- and off-target alterations.

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    PCR-Based
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    NGS-Based
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Immune Repertoire Analysis

Adaptive immune response generates T cell and B cell receptors (TCRs and BCRs) that comprise an organism’s immune repertoire. Immune repertoire analysis has many applications, including cancer diagnosis and treatment, gene therapy development, and infectious diseases.

Several high-throughput technologies have emerged which allow comprehensive monitoring of the immune repertoire over time.

Although we have progressed from low-throughput to high-throughput analysis techniques, several challenges remain. Streamlined experimental pipelines for unique applications and customized bioinformatics tools for data analysis remain underdeveloped.

ProtaGene offers PCR- and target enrichment sequencing-based approaches for customized, high-throughput, and simultaneous analysis of T cell and B cell receptors from a wide range of sample input material.

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    TES-Based
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    RACE-PCR
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    Vector Copy Number

Analytical Solutions from Research to Market

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Research
Preclinical
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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

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Phase I
Phase II
Phase III
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Phase I – Phase III

Release, Clinical Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

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Registration
Market
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Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Gene & Cell Therapeutic Platform Expertise

Our deep experience assembling a broad range of gene and cell therapy platforms from research through commercialization helps the ProtaGene team design highly effective analytical programs that de-risk development and accelerate timelines to your next key milestones. Key gene and cell therapy platform development areas include:

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    Capsid-based Vectors

    • AAVs (Multiple Serotypes and Engineered Vectors)
    • Novel Systems
    • Adenovirus
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    Complex, Envelope Vectors

    • Lentivirus
    • Gammaretrovirus 
    • Novel Viruses
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    Non-viral Vectors

    • Polynucleotide (RNA/DNA) Formulations
    • Lipid Nanoparticles
    • Transposons
    • Plasmids
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    Genetic Engineering

    • TALEN
    • CRISPR/Cas9
    • Zinc-finger Nucleases
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Analytical Systems

Enabled by state-of-the-art technology, ProtaGene offers an extensive range of analytical capabilities to support your biotherapeutic or gene & cell therapy projects.

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