Cell & Gene Analytics

Genome and Gene Editing Analysis


Genome and Gene Editing Analytics

Genome editing using designer nucleases such as CRISPR/Cas9, ZFNs, and TALENs allow the targeted introduction of genetic material into a specific locus. However, undesired genome modifications potentially disrupting the functionality of otherwise normal genes may arise, thus raising safety concerns.

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On- and Off-Target Analysis

ProtaGene offers a versatile and cost-effective assay for gene editing safety assessment. We adapted our Shearing Extension Primer Tag Selection Ligation-Mediated PCR (S-EPTS/LM PCR) method for the genome-wide detection and quantification of on- and off-target alterations. In combination with robust in-house bioinformatics pipelines, our assay reliably quantify the ratios between the desired targeted integration and non-desired outcomes such as translocations and indels.

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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, immunotherapy monitoring, gene therapy development, or infectious diseases.

The advent of high-throughput sequencing technologies have allowed for the comprehensive monitoring of the immune repertoire size, diversity and dynamics.

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

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Analytical Solutions from Research to Market

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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

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Cell and Gene Therapeutic Platform Expertise

Our deep experience assembling a broad range of cell and gene 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 cell and gene 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

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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