Cell & Gene Analytics

Bioinformatics

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Bioinformatics—Clinical Data Analytics with Interpretation

Our proprietary data analysis and interpretation pipelines are a vital pillar of our service offerings for gene therapy safety assessment. Our highly accomplished bioinformatics team analyzes primary data from our assays to gain deep biological insights to answer specific safety concerns.

Safety concerns addressed include integration site analysis for pre-clinical and clinical studies, on-/off-target analysis for gene therapy safety assessment, vector quality control, and immune repertoire analysis.

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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