Cell & Gene Analytics

Gene Expression Analysis

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Gene Expression Analysis

Quantitative analysis of gene expression products in vivo can evaluate and optimize cell and gene therapy platforms. In many cases, there is a substantial background of highly similar protein already present in the tissue.

MS-based analysis provides an accurate and sensitive method for quantifying and differentiating therapeutic expression from the background that can be used to track the persistence of therapeutic protein over time.

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    Expression Product Monitoring—Quantitative assessments by LCMS

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    Expression Product Characterization—CQA assessments by LCMS

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    Pre-Clinical Cell Therapy—Clinical correlations of product expression

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    Patient Exposure for Trial Design and Assessment

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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