Cell & Gene Analytics

Gene Expression Quantitation


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 cellular mRNA or 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. Our portfolio also includes qPCR- and NGS-based assays allowing for transgene and cellular (m)RNA detection and quantification.

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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

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    Transgene and cellular gene (m)RNA – RT-qPCR and RNA sequencing

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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