Cell & Gene Analytics

Integration Site Analysis


Integration Site Analysis

As novel gene therapies enter development pipelines, regulatory bodies adapt their guidelines to ensure their continued safety. Actively and passively integrating (viral) vectors may trigger adverse effects by undirected or unintended integration into the target cell’s genome.

Integration Site Analysis (ISA) is the key tool to assess the biosafety of gene therapy vectors by characterizing their integration profiles, as well as for clonal tracking of genetically modified cells in vivo. Complementary and particularly designed for long term follow-up studies, customized integration site-specific qPCR assays provide an orthogonal method to confirm eventual clonal events.

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    Vector copy number

Pioneered by GeneWerk

Now a vital part of ProtaGene’s robust analytical capabilities, Integration Site Analysis was developed by gene therapy pioneers and industry leaders who continue to set the standard for vector safety and integration site analysis.

Invented by Dr. Manfred Schmidt and Professor Dr. von Kalle more than two decades ago, now ProtaGene scientists work with global clients on their novel cell and gene therapies to ensure regulatory safety requirements are met.

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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