Cell & Gene Analytics

GeneWerk Integration Site Analysis

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GeneWerk 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.

GeneWerk Integration Site Analysis (ISA) is the key tool to assess the biosafety of gene therapy vectors and the clonal tracking fate of genetically modified cells in vivo. According to FDA and EMA guidance for viral-vector-based therapies, integration site analysis should be undertaken to monitor integration frequency and site identification once the vector integration is confirmed.

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    S-EPTS/LM PCR

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    TES

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    (nr)-LAM-PCR

Powered by GeneWerk

Now a vital part of ProtaGene’s robust analytical capabilities, GeneWerk 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, GeneWerk scientists work with global clients to develop novel cell and gene therapies that meet regulatory safety requirements and de-risk their cell and gene therapy development journey.

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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