Cell & Gene Analytics

Vector Characterization

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Vector Analytics

ProtaGene’s scientists are at the forefront of analytics for characterizing a broad range of gene therapy vectors from development through scale-up and approvals, including minimizing risk for patients in clinical trials and beyond. We provide the full spectrum of assays for vector characterization and quality control in line with current FDA and EMA regulatory guidelines.

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Vector Characterization with PTM and Nucleic Acid Analysis

Strategic early application of advanced analytical techniques can help improve the selection of vector candidates and guide development decisions. Ultimately, early analytical exploration leads to a more significant number of safer, more efficacious cell and gene therapies successfully reaching the market.

Understanding the specific structural attributes of vector proteins influencing clinical delivery and outcomes is essential for advancing individual candidates and the platforms on which they are based. At the same time, both protein and nucleic acid analysis are critical to evaluate in order to ensure vector product safety. ProtaGene’s vector characterization analytical offering includes analyses such as:

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    Capsid primary sequence and PTM analysis
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    Forced degradation programs
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    Host cell protein analysis/ELISA correlation by LCMS
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    Residual host-cell DNA/RNA and helper plasmid analysis
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    Empty/complete vector particle analysis
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    Vector genome analysis
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Vector Product and Process Development

Our portfolio includes a comprehensive suite of analytical methods to address the clinical development of complex cell and gene therapy products, including full characterization panels and GMP QC lot release and stability methods.

Our global sites are equipped with modern, state-of-the-art equipment run under advanced quality systems and GMP for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, and thermal stability. We offer service modules for gene-based analytical support from research to market, including:

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    Developability and Lead Selection
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    Formulation Development
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    Scale-up and Process Comparability
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Vector Manufacturing and QC

Early strategic approaches and the application of advanced analytics before critical stages can improve product development, manufacturing, and clinical outcomes. ProtaGene offers industry-leading approaches and specialized expertise to help advance you in manufacturing and product-facing analytical programs such as:

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    Method Development for Manufacturing and Process Analytics
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    ICH/ GMP Validation
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    QC-Lot Release
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    Stability Program Management
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    Analytical Life Cycle Management

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

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
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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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