Analytical Excellence

Accelerating Today’s Therapeutics

Leading global pharmaceutical organizations and emerging biopharma and gene and cell therapy companies trust ProtaGene’s analytical excellence, deep experience, and quality systems to accelerate and de-risk their therapeutic development programs.

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Analytical Solutions from Research to Market

Our scientific expertise, experience across a wide range of therapeutics and regions, multi-continent foundation, and commitment to quality provide complete analytic solutions for protein biologics and gene and cell therapeutics throughout products’ development and regulatory life cycles—from discovery 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

Biologic Drug
Analytics

Expertise in characterization, advanced method development, late-stage and GMP commercial sample testing under GMP, and complete data packages for all stages of biotherapeutic development—from clone to commercialization.

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    mAbs

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    Bispecifics/Multispecifics

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    Recombinant Proteins—Including Complex, Highly Glycosylated Proteins

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    Multi-subunit Complexes—Protein, Nucleotide, Ligand

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    Fusion Proteins

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    Enzyme Replacement Therapies

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    ADCs and Protein Conjugates

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    PEGylated Proteins

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    Biosimilars

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    Vaccines, Including Subunit/Recombinant

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Complete Product Characterization

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Product and Process Development

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Manufacturing and QC

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Biosimilar Program Support

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Clinical Sample In Vivo CQA Mapping

Gene and Cell Therapeutic Analytics

ProtaGene has led the industry in developing vector analytics advancing gene therapy safety, gene expression analysis, integration site analysis, genetic analytics, and related bioinformatics solutions.

Gene & Cell Therapeutic Platform Expertise

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    Capsid-based Vectors

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    Complex, Envelope Vectors

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    Non-viral Vectors

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    Genetic Engineering

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Vector Analytics

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Gene Expression Analysis

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GeneWerk Integration Site Analysis

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Genetic Analytics

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Bioinformatics

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Our 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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Enhanced Partnerships Offer Strategic Expertise

Perhaps you need support to overcome a specific challenge, or maybe you’re looking for a close partnership throughout your product’s entire life cycle. ProtaGene’s CMC experts are here to help.

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Talk to Our Experts

Whether you are looking to learn more about our platforms or get a project started, contact our team today to discover how ProtaGene can support your development programs.

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