Biologic Drug Analytics

Analytical Excellence for Biologics

ProtaGene is a CRO with extensive expertise in advanced method development, early to late-stage characterization, GMP product testing, and full analytical packages for product lifecycle management.

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We’re well-staffed and positioned to support your established QC and high-volume programs and take on your most complex characterizations and method development programs.

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Comprehensive Analytical Solutions from Research to Market

We offer comprehensive capabilities and expertise to support every phase of a biologic’s lifecycle.

Complete Product Characterization Created with Sketch.

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

Clinical Sample In Vivo CQA Mapping Created with Sketch.

Clinical Sample In Vivo CQA Mapping

Diverse Biologic Therapeutics Platform Expertise

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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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    mAbs

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    ADCs and Protein Conjugates

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    PEGylated Proteins

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    Bispecifics/Multispecifics

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    Fusion Proteins

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    Enzyme Replacement Therapies

Why ProtaGene?

We collaborate with you to design a program customized for your molecule and the demands of your development timeline.
  • Unique development expertise in both protein and gene analytics
  • Broad single-vendor analytical offering from discovery to market
  • Significant scale of expertise & multi-region facility presence
  • Best-in-class quality supporting robust regulatory packages
  • Reputation and delivery trusted by leading biopharma companies
Learn More About ProtaGene

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

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