Biologic Drug Analytics

Manufacturing and QC

Biologics 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 strategies, state-of-the-art analytic platforms run under GMP quality systems, and specialized expertise across both Europe and the US to help advance your manufacturing and product-facing analytical programs such as:

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    Manufacturing and Process Analytics

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    Method Development

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    Phase Appropriate Validation

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    QC-lot Release

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    Stability Program Management

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    Analytical Life Cycle Management

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    Host Cell Protein Analysis

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

Biologic Therapeutics Platform Expertise

Our deep experience advancing a diverse range of therapeutic platforms from research through market help the ProtaGene team design highly effective analytical programs that de-risk development and accelerate timelines to your next key milestones. Key biologic development areas include:

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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

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    Biosimilars

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    Vaccines, including subunit/recombinant

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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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