Biologic Drug Analytics

Manufacturing and QC

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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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