Biologic Drug Analytics

Biosimilar Program Support

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Biosimilar Program Support

For 20 years, ProtaGene has successfully supported pharma clients in developing over 25 different biosimilar molecules.

The quality requirements are critical for the development of biosimilars. These requirements are needed to generate evidence demonstrating the similar nature concerning the biosimilar product’s quality, safety, and efficacy to the innovator product.

Our biosimilarity programs evaluate structure and physiochemical properties, biological safety, purity, impurities, and stability. ProtaGene is highly experienced in performing comparability studies and in the analysis of biosimilar products in accordance with ICH Q6B and CHMP guidelines, including:

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    Sourcing commercial product

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    Establishment of QTPPs/CQAs

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    QTPP driven biosimilar development

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    Product characterization under development

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    Product similarity and impurity comparability program design and management

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    EU release testing

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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