Clinical Sample In Vivo CQA Mapping - ProtaGene

Biologic Drug Analytics

Clinical Sample In Vivo (CQA) Mapping

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Clinical Sample In Vivo Critical Quality Attribute (CQA) Mapping

ProtaGene’s advanced methods utilize specifically targeted drug extraction and preparation strategies, in conjunction with high-sensitivity LC-MS based structural characterizations of the biologic, to generate detailed quantitative PK assessments of drug levels in vivo (covering multiple peptides simultaneously) and highly precise profiling of the drug’s structural attributes, metabolites, and PTM’s.

All pre-clinical and clinical sample analysis and profiling are assessed through an entire PK time course directly from pre-clinical and/or clinical samples (serum, plasma, or other tissue types).

This correlation of a biologic drug’s structural attributes to patient exposure levels and performance in vivo may be used to define, optimize, and guide early-stage candidate selection, dosing levels into Phase I, later-stage bioproduction strategies and decisions, CMC and control packages, and potentially clinical trial designs and analysis. ProtaGene’s pre-clinical and clinical sample analysis capabilities include:

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    Pre-clinical/clinical Product Monitoring – quantitative assessments in pre-clinical and patient samples

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    Pre-clinical/clinical Product Monitoring—in vivo CQA assessments in pre-clinical and patient samples

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    Patient exposure to CQA for trial design and assessment

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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