Biologic Drug Analytics

Product Characterization & Attribute Analysis

Product Characterization & Attribute Analysis

With more than 20 years of working in complex biologic drug characterization, we have extensive experience developing and establishing protein characterization methods.

According to the ICH Q6B guideline, the analytical characterization includes primary, secondary and higher order structural assessment, the biological activity and the analysis of product and process impurities.

We help our clients generate the data needed for product characterization from candidate selection through regulatory submission and commercial product QC testing.

Complete IND/IMPD and BLA/MAA phase-appropriate characterization including:

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    Primary sequence and PTM analysis

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    Intact and subunit analysis

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    Disulfide linkage mapping

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    Glycosylation characterization

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    Forced degradation and low-level Impurity ID programs

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    Host cell protein analysis/ELISA correlation by LC-MS

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    Hydrogen deuterium exchange (HDX-MS)

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    PEGylation and ADC DAR mapping

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    Amino acid analysis/extinction coefficient determination

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    Protein binding by SPR/Biacore

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    Higher-order structure (HOS) characterization by AUC, CD, FTIR

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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