Biologic Drug Analytics

Cell-based Assays

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ProtaGene offers state-of-the-art assays to evaluate the potency of your product for safety and efficacy.

Cell-based assays
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    Reporter Gen Assays (RGA)

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    Effector Function – Complement Dependent Cytotoxicity (CDC)/Antibody Dependent Cellular Cytotoxicity (ADCC)

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    Viability Assays

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    Checkpoint Inhibitors – e.g., PD-1/PD-L1

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    New molecule specific assays on request

Binding assays
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    SPR

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    ELISA

ProtaGene’s dedicated cell culture and cell-based assay team is built to support our partners with unique expertise and high capacity.

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    GMP-compliant structural characterization expertise to elucidate potential effects on your Molecule’s Potency (Structure-Function Correlation)

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    ProtaGene offers molecule-centered structural characterization with high-resolution mass spectrometry to evaluate effects on molecule potency

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    Utilization of bioluminescence-based read-outs enable robust signal detection

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    Establishment of thaw & use working cell banks will enable fast turnaround times

Centralized project management team to support your product at all project stages.

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    Highest flexibility in project planning and operations, including workflow adaptation, reporting, and alignment of QM-systems and validation parameters

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    Close collaboration with partner to discuss project results and analytical strategies

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    Internal and centralized project management as a single point of contact, including financial and operational topics

Featured White Paper

Content and Degradation of Polysorbates in Biopharmaceutical Formulations

We present orthogonal analytical procedures for quantification of the total polysorbate content, determination of polysorbate identity, as well as characterization and quantification of polysorbate degradation products. The methods presented here provide a powerful toolbox for the control of polysorbate quality and stability in polysorbate-formulated biopharmaceutical drug products as requested by health authorities.

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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