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
  • Reporter Gen Assays (RGA)
  • Effector Function – Complement Dependent Cytotoxicity (CDC)/Antibody Dependent Cellular Cytotoxicity (ADCC)
      • CDC: Does my mAb activate the complement system either on purpose (MoA) or as an unwanted side effect (safety & efficacy)?
      • Reporter ADCC: Does my mAb bind to FCRIIIa receptor either on purpose (MoA) or as an unwanted side effect (safety & efficacy)?
  • Viability Assays
      • Does my mAb initiate apoptosis in cells expressing the target antigen?
  • Checkpoint Inhibitors – e.g., PD-1/PD-L1
  • 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

A 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

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.

See Systems List
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