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FIDA-Tech

Flow Induced Dispersion Analysis

FIDA Analyzer is a versatile automated instrument offering rapid, precise information on binding and concentration of proteins, antibodies and other biomolecules related to the development of biopharmaceutical drugs.

  • FIDA TECHNOLOGY
    Direct detection and quantification of proteins under native conditions
  • APPLICATIONS
    Mitigate immunogenicity with fast development of specific assays
  • RESEARCH FOCUS
    Faster drug development – higher safety – better efficacy
  • PRODUCTS
    Easy protocols – results in 5 min. – built-in quality control
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Features

The technology is linked to the well-known Taylor Dispersion Analysis theory applied to hydrodynamic flow in thin capillaries. Whether seeking accurate characterisation of DMPK properties based on standardised assays or in need of specific, valid information regarding immunogenicity, FIDA offers unmatched reliability and agility. Contrary to most other procedures, the FIDA methodology is based on binding in homogenous solution; complications related to non-specific surface adsorption and challenging assay development is therefore avoided. The unique features of FIDA Analyser enable characterisation and quantification in native (biorelevant) environments and in-built assay quality control and walk away automation as standard.

Flow Induced Dispersion Analysis (FIDA) is a new proprietary technology developed for quantification and characterization of proteins (including biologics), early detection of immune responses (including immunogenicity testing) and affinity assessment. FIDA is characterized by being fast (minutes), requiring very small sample amounts (nL-mL), and being exceptionally tolerant to the sample matrix. Contrary to most other procedures, the FIDA methodology is based on binding in homogenous solution; complications related to non-specific surface adsorption and challenging assay development is therefore avoided.   The unique features of FIDA enable characterization and quantification in native (biorelevant) environments and in-built assay quality control and automation.

Detection in native conditions

FIDA provides a high tolerance to matrix effects. When the relevant assay has been identified, it can typically be applied across different sample matrixes for example 100% plasma or serum. FIDA is based on direct detection in solution. The technology is essentially calibration free and there is no need for fixation of ligands (such as anti- gens) to a solid surface. In most cases, the analysis is a one-step procedure where the relevant ligand (termed the indicator) is mixed with the sample as part of the loading of the sample on to the instrument. Within a few minutes it is detected, if the analyte of interest is present in the sample and if so in what quantities.

Built-in quality control - high level of robustness

In addition to providing affinities and concentrations of proteins the FIDA technology also gives info on the abso- lute amount of ligand (indicator molecule) and size of complex. These parameters are used for internal quality control as they provide information on possible im- munecomplex precipitation, formation of aggregates or non-specific adsorption to the capillary wall.

Sensitivity

  • Quantification of proteins/biopharmaceuticals is possi- ble from the high pM to mM region
  • Dissociation constants are quantified in the range: pM - mM
  • Sizes of affinity complexes quantified from 1 - 300nm. Larger aggregates can be detected qualitatively

Fast assay development - optimal for immunogenicity testing

The simplicity of the methodology makes assays development truly easy. The main requirement is the availability of a ligand (indicator molecule), which binds to the analyte with high affinity and specificity. Such indicator molecules will often be available as antibodies (or antibody fragments). FIDA is particular well-suited for detecting immune responses as it is only probing a single binding event in solution. The development time (hours to days) of most new assays can be reduced by more than a factor of 2 compared to other platforms.

Ability to work with small sample volumes and recovery of sample

Thanks to the thin capillaries used to conduct the FIDA assay, the total sample volume consumption is a few nL to 3μL. In practice the sample is dis- pensed in a 96 well plate or vials, but the remaining sample can be used for other analysis.

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FIDA-Tech

CSL Behring adopts FIDA for accurate characterization of molecular interactions based on direct, in- solution measurements

“In benchmarking tests, FIDA has enabled CSL Behring to assess protein binding in solution with results comparable to current in-house technologies based on surface coupling of one binding partner. We are looking forward to using FIDA for the molecular interaction characterization of our innovative plasma-derived drug candidates.”

Giuseppina Fascellaro, Ph.D., Research Scientist, CSL Behring, Bern

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