SPR for CRO Bioanalytical Testing

AT BIOPTIX BIOSENSORS ARE ALL WE DO.

With more than 30 years combined expertise in the field of SPR, the BiOptix team is totally focused on your success and research productivity with an affordable alternative to traditional SPR instruments.

Customer-Focused Approach

  • Rapid response to technical requests
  • Protocol development and assay troubleshooting assistance
  • 24 hour call back response time for instrument service

 

POWERFUL COMBINATION: SPR + INTERFEROMETRY

The BiOptix 404pi™ combines the power of Surface Plasmon Resonance (SPR) with interferometry creating a unique and precise detection method called Enhanced SPR. We offer an affordable and powerful solution for drug discovery scientists that require label-free, real time detection of biomolecular interactions.

  • Precise measurement of kinetic rate constants, affinity constants and active concentration analysis
  • Intuitive, user-friendly instrument control software
  • Reveals information on kinetics, dissociation and stability of molecular interactions that conventional endpoint analysis doesn’t deliver

 

THE BIOPTIX 404PI IS THE IDEAL TOOL FOR BOTH SCREENING AND CHARACTERIZATION OF ANTIBODIES, PROTEINS, SMALL MOLECULES, FRAGMENTS AND BIOSIMILARS.

 

IMMUNOGENICITY SCREENING

The induction of anti-drug antibodies (ADA) in patients is a major concern in the development of biological therapeutics. Detecting and quantifying ADAs is of great importance to the pharmaceutical industry because any immune response against a therapeutic can affect the safety, pharmacokinetic profile and efficacy of the drug.

The FDA strongly recommends the implementation of immunogenicity assays that detect, quantitate and characterize ADAs. Using biosensors to detect ADA is important because they can detect low affinity anti-drug antibodies (ADA) that ELISA or MSD (Meso Scale Discovery) assays may miss.

ROBUST FLUIDICS DESIGN AND DETECTION CAPABILITIES IN COMPLEX SOLUTIONS

  • Reliable Microfluidics Cartridge
    • Supports the use of high concentrations of human serum
    • No clogging – handles complex mixtures
    • Increased uptime – no replacement needed
  • Rapid Screening & Detection
    • Screens 130 samples in 14 hours
    • 4×1 mode screens 4x faster
    • Detects weakly binding ADA in initial immune response
    • Easily determines subclasses and isotypes of antibodies
    • Allows for quantitative measurements of antibody dissociation rates

BIOSIMILAR DEVELOPMENT

According to the FDA Guidance on Demonstrating Biosimilarity to a Reference Product (April 2015), “Rigorous structural and functional comparisons that show minimal or no difference between the proposed product and the reference product will strengthen the scientific justification for a selective and targeted approach to animal and/or clinical testing to support a demonstration of biosimilarity… in vitro assays may include biological assays, binding assays and enzyme kinetics”.

The 404pi will help you demonstrate:

  • Similar binding kinetics to the original biologic product
  • Equivalent binding affinity to FcɣR and FcRn
  • Equivalent stoichiometry of binding
  • The amount of active material
  • Equal or lower immunogenicity

Confirmatory Immunogenicity Screen

FRAGMENT-BASED SCREENING

A significant trend in small molecule drug discovery is the growth in fragment-based screening. Many pharmaceutical and biotech companies need to cover more “chemical space” to develop new drugs and find that fragment-based screening is an excellent tool. SPR is one of the top techniques for screening fragment libraries that typically range in size from 100 Da to 300 Da.

The BiOptix 404pi:

  • Accurately and reliably measures binding of low MW compounds (down to 95 Da)
  • Screens up to 330 fragments/day

 

EXPERIMENTAL FLEXIBILITY

With two injection modes, the 404pi allows for flexibility in experimental design. 4×1 mode, where four samples can be injected simultaneously over four flow cells, enables 4x the throughput of serial flow cell biosensors. 2×2 mode is used for generating high quality, double referenced data for kinetic analysis.

 

ACTIVE CONCENTRATION ANALYSIS

The BiOptix 404pi can give the concentration of active protein rather than total protein obtained by absorbance.

  • Important during protein production and assay development
  • Can be quicker and easier than ELISA

Unique flow cell architecture of the BiOptix 404pi

  • Concentration analysis
  • Regeneration screening
  • Immunogenicity screening
  • Kinetic analysis
  • 2 independent interactions
  • Decreased assay development time

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