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IVD mAb

STANDARDS

Make your transition to the new EU regulation a success

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Complete and personalized support

100% personalized support

Thanks to our extensive expertise and capacity, we have developed an offer to help IVD actors to comply with the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) requirements by developing an efficient and robust alternative to disease-state plasma for your IVD standards.

  • Full support for a successful transition
  • Complete DSP characterization (polyspecific qualification, heterologous and homologous inhibition)
  • Custom mAbs with tailored services (design, production and storage)
  • Go/NoGo model

A UNIQUE AND PATENTED PLATFORM

built upon 15 years’ expertise

Bcell Design’s platform is based on patented genetically modified mouse models secreting human chimeric antibodies.
Through this platform, IVD developers and manufacturers gain access to a wide range of monoclonal antibodies that are immediately ready for testing in human models.

  • Only one human isotype per mouse line (no other isotype)
  • Human FC
  • The mouse’s complete immune repertoire is maintained
  • The normal VDJ recombination and hypermutation pathway are maintained

Advantages of IVD mAb standards

Our IVD mAb standards (IgG, IgM and IgA) are used for positive controls, calibrators and quality controls.

Advantage 1 - quality

High-quality products: sensitivity, specificity, selectivity

Advantage 2 -Perfect batch-to-batch reproducibility

Perfect batch-to-batch reproducibility

Ready to use

Contact us

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98 rue Charles Le Gendre – 87000 Limoges – FRANCE
contact@b-cell-design.com