IND-enabling & Lead Selection Specificity Data for Biotherapeutics

Data from Retrogenix’s IND-enabling specificity studies have been included in numerous regulatory applications. Our data is accepted globally; with submissions to the US FDA, EMA (Europe), PMDA (Japan) and NMPA (China).

Across the board, for all submissions that used Retrogenix data, the acceptance rate was 90% with 7% of the applications still in the process of submission.

How can our cell microarray platform advance therapeutic development?

Retrogenix’s unique cell microarray technology provides a fast, accurate solution for discovering the human cell surface and secreted protein targets of antibodies, proteins, CAR-T cells, viruses, and small molecules.

Our unique tool uses proprietary arrays of expression vectors – encoding over 6,200 human plasma membrane, tethered secreted, and heterodimer proteins – spotted onto slides. Human cells grown over the top become reverse-transfected, resulting in cell surface expression of each respective protein at distinct slide locations. The test molecule is applied and specific binding analysed and confirmed using an appropriate detection system.

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Retrogenix provides key IND-enabling specificity data, with a growing interest amongst top biopharma companies as a replacement to tissue cross-reactivity studies, as well as generating data to aid lead selection discussions. Learn more:

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    I would like to thank you very much for the great and very timely work including this report which will be key data for our submission to the regulatory authorities.
    Marcel Walser, PhD, Senior Director Research, Molecular Partners
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    Aveo Oncology - The Human Response
    Theraclone Sciences
    Bluebird Bio
    The Center for Infectious Disease Research
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    The University of Copenhagen
    Lund University
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    The University of Pennsylvania
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