Cell Microarray data in regulatory submissions

Data from Retrogenix’s IND-enabling specificity studies have been included in numerous regulatory applications, often instead of tissue cross reactivity studies. In order to help understand the wider impact of Retrogenix specificity assessment, and to quantify the extent to which it is replacing other IND-enabling methods, such as tissue cross reactivity (TCR) screening, we have initiated a feedback process which allows us to collate and share data on how recently screened biotherapeutics are progressing. We surveyed pharma, biotech and non-profit sponsors who had undertaken at least one specificity screening project with Retrogenix since mid 2018. The results showed that:

  • Retrogenix screening data have been used in at least 75 regulatory IND submissions. Notably, Retrogenix’s specificity screening data were also included in the licensing application for Novartis’ Kymriah (tisagenlecleucel) which, in 2017, was the first CAR T immunotherapy to receive FDA approval.
  • Retrogenix data is accepted globally; with submissions to the US FDA, EMA (Europe), PMDA (Japan) and NMPA (China).
  • No tissue cross reactivity studies had been performed, in over a third of these submissions (38%) . The data for specificity assessment came solely from Retrogenix studies.
  • 90% of submissions using Retrogenix data have been approved to date*.

*last survey mid-2020

Further details of how our IND-enabling specificity data are being accepted by global regulators can be found by following the link below.

See full survey results

 

Retrogenix’s high rates of success in target deconvolution, receptor identification and off-target screening are due to:

High Success Rates
Physiological
Relevance
Expression in human cells results in correct folding and plasma membrane localisation and allows for multimerisation and the detection of interactions mediated by post-translational modifications such as glycosylation.
Broad
Coverage
At >5,500 full-length clones, our microarrays represent around 80% of 'high confidence' plasma membrane and secreted proteins providing the highest likelihood of identifying a ligand’s specific target.
Full-length
Proteins
Full-length, non-fused human proteins are expressed in human cells – a real advantage over traditional protein arrays.
Rapid
Turnaround
Results delivered in as little as 3 weeks.
Expertise &
Collaborative
Focus
Studies are co-designed with clients in order match their needs. Dialogue is maintained throughout and a comprehensive report with data interpretation delivered on completion.
Sensitivity
Specificity
Ligand-receptor interactions around 10 micromolar can be detected even without any amplification strategies. Reproducibility is key, resulting in the detection of specific, biologically-relevant targets.
Direct
Binding
As the Retrogenix technology detects direct binding of drug to proteins, and is not a competition-based assay, we can discover important allosteric interactions.
Versatility
Compatible with a range of detection methods including anti-His, anti-Flag, anti-V5, anti-Fc, biotin-streptavidin, directly fluorescently tagged and radiolabeled molecules.

Case Studies

Retrogenix’s results are now supporting patent applications, appearing in peer-reviewed publications and being presented at international conferences.

Find out about how the Retrogenix Technology has been used:

Case Studies

 

FAQ: “What data will I receive?”

A full report presenting and interpreting the results of the screens is provided at the end of the study. On request, members of the Retrogenix team can also present and discuss the results via a web meeting.

More FAQs

Talk to us about a project

    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
    Simcere logo
    Aveo Oncology - The Human Response
    Theraclone Sciences
    BioInvent
    AstraZeneca
    Bluebird Bio
    glycotope_logo
    The Center for Infectious Disease Research
    Compugen Logo
    Sanofi Logo
    The University of Copenhagen
    Lund University
    MedImmune
    NIH - National Institutes of Health
    The University of Pennsylvania
    Scripps Florida - The Scripps Research Institute
    Peptinnovate Ltd - Unlocking Nature's Potential
    The University of Sheffield
    Capella Bioscience Logo
    Unum Theraputics Logo
    Celyad Logo
    Genmab Logo
    Molecular Partners Logo