A framework for genomic integrity testing across the development lifecycle

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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A framework for genomic integrity testing across the development lifecycle

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Genomic integrity is a critical focus in cell and gene therapy (CGT) development, as structural changes to the genome that arise during editing can lead to serious consequences like oncogenesis or clonal outgrowth. Regulatory agencies now emphasize the importance of assessing genomic integrity as part of the development process, with structural variant analysis increasingly being used across all development stages. Traditional cytogenetic tools like G-banding have limitations in detecting rare or complex events. Advanced cytogenetic tools that analyze hundreds of single cells can provide a more complete picture of genome stability, allowing detection of both rare and prevalent structural variants with greater confidence.

In this webinar, case studies will illustrate practical application of genomic integrity testing. The presentation includes an example involving CD33 CAR-NK cell therapy for AML. Structural variant testing was used to confirm transgene insertion accuracy, rule out off-target effects, and support the release of cells for patient use, highlighting how this type of testing informs both product safety and manufacturing quality.

Learn how to integrate genomic integrity analysis—including chromosomal rearrangements, insertions, and transgene mapping into your QC workflows to meet evolving FDA guidance for CGTs
Understand how detecting rare structural variants at the single-cell level can identify risks like clonal proliferation or insertional mutagenesis before they reach the clinic, to build safer, more robust therapeutic products
Explore how cutting-edge cytogenetic tools, like those demonstrated in the AML CAR-NK case study, are setting new benchmarks for structural variant detection across therapy types and development phases

Prithy Martis

Operations Manager of the Biologics Manufacturing Resource at Nationwide Children’s Hospital

Prithy Martis, PhD, is the operations manager of the Biologics Manufacturing Resource at Nationwide Children’s Hospital (NCH). Dr. Martis earned her bachelor’s degree in biochemistry from Case Western Reserve University. She obtained her doctorate degree from Wright State University where she focused on understanding the mechanism of action of an encapsulated cell therapy for treatment-resistant colorectal and prostate cancers as part of a Phase II clinical trial. Prior to her work at NCH, Dr. Martis co-founded Cellentrex, a 3D in vitro model company providing alternatives to animal testing in the drug discovery process. As part of the Biologics Manufacturing Resource, Dr. Martis supports the clinical-grade manufacture of autologous and allogeneic cell therapies used for various indications including relapsed and refractory AML, ALL, and neuroblastomas, high risk AML, sarcomas, cardiac anomalies, and pancreatitis. These therapies support early-stage clinical trials through standard of care at over 25 hospitals nationally.

Erin Cross

Vice President of Platform at KROMATID

Erin Cross is the Vice President of Platform and the lead development scientist at KROMATID. As one of the company's first employees, she has been instrumental in pioneering KROMATID's flagship technology, directional Genomic Hybridization™ (dGH), which enables unbiased, single-cell assessments of genomic structural rearrangements. With over seventeen years of experience in molecular biology, virology, and genetics, Erin has played a key role in positioning KROMATID at the forefront of cytogenetic and cellular engineering research. She earned her Master of Science in Cell and Molecular Biology, with a focus on Viral Genetics, from Colorado State University in 2007.

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