HEK293 residual DNA testing in cell and gene therapy

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

Sponsor

HEK293 residual DNA testing in cell and gene therapy

Cell and gene therapies rely on host cell lines during their development. However, before administering the final product to a patient, it is crucial to remove any traces of host cell DNA to prevent toxicity including potential oncogenic effects.

This panel discussion-based webinar will explore the rationale and regulatory requirements behind HEK293-derived residual DNA detection and removal, and explain the relative pros and cons of the various analytical tools available, including both conventional and novel methods for residual host cell DNA measurement. In doing so, the panel will deliver a blueprint for success in meeting the requirements of key global regulatory bodies, including the US FDA, thus ensuring patient safety.

Attend this webinar to learn about:

The impact of HEK293 residual DNA contamination
Regulatory requirements relating to residual host cell DNA measurement
The limitations of traditional molecular detection methods and how to improve upon their sensitivity and accuracy

Adrien Savy

AAV Principal Scientist at Coave Therapeutics

Adrien has been working in the CGT industry over the last decade, including during his PhD at Généthon/Paris Saclay University. He has worked across Europe (France, UK, Germany) to develop and implement novel AAV production systems and analytics, with a strong focus on yield, quality, and potency, with several publications on these subjects.

As AAV Principal Scientist at Coave Therapeutics, Adrien is in charge of developing new analytical tools to study AAV and ligand conjugated vectors.

Dipika Gurnani

Global Product Manager, Digital Biology Group at Bio-Rad Laboratories

Dipika is the Global Product Manager of Droplet Digital PCR (ddPCR) Biopharma Solutions at Bio-Rad Laboratories. She is an advocate for advancing gene therapy and improving patient outcomes. With a focus on rare diseases that have historically lacked effective diagnosis and treatment options, Dipika ensures that Bio-Rad’s contamination testing products contribute to the development of safe and efficacious therapies. Her expertise lies in addressing critical challenges related to various contaminants in cell and gene therapy workflows. Dipika’s commitment to safety and innovation drives her work in transforming contamination testing using the latest Droplet Digital PCR (ddPCR) technology and kits. Dipika holds a Bachelor's in Biotechnology Engineering and Master's in Biological Sciences.

Tony Bou Kheir

Head of Analytical Development & QC at Purespring Therapeutics

Tony is currently serving as the Head of Analytical Development and QC at Purespring Therapeutics since 2022. Prior to this, he held positions at Cell and Gene Therapy Catapult and Barts Cancer Institute. Tony completed his Bachelor of Science degree in Biology/Biological Sciences, General from Saint Joseph University of Beirut, a MSc in Biochemistry and Molecular Biology, and finally obtained his PhD from the Universty of Copenhagen, specializing in the field of Epigenetics - microRNAs. He also held post-doctoral research positions at Imperial College London and Biotech Research & Innovation Centre (BRIC), University of Copenhagen.