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The Age of Cell and Gene Therapies is Upon Us – What Does it Mean for Bioanalysis?

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As of March 2022, there are 20 US Food and Drug Administration (FDA) approved cell and gene therapy (CGT) licensed products from the Office of Tissues and Advanced Therapies (OTAT) and according to clinicaltrials.gov over 2,000 active CGT clinical trials.


TORONTO (PRWEB)

Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a disorder. Often it can be a combination of cell and gene therapies, which is the case for chimeric antigen receptor T (CAR T) cells. As of March 2022, there are 20 US Food and Drug Administration (FDA) approved cell and gene therapy (CGT) licensed products from the Office of Tissues and Advanced Therapies (OTAT) and according to clinicaltrials.gov over 2,000 active CGT clinical trials.

But what does it mean for bioanalysis? In this webinar, the featured speakers explore the challenges with bioanalytical method development and qualification/validation for support of CGTs. They will take a deep dive into the following bioanalytical assays and the platforms to support them:

Pharmacokinetics (PK) — quantitative PCR (qPCR), digital droplet PCR (ddPCR), flow cytometry, ligand binding assays (LBAs); Biodistribution — qPCR, ddPCR, flow cytometry, LBAs; Immunogenicity — LBAs, flow cytometry cell-based assays (neutralizing antibody) against transgene, viral vectors, etc; Pharmacodynamic markers — qPCR, ddPCR, flow cytometry, enzyme-linked immunosorbent spot (ELISpot) assay, LBAs; And viral shedding (outcomes and safety) — ddPCR, qPCR, cell-based infectivity assays.

Additionally, the speakers will discuss how the demand for GLP bioanalytical analysis for support of CGTs has exploded.

Join this webinar to explore what the advent of cell and gene therapies mean for bioanalysis.

Join experts from KCAS Bioanalytical and Biomarker Services, Dominic Warrino, Senior Scientific Advisor; and Jeff Hester, PhD, Senior Director, Cell & Gene Therapy Services, for the live webinar on Friday, June 24, 2022, at 12pm EDT (5pm BST/UK).

For more information, or to register for this event, visit The Age of Cell and Gene Therapies is Upon Us! What Does it Mean for Bioanalysis?

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