In this free webinar, take a deep dive into the distinctions between research use only (RUO), preclinical and clinical grades and how these affect gene editing components in cell and gene therapy development. Review case studies on the challenges of off-target insertions and degradation, and the development of strategies to mitigate issues in cell and gene therapy development. Attendees will learn how manufacturing capabilities, analytical services and regulatory support help in making successful investigational new drug submissions. The featured speaker will also explore how the use of phase-appropriate components can ensure cost-effective clinical outcomes.
TORONTO, June 25, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar that focuses on the critical stages of gene editing component manufacturing for cell and gene therapy (CGT) development. The focus of this webinar is on the nuances of product quality, regulatory compliance and the distinct requirements for research use only, preclinical and clinical grade components.
The manufacturing of gene editing (GE) components such as single guide RNA (sgRNA) and homology-directed repair (HDR) knock-in templates is a pivotal aspect of GE-based CGT development, requiring meticulous attention to chemistry, manufacturing and controls (CMC; product quality) and regulatory compliance (quality management system) throughout the development lifecycle.
The manufacturing, quality control processes and associated documentation requirements for GE components vary significantly depending on the stage of development in which they are being used — be it research, preclinical studies or clinical trials.
The industry generally differentiates between research use only (RUO-Discovery), pre-clinical/investigational new drug enabling (INDe) and clinical grades for GE components. Procuring GE components across the full range of quality grades without delays or disruption is important to ensure a seamless transition from research to the clinic.
In this webinar, the expert speakers will explore key differences between GE components used from early discovery through to clinical application and share insights into how phase-appropriate components can be used to achieve clinical objectives while balancing quality and cost considerations. Attendees will be introduced to the critical differences in documentation and standards that distinguish RUO, INDe and clinical grades (under cGMP), and how these affect the development and eventual use of GE components in CGT development.
The webinar will also cover case studies and experimental data that address common challenges such as off-target insertions and the impact of component degradation and strategies that are implemented to reduce these concerns. The speakers will also cover the proprietary technologies, state-of-the-art manufacturing and QC facilities, analytical capabilities that are instrumental in characterizing CGT components and introduce the scientific and regulatory support available for investigational new drug (IND) submissions, which is crucial for the successful navigation of the complex pathway to clinical trials.
Register for this webinar today to explore the critical stages of gene editing component manufacturing for cell and gene therapy development.
Join Dr. Jianpeng Wang, Senior Director of GMP Manufacturing, GenScript for the live webinar on Friday, July 12, 2024, at 10am EDT (3pm BST/UK).
For more information, or to register for this event, visit Accelerating Cell and Gene Therapy Success with cGMP Gene Editing Components and Regulatory Compliance.
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