2024 - Accelerating Cell and Gene Therapy Success with cGMP Gene Editing Components and Regulatory Compliance

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.
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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.
Keywords: cGMP, Gene Therapy, GMP, Gene Editing, Clinical Research, CRO, Cell Therapy, Commercial Manufacturing, Cell and Gene Therapies, Pre-Clinical, Cell & Gene Therapies, Quality