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.

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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.

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Speaker

Dr. Jianpeng Wang, Senior Director of GMP Manufacturing, GenScript

Dr. Jianpeng Wang is the Senior Director of GMP Manufacturing at GenScript and a seasoned professional with a PhD in Chemistry and more than 15 years of experience in early R&D, process development and GMP manufacturing of nucleic acids for gene editing. Under his leadership, Dr. Wang’s matrix team has delivered more than 100 batches of cGMP products to support over 40 projects globally.

Specializing in the adoption and implementation of a phase-appropriate quality management system to ensure product quality and regulatory compliance, his thorough understanding of nucleic acid products and the dynamic regulatory landscape plays a pivotal role in ensuring GenScript meets and exceeds the needs of customers developing innovative therapies around the globe.

Message Presenter

Who Should Attend?

This webinar will appeal to academic and industry professionals in biotechnology and biopharmaceutical organizations involved in GCT therapy development or the following:

Research Scientists and Product Development Managers
Quality Assurance Specialists
Professionals in regulatory affairs
Academic researchers and clinicians interested in translating their discoveries into clinical applications
Executives and decision-makers considering gene editing component services for preclinical and clinical studies

What You Will Learn

Attendees will learn about:

The distinctions between RUO, preclinical and clinical grade (under cGMP) gene editing components
Case studies on the challenges of off-target insertions and degradation, and the development of strategies to mitigate these issues in CGT development
How manufacturing capabilities, analytical services and regulatory support help in making successful IND submissions
How the use of phase-appropriate components can optimize clinical outcomes cost-effectively

Xtalks Partner

GenScript

GenScript is the leading contract research organization in the world providing gene, peptide, protein, CRISPR, and antibody. Since its foundation in 2002, GenScript has grown exponentially through partnerships with scientists conducting fundamental life science research, translational biomedical research, and early stage pharmaceutical development. The company is recognized as having built a best-in-class capacity and capability for biological research services, encompassing gene synthesis, peptide synthesis, custom antibody and protein engineering, and in vitro and in vivo pharmacology – all with the goal to Make Research Easy.

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

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