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GenCRISPR cGMP gRNA

GenScriptcGMP CRISPR, cGMP sgAvailable: Worldwide

Confidently transition your CRIPSR-based cell or gene therapy from bench to clinic with cGMP (current Good Manufacturing Practice) gRNA.

GenScript

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Description

Produced in our state-of-the-art cGMP (current Good Manufacturing Practices) facility, our cGMP guide RNA manufacturing services meet the rigorous requirements for global IND submissions. We offer scalable production from 30 mg to gram-level quantities per batch, backed by comprehensive documentation and regulatory compliance with FDA, EMA, PMDA, and NMPA guidelines. With over 120 cGMP batches of CRISPR reagents delivered and 13 IND approvals supported, we are a trusted partner for your clinical needs.

Start your cGMP gRNA production today with no waiting time—contact us now to get started.

White PapersLife Sciences

Navigating the regulatory path of CRISPR-based therapeutics

Unlocking the full potential of CRISPR-based therapeutics calls for technical innovation, strict compliance with regulatory standards, and ongoing collaboration with regulatory bodies. While developing treatments for genetic and rare diseases can be time-consuming, engaging with the FDA's Expedited Programs can streamline the process. Recent signals from the FDA's Center for Biologics Evaluation and Research suggest a growing preference for Accelerated Approval for gene therapies, underscoring the agency's commitment to expediting access to crucial treatments for rare conditions. GenScript offers invaluable guidance for navigating the intricate regulatory landscape of cell and gene therapies, empowering stakeholders to chart a course for success.

De-risk your CRISPR pipeline with scalable cGMP guide RNA

Tuesday, April 8, 2025 – 16:00 BST / 17:00 CEST / 11:00 EDT / 08:00 PDT

Join us for an exclusive webinar with Dr. Pedro Teh as he explores how expert guide RNA (gRNA) manufacturing services can help accelerate your CRISPR-based therapeutic development in line with current good manufacturing practices (cGMP).

As a trusted partner in cell and gene therapy, GenScript provides high-quality, scalable, and regulatory-compliant gRNA for CRISPR systems including Cas9, Cas12a, prime editing, and base editing.

Discover how GenScript's cGMP synthesis capabilities and state-of-the-art production facility ensures a streamlined 30-day turnaround for clinical-grade gRNA, and see how comprehensive documentation support – including Drug Master Files (DMFs) – can facilitate smooth investigational new drug (IND) submissions and regulatory approvals.

Whether you're in early-stage research or preparing for clinical trials, this webinar will show you how GenScript's expertise in cGMP nucleic acid manufacturing, quality control, and regulatory support can help de-risk and accelerate your CRISPR therapeutic pipeline.

Key learning objectives:

  • Learn about cGMP guide RNA manufacturing and quality control processes
  • Explore a range of gene editing approaches that can be supported by cGMP gRNA services
  • Understand how expert documentation support simplifies IND submissions and regulatory approvals
  • Learn why procuring RUO to cGMP gRNA from a single vendor streamlines and de-risks the development process for CRISPR therapies

Who should attend?

Scientists and decision-makers from biopharma, biotech, and academic institutions using gene editing for discovery or preclinical research.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.

If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.

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