GenCRISPR cGMP HDR Knock-in Templates
Advance to IND filing and clinical trials faster and more efficiently with cGMP (current Good Manufacturing Practice) HDR Knock-in Templates, available in three versatile formats.
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Manufactured in our state-of-the-art cGMP production facility, with the processes and comprehensive documentation required for global IND filing, up 100 mg/batch for our linear ssDNA and gram level/batch for our linear and circular dsDNA formats. Compliant with FDA/EMA/PMDA/NMPA regulations, our cGMP DNA payloads leverage our decades of leadership in providing long and complex DNA sequences.
Contact us now to start your cGMP ssDNA or dsDNA production with no waiting time.
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.
