Leading CRISPR gene editing companies Integrated DNA Technologies and Aldevron inked a new global distribution agreement to expand key CRISPR solutions for cell and gene therapy customers. Effective today, IDT will stock and sell three additional research use only (RUO) and current good manufacturing practice (cGMP) CRISPR nucleases with unique performance characteristics, manufactured by Aldevron, to provide researchers with an accelerated path to the clinic.

“IDT and Aldevron are united in accelerating CRISPR research worldwide by working together to deliver key solutions for translational medicine, increasing our shared value to the entire CRISPR community,” said Sandy Ottensmann, VP/GM, Gene Writing and Editing & Core/PCR Business Units at IDT. “Expanding access to best-in-class gene editing reagents and tools to enable customers to rapidly innovate and translate their projects from research breakthroughs to potential life-saving treatments is key to advancing the future of genomic medicine, and we’re proud to work alongside Aldevron to realize this important work.”

“Successful clinical translation requires high quality reagents and consistent performance from proof-of-concept through patient dosing. We are thrilled to partner with IDT and bring together their expertise in CRISPR chemistry and oligo production with Aldevron expertise in cGMP CRISPR nuclease and ribonucleoprotein (RNP) manufacturing,” said Tom Foti, Vice President and General Manager of Aldevron’s Protein Business Unit. “By combining manufacturing strengths, from day one, IDT clients now can access Aldevron CRISPR proteins which are designed for clinical translation.”

Customers investigating genetic and inherited diseases can now purchase both research grade and full cGMP CRISPR nucleases from IDT. cGMP products accelerate researchers’ path to the clinic by including cGMP quality documentation required for regulatory filings.

The following Aldevron-manufactured enzymes, engineered to be used in a variety of applications including electroporation, transfection, and microinjection, are now available through IDT:

• SpyFi® Cas9 Nuclease—designed for greater editing efficiency and reduced off-target effects. When used in conjunction with an effective guide RNA, target site, and double-stranded DNA cut strategies, this can deliver higher-fidelity editing with less off-target activity than wild-type SpCas9 nuclease. A Drug Master File (DMF) is on file with the U.S. Food and Drug Administration to streamline regulatory filings. Aldevron’s SpyFi Cas9 Nuclease is sold under license of patents and/or patents pending from IDT.
• Eureca-V™ Nuclease—a Class 2, Type V nuclease based on novel MAD7® protein licensed from Inscripta® that targets a T-rich PAM domain and creates a staggered double-strand break at the target locus. This enzyme supports research and development in the allogeneic cell therapy space.
• SpCas9 Nuclease—a wildtype SpCas9 nuclease for use in development work as well as standard cGMP products for clinical studies. SpCas9 is supported by an extensive QC panel at research grade and GMP product levels. A Drug Master File (DMF) is on file with the U.S. Food and Drug Administration to streamline regulatory filings.