Integrated DNA Technologies and Aldevron inked a new global distribution agreement to expand key CRISPR solutions for cell and gene therapy customers. 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.

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. A Drug Master File (DMF) is on file with the U.S. FDA to streamline regulatory filings. 

• 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 R&D 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. A DMF is on file with the U.S. FDA.

“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, vice president, general manager, gene writing and wditing & 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.”

Tom Foti, vice president and general manager of Aldevron’s Protein Business Unit said, “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. By combining manufacturing strengths, from day one, IDT clients now can access Aldevron CRISPR proteins which are designed for clinical translation.”