CORALVILLE, Iowa and FARGO, N.D. (Sept. 14, 2023)—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.
Orders for new CRISPR enzymes can be placed at www.idtdna.com/AldevronCRISPRnucleases.
“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.
For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. Through its GMP* services, IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.
Seeking to fulfill its mission of accelerating the pace of genomics, IDT acquired Archer™ NGS Research Assays in December 2022. When combined with its existing solutions, the expanded portfolio helps realize the shared vision of enabling researchers to rapidly move from the lab to life-changing advances.
IDT’s infrastructure supports customers around the globe with its manufacturing headquarters situated in Coralville, Iowa, USA, with additional manufacturing sites in San Diego, California, USA; Boulder, Colorado, USA; Research Triangle Park, North Carolina, USA; Ann Arbor, Michigan, USA; Leuven, Belgium; and Singapore. For more information, visit www.idtdna.com and follow the company on Twitter, LinkedIn, Facebook, YouTube, and Instagram.
RUO — For research use only. Not for use in diagnostic procedures. Unless otherwise agreed to in writing, IDT does not intend these products to be used in clinical applications and does not warrant their fitness or suitability for any clinical diagnostic use.
*GMP refers to products manufactured under ISO 13485: 2016 QMS. Purchaser is solely responsible for all decisions regarding the use of these products and any associated regulatory or legal obligations for their legal marketing.
Aldevron is a premier manufacturing partner, producing high-quality plasmid DNA, mRNA, proteins, and other key components for the development of vaccines, gene and cell therapies, immunotherapies and molecular diagnostics. Headquartered in Fargo, North Dakota, with additional locations in Madison, Wisconsin, and Lincoln, Nebraska, Aldevron supports scientists who are developing revolutionary, lifesaving treatments for millions of people. To learn more about how Aldevron is advancing biological science, visit www.aldevron.com.