With these expanded capabilities, IDT is able to establish a bridge from the lab to therapeutic development by offering a complete workflow for CRISPR genome editing, RUO through cGMP solutions for cell and gene therapy.
The 41,000 square-foot facility will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic.
With these manufacturing and portfolio extensions in place, IDT is positioned to enable a seamless transition from early-stage research to clinical therapeutic application with the same innovation, quality, and support expected from a trusted 35-year leader.
Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of their therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from RUO to cGMP, and enables us to help more people.
IDT engineering runs and cGMP gRNA are for development and investigational use only. The performance characteristics of this product have not been established. This product is not intended to be used as final drug product. The purchaser is solely responsible for all decisions regarding the intended use of the product and any associated legal or regulatory obligations.