Integrated DNA Technologies (IDT), a global genomics solutions provider, a segment of Danaher Corp., completed its new therapeutic oligonucleotide manufacturing facility in Coralville, IA. The milestone marks its entrance into the therapeutics space and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with services from the lab to therapeutic development.

The 41,000-sq.-ft.-site 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.

The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity, and air pressure throughout, supported by an environmental program and continuous monitoring system.

“An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “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 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 research use only to cGMP, and enables us to help more people.”