Integrated DNA Technologies opens new therapeutic manufacturing facility to support growing demand in genomic medicine

Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation, recently announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa.

The 41,000-square-foot 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 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, and shell space for future expansion. 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. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large-scale RUO, Engineering Run, and cGMP (ICH Q7).

“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, evolve IDT’s business model from Research Use Only to cGMP, and enable us to help more people.”

A decade of CRISPR innovation

Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow – from design to analysis – to enable greater quality, simplicity, and cost efficiency.