IDT’s Therapeutic Oligonucleotide Manufacturing Facility, Iowa, US

IDT’s therapeutic oligonucleotide manufacturing facility is located in Iowa, US. Credit: Dreamsenses Photography.

The new facility was developed to meet the needs of cell and gene therapy developers. Credit: Dreamsenses Photography.

The facility features ISO 8 cleanrooms, purification suites, and quality control labs. Credit: Dreamsenses Photography.

The new facility includes analytical lab space for product testing. Credit: Dreamsenses Photography.

Integrated DNA Technologies (IDT) opened its first therapeutic oligonucleotide manufacturing facility in Coralville, Iowa, US, in October 2023.

IDT is a genomics solutions provider and is part of the life sciences segment of Danaher, a biotechnology and diagnostics company based in the US.

The new facility supplies current good manufacturing practice (cGMP)-grade cell and gene therapy reagents including single guide RNA and donor oligos for homology-directed repair (HDR).

It serves as a single partner for cell and gene therapy developers to quickly transition from clinical development to commercialisation.

IDT’s therapeutic oligonucleotide manufacturing facility details

IDT’s therapeutic oligonucleotide manufacturing facility spans an area of 41,000ft². It features ISO 8 cleanrooms, purification suites, analytical labs for product testing, and quality control labs.

In addition, the facility includes chemical distribution and storage rooms, ancillary spaces, office rooms, and additional space for future expansion. It is integrated with a continuous monitoring system and environmental controls for temperature, humidity, and air pressure.

The manufacturing process at the facility complies with ICH Q7 cGMP standards to ensure reliable quality.

Services offered

The new facility bridges the gap between research use only (RUO) and cGMP services and enables IDT to provide additional services such as large-scale RUO and engineering runs.

The services are supplemented by other offerings such as complete documentation and testing, support services, and regulatory guidance to expedite the therapy development process for researchers.

In addition, the facility offers a comprehensive workflow for clustered regularly interspaced short palindromic repeats (CRISPR) genomic editing from the design to analysis stage, thereby providing customers with support in all stages of therapeutic development.

IDT’s CRISPR genome editing solutions

The CRISPR and Cas9 enzyme genome editing solutions help in performing genome modification in cells or organisms faster than other genome editing methods. The Alt-R CRISPR systems developed by IDT produce a double-stranded break that is essential for gene disruption and DNA insertion using homologous recombination.

The company’s proprietary CRISPR genome editing systems include Alt-R CRISPR-Cas9 and Alt-R CRISPR-Cas12a. The CRISPR-Cas9 system can be used for general genome editing while the CRISPR-Cas12a system helps in targeting additional genomic sites that are not available using the former system.

IDT also offers high-purity CRISPR nucleases for conducting genome editing experiments, apart from chemically synthesised custom guide RNAs and custom synthetic gRNA libraries for research applications.

The Alt-R genomic editing solutions also include HDR Donor Blocks, which are used for increasing HDR rates in experiments.

Other solutions include the rhAmpSeq CRISPR analysis system used for accurate quantification of genome editing and an Alt-R genome editing detection kit to determine the genome editing efficiency.

Contractors involved

The design and construction of the new facility was handled by M.A. Mortenson, a real estate developer, and a team comprising OPN Architects and Barr Engineering.

OPN Architects is an architectural, landscape, and interior design business while Barr Engineering is an engineering and environmental consultant.

Marketing commentary on IDT

Founded in 1987, IDT is a genomics solutions provider with key application areas such as next-generation sequencing, CRISPR genome editing and RNA interference, among others. It manufactures products for researching critical conditions such as cancer, genetic disorders, and infectious diseases.

IDT is headquartered in Coralville, Iowa, and has manufacturing sites in California, Colorado, North Carolina, and Michigan in the US, as well as in Belgium and Singapore. The company employs more than 1,400 people worldwide.

IDT expanded its product portfolio through the acquisition of medical genetics company Invitae’s Archer NGS Research Assays in December 2022. IDT also formed a strategic partnership with Aldevron, a plasmid DNA supplier, to distribute CRISPR nucleases produced by the latter.