Synthego breaks ground on sgRNA manufacturing facility

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Pic:getty/vladmirtimofeev (Getty Images/iStockphoto)

The company plans to use the additional capacity to manufacture synthetic sgRNAs, used in the development of CRISPR-mediated cell and gene therapies.

Synthego, a genome engineering company based in California, announced that it had begun work on a 20,000-square-foot manufacturing facility. The space, which will be located in the San Francisco Bay Area, will expand the company’s Halo platform to increase production of its gene editing tools.

According to the company, Halo is a platform that provides the tools to design, select, and format optimized CRISPR reagents. The platform enables the scale-up or scale-out of CRISPR reagent volumes.

Synthego pitches the platform as a suite of genome editing capabilities that allows partners working on CRISPR-mediated gene therapies to conduct basic research, identify novel targets, and enter clinical trials.

Aside from scaling up the Halo platform, the facility will also provide materials for translational and clinical research development for cell and gene therapies.

The plant is expected to become operational in late 2022, with a ‘significant amount’ of capacity already pre-allocated and prioritized for its existing development partners.

Paul Dabrowski, CEO of Synthego, said, “We designed this facility to deliver our GMP single guide RNA (sgRNA) at scale not only to meet the needs of our biopharma partners, but to drive the industry forward and realize the full potential of the rapidly expanding field of cell and gene therapies.”

The 20,000-square-feet of space will include 10,000-square-feet of lab space, including quality control and R&D labs, and 7,000-square-feet of cleanroom space. The facility will have the capability for 24/7 parallel batch production.

In May 2021, Synthego received ISO 9001:2015 certification based on an audit of the company’s manufacturing process for sgRNA.

Funding to back expansion

In February 2022, Synthego raised $200m (€196m) of capital through various financial partners, including a Series E financing led by Perceptive Advisors.

At the time of the announcement, the company stated that it would use the funding to develop a cell and gene therapy discovery and development ecosystem, with the aim of accelerating translational science into novel therapeutics.

Alongside expanding the capacity of its Halo platform, the company also stated it would do the same for its second platform, Eclipse. The latter platform provides a cell engineering process to industrialize CRISPR editing to deliver cell-based models for disease research.

Its Series E financing doubled the capital raised in its previous round, when it drew in $100m during Series D financing.

There was further good news in July for Synthego, though not in the best circumstances. A California federal judge granted a stay request in Synthego’s favour, after Agilent attempted to block sales of its genome-editing products due to a lawsuit over claims that Synthego had violated two of its patents. The financial backing, secured after the lawsuit was launched, could be seen as a vote of confidence in the Synthego business.