Dive Brief:
- Biotech company Entos Pharmaceuticals opened a genetic medicine manufacturing site in Carlsbad, California.
- The 20,000-square-foot facility will support substance production for investigational new drug application-enabling studies and clinical trials. The site will also be a space for messenger RNA and plasmid DNA manufacturing.
- Canada-based Entos has invested over $2 million in the Carlsbad facility so far and intends to align manufacturing capacity with the pace of development of its in-house and partnered product pipeline.
Dive Insight:
The new facility will also support the clinical development of genetic medicine programs, including Covigenix, a COVID-19 booster vaccine, as well as future candidates in rare disease, eye (or ophthalmic) conditions, cancer other infectious diseases.
The site is currently in commission and has space for 25 to 30 technical employees and up to 50 staff members, a company spokesperson told Manufacturing Dive in an email.
The Carlsbad site is an opportunity for Entos to expedite the development of required good manufacturing practices for its Fusogenix proteolipid vehicle for clinical trials, John Lewis, founder and CEO of Entos, said in the press release.
“GMP production is a crucial milestone in our mission to develop and manufacture safe and effective genetic medicines to address global health challenges,” Lewis said in a statement.
In January 2022, Entos partnered with Eli Lilly because of its distinct Fusogenix nucleic acid delivery technology. In an exclusive agreement, the two companies now develop and commercialize nucleic acid products together.
Down the line, the biotech company said it plans to establish a future commercial-scale manufacturing site in Edmonton, Alberta, according to the press release.
Entos recently appointed Swapnil Ballal as vice president of manufacturing to oversee the facility and the company’s broader manufacturing strategy.
