The facility is designed to bolster in-house production of drug substances for Investigational New Drug (IND)-enabling studies and trials. This development is pivotal for the company’s proprietary and partnered programme pipelines.
The 20,000ft2 facility includes a lipid formulation production suite and additional suites for mRNA and plasmid DNA (pDNA) manufacturing.
The site is strategically equipped to advance the clinical development of genetic medicine programmes. Among these is Covigenix, a Covid-19 booster vaccine, and future candidates targeting rare disease, eye and ophthalmic conditions, oncology, and other infectious diseases.
Entos’ new facility will manufacture the therapies based on its Fusogenix PLV platform.
Furthermore, the Carlsbad facility will play a crucial role in producing clinical candidates for partnered programmes, particularly those aimed at treating central nervous system disorders.
The establishment of this facility marks a significant milestone in Entos’ global manufacturing strategy.
Entos is also planning to set up a manufacturing site in Edmonton, Alberta, Canada to facilitate the commercial production of transformative medicines for the company as well as its partners.
In line with these advancements, Entos has announced the appointment of Swapnil Ballal as Manufacturing vice-president.
Ballal said: “This marks an exciting era for Entos. The successful commissioning of the site, followed by GMP batch manufacturing, exemplifies the potential of our facility.
“With mRNA and pDNA capabilities, Entos is poised to internally manufacture a substantial portion of our drug product, aligning with the rapid pace of development of our exciting product pipeline.”