Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, launched its new GMP manufacturing facility in Carlsbad, CA. The new site will support in-house production of drug substance for IND-enabling studies and clinical trials of the company’s pipeline of proprietary and partnered programs.
 

The facility features 20,000 sq.-ft. of dedicated manufacturing space, including a lipid formulation production suite with additional suites dedicated to mRNA and plasmid DNA manufacturing. This facility is intended to support the clinical development of genetic medicine programs, including Covigenix, a COVID-19 booster vaccine, as well as future candidates in rare disease, eye and ophthalmic conditions, oncology, and other infectious diseases. The site would also support the manufacturing of clinical candidates for partnered programs for central nervous system disorders.
 

Additionally, Entos has appointed Swapnil Ballal as the company’s Vice President of Manufacturing. Mr. Ballal brings almost 30 years of experience in biopharmaceutical manufacturing and quality assurance, including a distinguished career in Manufacturing and Quality leadership positions and a proven track record of supporting more than 10 globally marketed biologic drugs.
 

“This marks an exciting era for Entos,” said Swapnil Ballal, Vice President of Manufacturing at 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.”

 

Entos aims to establish a future manufacturing site in Edmonton, Alberta, Canada, to enable the commercial manufacturing of emerging medicines for Entos and its partners.