Entos Pharmaceuticals Launches GMP Clinical Manufacturing Facility in Carlsbad, California

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来源: Business Wire

'The addition of Swapnil to our senior leadership team will ensure Entos\' new facility will meet or exceed requirements for global operations'

Preview

来源: Business Wire

EDMONTON, Alberta & SAN DIEGO--(BUSINESS WIRE)--Entos Pharmaceuticals (Entos), a clinical-stage biotechnology company developing genetic medicines with its proprietary Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced the launch of its new Good Manufacturing Practices (GMP) manufacturing facility in Carlsbad, California. This new site will allow Entos to 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 state-of-the-art facility features 20,000 square feet 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.

Concurrently, Entos announces the appointment of Swapnil Ballal as the company’s Vice President of Manufacturing. With almost 30 years of experience in biopharmaceutical manufacturing and quality assurance, Mr. Ballal brings a wealth of expertise to his new role, 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.”

"The addition of Swapnil to our senior leadership team will ensure Entos' new facility will meet or exceed requirements for global operations,” said John Lewis, Ph.D., founder and CEO of Entos. “Our Carlsbad site represents a strategic opportunity for us to expedite the development of GMP-grade Fusogenix PLV required for clinical trials. GMP production is a crucial milestone in our mission to develop and manufacture safe and effective genetic medicines to address global health challenges."

The launch of this new Entos facility is a key step in the company’s global manufacturing strategy as it looks to establish a future manufacturing site in Edmonton, Alberta, Canada, to enable the commercial manufacturing of emerging transformative medicines for Entos and its valued partners.

About Entos Pharmaceuticals

A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and re-dosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of nucleic acid into target cells through direct fusion. For more information, visit www.entospharma.com, or follow Entos on LinkedIn.

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