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Enzene Targets Local Biomanufacturing with New Solutions

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CDMO Enzene launched NeX™, which it labels “an end-to-end partnership model that enables governments, institutions, and biopharma organizations to establish world-class biomanufacturing capabilities wherever they need them.”

NeX, built on the EnzeneX® continuous manufacturing (FCCM™) platform, is designed to deliver a turnkey and scalable way to make biologics manufacturing transportable, close to patients and supply chains, while avoiding the capital burden of conventional fed‑batch facilities.

By enabling local FCCM‑based manufacturing, governments can significantly expand patient affordability and access to life‑saving biologics, according to Himanshu Gadgil, PhD, CEO of Enzene.

“A conventional biologics plant often requires between $300 million and $400 million to build,” he says. “With our fully-connected continuous manufacturing platform, the same output can be achieved for $60–$80 million. The efficiency comes from a compact, integrated system architecture rather than the scale-intensive layouts of fed-batch facilities, allowing for long-term cost advantage and high product yields for locally manufactured biomedicines.”

Enzene’s NeX program is intended to help regions accelerate the establishment of local biopharma capabilities and risk-mitigated supply chains, develop domestic scientific talent, and reduce long-term manufacturing costs for local patients, continues Gadgil, adding that the company estimates that facilities built under the program can achieve validation and commercial readiness in under three years.

The post Enzene Targets Local Biomanufacturing with New Solutions appeared first on GEN – Genetic Engineering and Biotechnology News.

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Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad

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The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.

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Gilead looks to upcoming inflammation, cancer catalysts as pressure to diversify mounts

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HIV remained Gilead’s strongest franchise in the second quarter, but the pharma is building out its pipeline beyond virology, particularly focusing on inflammation and oncology.

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STAT+: Moderna launches early trial of Ebola mRNA vaccine

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Good morning. We’ve got a busy earnings week. Here’s the latest.

The need-to-know this morning

Novo vs. Lilly

The two GLP-1 giants have both reported earnings.

Continue to STAT+ to read the full story…

Read More

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