NorthX Biologics, enGenes Biotech partner on integrated E. coli protein manufacturing

NorthX Biologics, a contract development and manufacturing organization (CDMO), and enGenes Biotech, an E. coli expression technology company based in Vienna, Austria, have announced a partnership to offer an integrated development and manufacturing pathway for recombinant protein programs produced in E. coli.

The partnership combines enGenes’ expression data platform, with NorthX Biologics’ process development, analytics, scale-up, and GMP manufacturing capabilities. The integrated workflow spans strain engineering, expression optimization, process development, and GMP manufacturing within a single pathway, with process parameters aligned to GMP requirements from the first expression run, according to the announcement.

The collaboration is designed to address the delays that commonly occur when expression system development and GMP manufacturing are handled across multiple providers, which the companies said can cost early-stage programs three to six months in development time during process transfer and scale-up.

Under the partnership, enGenes performs high-throughput expression optimization — including host and vector screening, soluble expression enhancement, and antibiotic marker-free production — before transferring the resulting expression system and technical data package directly into NorthX Biologics’ pre-validated GMP manufacturing workflow.

“The biotech companies we work with are under real pressure. Less capital, faster timelines, higher expectations from investors. Still, programs arrive at GMP with expression systems that were never built to scale, and fixing that can take months,” Janet Hoogstraate, CEO of NorthX Biologics, said in a statement. “This partnership exists to change that by making manufacturability part of the conversation from the start.”

“Biosimilar pipelines are expanding, cost pressures are intensifying, and customers are looking for manufacturing solutions that are both technically differentiated and GMP-credible from day one,” added Jürgen Mairhofer, CEO of enGenes Biotech. “Together, we close a gap that neither of us could close alone.”