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NorthX Biologics and enGenes Launch Integrated E. coli Manufacturing Pathway

COMPANY PROFILE
  • NorthX Biologics and enGenes Biotech have partnered to create an integrated development and manufacturing pathway for recombinant protein programs using E. coli expression systems.
  • The companies said the workflow could reduce early-stage development timelines by three to six months by integrating expression optimization with GMP manufacturing.

NorthX Biologics and enGenes Biotech have entered a partnership to provide an integrated development and manufacturing pathway for recombinant protein programs produced in E. coli, aiming to reduce delays between expression system development and GMP manufacturing.

The companies stated that recombinant protein development programs frequently face delays when transitioning between separate development and manufacturing providers. Under the collaboration, strain engineering, expression optimisation, process development, analytics, scale-up, and GMP manufacturing will be integrated into a single workflow intended to improve process predictability and reduce scale-up risks.

According to the companies, the pathway combines enGenes’ enGenes-eXpress™ platform with NorthX Biologics’ process development and GMP manufacturing infrastructure. The integrated approach is designed to deliver decision-grade expression data within weeks and support earlier Go/No-Go decisions for biopharmaceutical developers.

“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

Under the partnership, enGenes will conduct host and vector screening, soluble expression optimisation, secretion strategy development, and antibiotic marker-free production before transferring the expression system and technical data package into NorthX Biologics’ GMP manufacturing workflow. The companies said the pathway is now available to both new and existing customers, expanding their combined CDMO and contract manufacturing capabilities for microbial biologics production.

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