Bacterial Expression Tech Prompts NorthX and enGenes Collaboration

Bacterial expression systems are becoming more versatile, say Swedish contractor NorthX Biologics and Austrian technology firm enGenes Biotech, who have teamed up to create an integrated, E.coli-based protein production platform.

E.coli-based protein expression systems are not a new idea. They have been around since the 1970s and used to make everything from recombinant human insulin to treatments for growth hormone deficiency.

They are generally cheaper than expression systems that use mammalian cells, primarily due to lower reagent costs. They also tend to be faster to set up, easier to scale, and have a reduced risk of viral contamination.

Typically, E.coli-based systems are selected for the manufacture of simple proteins that do not require human-like post-translational modifications such as glycosylation. However, recent advances in strain engineering are starting to expand their scope.

As a result, more biopharmaceutical firms are considering them for commercial-scale protein production, says Ola Tuvesson, CTO at NorthX, who cites this demand as a driver for the enGenes partnership.

“The biggest growth vectors are biosimilar manufacturing, peptide therapeutics, and antibody fragments, including ADC components. Advances in glycosylation engineering are also expanding what the platform can address at the higher end of biologics complexity.

“Several trends are reinforcing this direction: sustained pricing pressure pushing biopharma away from higher-cost production systems for this segment of the pipeline, growing investment in CRISPR-based strain engineering that extends microbial platforms into more complex program types, and a manufacturing infrastructure that needs to keep pace with industry demand,” Tuvesson tells GEN.

Integrated pathway

NorthX Biologics and enGenes’ strategy is to offer an integrated service that covers everything from strain design through manufacture.

Tuvesson says, “The E. coli development to GMP manufacturing pathway typically covers expression system development, process development, scale-up, and transfer into GMP production. While the technical steps are well established, the challenge in many programs is that these stages are often handled by different providers, leading to delays, rework, and increased scale-up risk.

“The pathway we are establishing addresses this fragmentation by integrating expression development and GMP manufacturing into a single, aligned workflow. This reduces handovers, improves data continuity, and helps ensure that the expression system is optimized from the start for manufacturing at scale,” he adds.

The new pathway will combine high-throughput screening platforms, multi‑fermenter systems, and multivariate experimental design with advanced analytical support and scale-up engineering.

According to NorthX Biologics and enGenes Biotech, the idea is to enable rapid iteration and the generation of decision-grade data early in development, supporting more robust and scalable processes.

There is an option to extend the partnership, according to Tuvesson, who says, “The collaboration may also open up opportunities to implement more continuous manufacturing approaches over time.”

The firms plan to monetize the platform by providing it to biopharma customers as a manufacturing service, rather than out-licensing, as Tuvesson explains.

“Expression systems and processes developed for a specific protein can be transferred under standard commercial terms. However, the pathway itself is not a standalone licensable product.

“The focus is instead on integrating expression development and manufacturing into a single workflow, reducing handovers and enabling faster development timelines,” he says.

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