The combined offering helps biopharma developers accelerate clinical programs, reduce scale-up risk, and improve process predictability across development and manufacturing.
E. coli-based recombinant protein production is a cornerstone of the biopharmaceutical industry. Yet the transition from development to clinical-phase manufacturing is often handled across multiple providers, creating delays during process transfer and scale-up. The partnership integrates strain engineering, expression optimization, process development, and manufacturing into a single 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. This partnership exists to change that by making manufacturability part of the conversation from the start. In the current environment, that kind of predictability determines whether a program moves forward at all.” Janet Hoogstraate, CEO, NorthX Biologics
The partnership combines enGenes’ proprietary enGenes-eXpress™ platform, which delivers decision-grade expression data within weeks, with NorthX Biologics’ capabilities in process development, analytics, scale-up, and GMP manufacturing. The result is a continuous workflow from early expression screening to GMP-ready material, with process parameters aligned to GMP requirements from the first expression run.
“The timing of this partnership reflects where the market is heading. 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. enGenes has built a next-generation E. coli platform with key enabling technologies that improve the cost-efficiency and speed of biologics production. NorthX Biologics has the GMP infrastructure and regulatory track record to bring that to patients. Together, we close a gap that neither of us could close alone.” Jürgen Mairhofer, CEO, enGenes Biotech
Under the partnership terms, enGenes performs high-throughput expression optimization, including host/vector screening, soluble expression enhancement, extracellular secretion strategies, and antibiotic marker-free production. The resulting expression system and full technical data package are transferred directly into NorthX Biologics’ pre-validated development and GMP manufacturing workflow. This creates a continuous pathway from genetic construct to clinical-grade material.
As cost pressure and pipeline complexity push biopharma toward microbial expression systems, the partnership addresses a long-standing gap that historically made programs slower and more risk-prone. The pathway enables decision-grade expression data within weeks and earlier Go/No-Go decisions. The companies now offer the pathway to both new and existing customers.
About NorthX Biologics
NorthX Biologics is a leading contract development and manufacturing organization (CDMO) and Sweden’s national innovation hub for advanced biologics, enabling next-generation therapies beyond traditional manufacturing. With over 30 years of GMP experience, NorthX Biologics offers end-to-end services including process development, recombinant proteins, vaccines, viral vectors, cell therapies, and aseptic fill & finish. With its headquarters in Matfors, Sweden, and a facility in Stockholm, NorthX Biologics serves customers worldwide. https://www.nxbio.com/
About enGenes Biotech
enGenes Biotech is a microbial expression technology company specialising in high-performance recombinant protein, peptide, and plasmid DNA production in E. coli. Founded in 2014 and headquartered in Vienna, Austria, the company has built a portfolio of proprietary platforms that consistently deliver titers, solubility, and secretion performance beyond the reach of conventional E. coli systems. Recent peer-reviewed work demonstrated secreted VHH titers of 17 g/L in E. coli, the highest reported in any microbial host. enGenes combines this technology base with end-to-end bioprocess development expertise, from molecular biology and strain engineering through upstream and downstream process design, supporting pharmaceutical, diagnostic, and industrial biotech clients worldwide in reducing production costs and accelerating time to market. https://www.engenes.cc/
Contact
enGenes Biotech GmbH
Muthgasse 11/2, 1. floor
A-1190 Vienna
+43 1 9346707-0
office(at)engenes.cc