LAUSANNE, Switzerland, Feb. 18, 2026 (GLOBE NEWSWIRE) — NewBiologix S.A., a biotechnology company advancing recombinant adeno-associated virus (rAAV) production through next-generation clonal HEK293 cell line technology, today announced publication of peer-reviewed data in Biotechnology Reports (Vol. 49, March 2026).
The paper (1), authored by NewBiologix, covers the generation and characterization of NBX1P01, the company's proprietary clonal HEK293 cell line optimized for rAAV production. Derived from more than 2,000 single-cell clones, NBX1P01 was selected for enhanced production performance and validated through extensive genomic sequencing to confirm clonality and stability. This clonal cell line underpins rapid, effective, and scalable production of viral vectors central to gene therapy manufacturing.
After comprehensive evaluation, the publication reports the following key findings:
- Full-to-empty capsid ratio: In head-to-head studies using identical protocols, NBX1P01 demonstrated a two-fold higher full-to-empty rAAV capsid ratio compared to a leading commercial HEK293 cell line. Full capsid content is a critical product quality attribute in rAAV manufacturing.
- Genomic stability: The clone remained genomically stable over 55 population doubling levels and exhibited lower genetic heterogeneity than the parental HEK293 population.
- Genome integrity: Long-read sequencing confirmed more than 70% intact rAAV genomes with minimal encapsidated contaminating DNA.
- Scalability and versatility: NBX1P01 demonstrated consistent performance across production volumes ranging from 10 mL to 1.5 L and supported multiple rAAV serotypes and clinically relevant transgene sizes.
Igor Fisch, CEO and Co-founder of NewBiologix, said, “As the gene therapy landscape evolves, manufacturing platforms must radically improve in performance. Our goal is to help revolutionize gene therapy by ushering in a more reliable and consistent industrial scale manufacturing foundation. This peer-reviewed publication validates our precision-built, high performance, stable HEK293 platform and showcases its reliability and consistency for quality rAAV production.”
Efrain Guzman, VP, Innovation & Business Development at NewBiologix, said, “We're determined to make gene therapies more accessible and provide safe and effective therapies to patients. In viral vector manufacturing, quality is essential to assure the product's integrity from day one. Choosing a reliable, stable and adaptable cell line that demonstrates consistent performance is foundational to achieving that goal.”
Manufacturing scalability and product quality remain central challenges in rAAV-based gene therapy development, particularly as programs expand beyond rare diseases into broader patient populations. Improvements in cell line stability impact product quality and dramatically reduce variability, thereby increasing manufacturing efficiency and enhancing overall product consistency.
For additional technical information, see the company's latest Scientific White Paper (2).
References
(1) Generation and characterization of a HEK293 cell line optimized for recombinant adeno-associated virus production: https://doi.org/10.1016/j.btre.2026.e00948
(2) Unlocking Scalable, High-Quality rAAV Production with Xcell(TM) Eng-HEK293: https://145175225.hs-sites-eu1.com/white-paper-hek293
About NewBiologix S.A.
NewBiologix is a next-generation biotechnology company pioneering the future of recombinant adeno-associated virus (rAAV) production through its proprietary, high performance, stable HEK293 platform technology. Headquartered in Lausanne, Switzerland, and backed by a world-class scientific team and leading investors, the company focuses on addressing one of the most critical bottlenecks in gene therapy: reproducible, cost-efficient, and high-quality vector manufacturing. By integrating its proprietary HEK293-based cell lines with its suite of advanced production tools, NewBiologix supports partners from research through commercialization to enable more consistent and reliable gene therapy manufacturing.
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Media contacts
NewBiologix
Igor Fisch, CEO
contact@newbiologix.com
Scius Communications (for NewBiologix)
Katja Stout, katja@sciuscommunications.com
+44 7789 435990
Daniel Gooch, daniel@sciuscommunications.com
+44 7747 875479
