NewBiologix S.A. (Lausanne, Switzerland) has announced the publication of peer-reviewed data in Biotechnology Reports (Vol. 49, March 2026) describing NBX1P01, a clonal HEK293 cell line developed for recombinant adeno-associated virus (rAAV) production.
The paper (1), authored by NewBiologix, reports the generation and characterization of NBX1P01, selected from more than 2,000 single-cell clones and validated through genomic sequencing to confirm clonality and stability. The company positions the cell line as a manufacturing platform intended to support scalable viral vector production for gene therapy.
In the publication, NBX1P01 demonstrated the following performance attributes:
Full-to-empty capsid ratio: In head-to-head studies using identical protocols, NBX1P01 produced a two-fold higher full-to-empty rAAV capsid ratio compared to a leading commercial HEK293 cell line. Full capsid content is a key quality attribute in rAAV manufacturing.
Genomic stability: The clone remained genomically stable over 55 population doubling levels and showed 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 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 establishing a more reliable and consistent industrial-scale manufacturing foundation. This peer-reviewed publication validates our precision-built, high-performance, stable HEK293 platform and demonstrates 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 move beyond rare diseases into broader patient populations. Cell line stability and reduced variability can influence both product consistency and manufacturing efficiency.
For additional technical information, see the company’s latest Scientific White Paper (2).
Generation and characterization of a HEK293 cell line optimized for recombinant adeno-associated virus production: https://doi.org/10.1016/j.btre.2026.e00948
Unlocking Scalable, High-Quality rAAV Production with Xcell™ Eng-HEK293: https://145175225.hs-sites-eu1.com/white-paper-hek293
References:
Generation and characterization of a HEK293 cell line optimized for recombinant adeno-associated virus production: https://doi.org/10.1016/j.btre.2026.e00948
Unlocking Scalable, High-Quality rAAV Production with Xcell™ Eng-HEK293: https://145175225.hs-sites-eu1.com/white-paper-hek293
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