NewBiologix, a next-generation biotechnology company pioneering the future of recombinant adeno-associated virus (rAAV) production through a unique DNA-based platform built on stable cell line technology, has published a new scientific white paper detailing the adaptability, flexibility and scalability of its Eng-HEK293 clonal cell line for rAAV production.

rAAVs remain among the most widely used vectors for producing gene therapies, supported by growing clinical successes.The HEK293 continues to serve as the preferred platform for their production.

Developed in collaboration with NewBiologix’s partner RecibioPharm, the white paper provides comprehensive details on the company’s fully characterized, serum-free, suspension-adapted, clonal HEK293 cell line. This line has been specifically developed for high-quality clinical and commercial production of rAAV. 

The paper demonstrates the cell line’s flexibility to grow and produce rAAV across a range of GMP-ready, off-the-shelf media formulations. It also highlights the robustness of rAAV production across different culture volumes and bioreactor systems. In addition, it showcases the cell line’s performance in large-scale rAAV production using a clinically relevant transgene.

“The manufacturing stage in gene therapies poses the biggest bottleneck,” said Efrain Guzman, VP, Innovation & Business Development at NewBiologix. “To achieve success in producing gene therapy vectors at scale for commercial applications, choice of cell line is crucial. It’s essential to have a flexible and adaptable cell line that shows excellent, and consistent, performance in leading bioreactor systems – as demonstrated by our Eng-HEK293 clonal cell line.” 

“Our ambition is to become the leading company for providing solutions for gene therapies, based on Swiss engineering and precision,” added Igor Fisch, CEO and co-founder of NewBiologix. “Reliable cells are the foundation of scalable platforms to produce high-quality rAAV and ensure the widest possible benefit from gene therapies. Our latest white paper, produced by our talented team in collaboration with our partner RecibioPharm at its commercial viral vector production facility, underlines how we’re not just advancing gene therapy, we’re redefining how it’s built."

The white paper complements NewBiologix’s Xcell™ Portfolio, a suite of advanced technologies designed to provide deep insights and comprehensive analysis of rAAV quality – an ongoing challenge in the field. By integrating proprietary HEK293-based cell lines with advanced production tools and analytical testing services, the Xcell Portfolio streamlines the journey from research to commercialization, accelerating the development of safer and more effective gene therapies for patients.

‍Read the full white paper: Adaptability, flexibility and scalability of NewBiologix’s Eng-HEK293 clonal cell line for recombinant adeno-associated virus vector production