Cell therapy weekly: US$1 billion investment into cell therapy manufacturing facility
This week: NewBiologix S.A.’s (Epalinges, Switzerland) peer-reviewed report demonstrated its proprietary cell line’s potential to optimize recombinant adeno-associated virus production and a former partnership expands to further support a CRISPR-edited GD2 CAR-T therapy. Plus, Johnson & Johnson (NJ, USA) announced its more than US$1 billion investment in a new US facility for cell therapy manufacturing.
The news highlights:
- Stable clonal cell line for optimized rAAV production
- Expanded partnership to manufacture CRISPR CAR-T for solid tumors
- US$1 billion investment into cell therapy manufacturing facility
Stable clonal cell line for optimized rAAV production
Swiss Biotechnology company NewBiologix S.A. has detailed the generation and characterization of its proprietary clonal HEK293 cell line, NBX1P01, in a peer-reviewed publication, validating its “precision-built, high performance, stable HEK293 platform and [showcasing] its reliability and consistency for quality rAAV production,” notes the company’s CEO and co-founder, Igor Fisch.
According to the paper, NBX1P01 supports rapid, effective and scalable production of viral vectors – an important factor in gene therapy manufacturing. NBX1P01 demonstrated:
- A two-fold higher full-to-empty capsid ratio compared to a leading commercial HEK293 cell line.
- Genome stability over 55 population doubling levels
- Genome integrity with more than 70% intact rAAV genomes with minimal encapsidated contaminating DNA
- Consistent performance across production volumes
“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,” said Efrain Guzman, Vice President of Innovation & Business Development at NewBiologix.
Expanded partnership to manufacture CRISPR CAR-T for solid tumors
Cellares (CA, USA) will be supporting the clinical production and regulatory advancement of the University of Wisconsin School of Medicine and Public Health’s (WI, USA) CRISPR-edited GD2 CAR-T investigational therapy for solid tumors, expanding upon their partnership formed in April 2025.
The GD2 CAR-T program uses CRISPR gene editing to modify patient T cells via electroporation. Initially focused on high-grade gliomas, the therapy could inform future studies into GD2+ cancers such as neuroblastoma, osteosarcoma and melanoma, which have limited therapeutic options for refractory or relapsed cases.
While Cellares will provide manufacturing and regulatory support, the university will retain full ownership and leadership of the Investigational New Drug application filing process.
“Academic medical centers originate many of the cell therapies that eventually reach patients, but the path from proof-of-concept to IND-ready production has historically added years to the development timeline,” said Fabian Gerlinghaus, co-founder and CEO of Cellares. “We believe that automated production can shorten that path and, through this clinical manufacturing collaboration with UW, we are committed to applying the Cell Shuttle and Cell Q platforms to support the full development lifecycle.”
US$1 billion investment into cell therapy manufacturing facility
Johnson & Johnson is set to expand its US manufacturing capacity with a brand new US$1 billion investment into a new facility in Montgomery County, Pennsylvania. Further strengthening the company’s portfolio, the new facility will cater to next generation cell therapy manufacturing for various indications including cancer, immune-mediated and neurological diseases.
“For 140 years, Johnson & Johnson has been a leading innovator in American healthcare, and we are honored to continue advancing that legacy in Pennsylvania,” said Joaquin Duato, Chairman and CEO of Johnson & Johnson.
In March 2025, the company unveiled its plans to invest more than US$55 billion in a four-year margin across manufacturing, research and development, and technology through to 2029.
“By uniting scientific excellence with state-of-the-art manufacturing and strategic investment, and by working collaboratively with our communities, we are delivering for patients and creating significant opportunities for workers and families,” continued Duato.
