NewBiologix has announced it has granted a non-exclusive technology license to ReciBioPharm, Recipharm’s Advanced Therapies (ATMP) division and a Contract Development and Manufacturing Organisation (CDMO), to provide global biotech and pharma companies with access to NewBiologix’s Xcell-Eng-HEK293 cell lines.
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HEK293 cells.
The Xcell-Eng-HEK293 cell lines are high-value solutions for manufacturing recombinant adeno-associated viruses (rAAV) for use in C>. NewBiologix provides cGMP-ready, high-yield, viral particle-producing cell lines and manufacturing technologies for developing gene therapies. This unique cell line enables customers to speed up development and quickly advance C> programs to clinical trials. NewBiologix uses advanced technologies combining multidimensional digital PCR with third-generation sequencing. Its tightly controlled cell line coupled with ReciBioPharm’s AAV manufacturing platform leads to excellent scalability and consistent high yields at multiple scales across a wide range of serotypes.
As a result of proprietary innovations and sustained process development efforts using NewBiologix’s cell lines, ReciBioPharm has achieved results across multiple AAV programs. It consistently exceeds 2E15 vg/L, even with large (~5kb) gene-of-interest constructs, demonstrating remarkable process robustness and reproducibility. By combining its proprietary packaging plasmid system with NewBiologix’s advanced HEK293 cell line and downstream purification toolbox, ReciBioPharm delivers >95% full capsids in final product formulations.
In addition, ReciBioPharm has validated high-yield, high-purity AAV production across more than 10 rAAV serotypes, supporting broad therapeutic applicability. Its fully integrated offering, from research-use only (RUO) through to GMP manufacturing, provides a seamless, scalable path to clinic and market for advanced therapy developers.
Igor Fisch, CEO and co-founder of NewBiologix, said: "Our ambition is to become the leading company for providing solutions for gene therapies, based on Swiss engineering and precision. Our technology licensing agreement for ReciBioPharm, a global leader in ATMP development and manufacturing, will help ensure patients benefit from life-saving treatments through economically viable, large-scale production of viral vectors. Core to this offering is our Xcell-Eng-HEK293 cell line, complemented with advanced analytics to guarantee the highest quality AAV for transformative therapeutic solutions. We’re not just advancing gene therapy; we’re redefining how it’s built."
Vikas Gupta, President of ReciBioPharm, said: “Our strategic collaborations and technology advancements in 2024 reaffirmed our commitment to being a trusted partner in ATMPs. Our technology licensing agreement with NewBiologix for the Xcell-Eng-HEK293 cell line strengthens our position in the AAV space. Together, we advance the needs of our customers by driving down the costs of developing and manufacturing high quality AAV therapies.”
Last year, NewBiologix launched its Xcell Portfolio, a suite of advanced technologies that provides deep insights and comprehensive analysis of rAAV quality, which is an ongoing challenge in the field. By integrating its proprietary HEK293-based cell lines with advanced production tools and analytical testing services, the Xcell Portfolio streamlines the journey from research to commercialisation, accelerating the development of safer and more effective gene therapies for patients.