NewBiologix, a technology innovation company specializing in viral vector production for cell and gene therapy (C>), has granted a non-exclusive technology license to ReciBioPharm, Recipharm's Advanced Therapies division. The agreement provides global biotech and pharmaceutical companies access to NewBiologix's high-yield Xcell-Eng-HEK293 cell lines for manufacturing recombinant adeno-associated viruses (rAAV).
The partnership aims to address critical challenges in gene therapy manufacturing by combining NewBiologix's engineered cell lines with ReciBioPharm's manufacturing expertise to accelerate development timelines and reduce production costs.
Industry-Leading Performance Metrics
Process development efforts utilizing NewBiologix's cell lines have yielded exceptional results across multiple AAV programs at ReciBioPharm. The platform consistently achieves viral titers exceeding 2E15 vector genomes per liter (vg/L), even when working with challenging large gene constructs of approximately 5kb. This represents significant improvement over industry standards and demonstrates remarkable process robustness.
By integrating NewBiologix's advanced HEK293 cell line with ReciBioPharm's proprietary packaging plasmid system and downstream purification toolbox, the partnership delivers final product formulations with greater than 95% full capsids—a critical quality attribute for therapeutic efficacy.
"Our ambition is to become the leading company for providing solutions for gene therapies, based on Swiss engineering and precision," said Igor Fisch, CEO and co-founder of NewBiologix. "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."
Broad Serotype Compatibility
A key advantage of the licensed technology is its versatility across viral serotypes. ReciBioPharm has validated high-yield, high-purity AAV production across more than 10 rAAV serotypes, supporting broad therapeutic applicability for various disease targets and tissue specificities.
This flexibility allows developers to select optimal serotypes for their specific therapeutic applications without compromising on manufacturing efficiency or product quality.
Integrated Development Pathway
ReciBioPharm offers a fully integrated service from research-use only (RUO) material through to GMP manufacturing, providing a seamless, scalable path to clinic and market for advanced therapy developers.
"Our technology licensing agreement with NewBiologix for the Xcell-Eng-HEK293 cell line strengthens our position in the AAV space," commented Vikas Gupta, President of ReciBioPharm. "Together, we advance the needs of our customers by driving down the costs of developing and manufacturing high quality AAV therapies."
Advanced Analytical Capabilities
The partnership leverages NewBiologix's advanced technologies combining multidimensional digital PCR with third-generation sequencing. Last year, NewBiologix launched its Xcell™ Portfolio, a suite of technologies that provides comprehensive analysis of rAAV quality—an ongoing challenge in the field.
These analytical capabilities help ensure consistent product quality and address regulatory requirements for advanced therapy medicinal products (ATMPs). The company recently published a white paper titled "Recombinant AAV characterization using advanced digital PCR and third-generation sequencing technologies to assess AAV quality and safety," highlighting their approach to viral vector characterization.
Market Impact and Future Outlook
The collaboration comes at a critical time for the gene therapy sector, which faces significant manufacturing challenges including high production costs, scalability issues, and quality control concerns. By addressing these limitations, the NewBiologix-ReciBioPharm partnership aims to accelerate the development of safer and more effective gene therapies.
ReciBioPharm, with its network of clinical and commercial-ready sites across the EU and US, is positioned to implement this technology at scale. The company employs over 5,000 people worldwide and offers comprehensive pharmaceutical development and manufacturing services.
For gene therapy developers, this technology licensing agreement represents an opportunity to access advanced manufacturing capabilities that could potentially reduce development timelines and costs while maintaining high product quality standards—ultimately benefiting patients awaiting these transformative therapies.
