LAUSANNE, Switzerland, September 2, 2026
NewBiologix S.A. has entered into an agreement with Synastra Biotechnology Inc. to develop a stable producer cell line for Synastra’s investigational Duchenne muscular dystrophy (DMD) gene therapy program. Under the collaboration, NewBiologix will apply its proprietary Xcell™ Stable Manufacturing Platform to generate and characterize a stable Research Cell Bank for Synastra’s AAV-based micro-dystrophin candidate. The agreement also includes an option to transition the program to a commercial license, potentially supporting future clinical and commercial manufacturing as development advances.
Xcell™ Platform Targets rAAV Manufacturing Challenges
The collaboration combines Synastra’s capabilities in genomic engineering, AAV vector design, rare-disease gene therapy and translational development with NewBiologix’s cell engineering and recombinant AAV manufacturing technologies. NewBiologix will focus on establishing a genetically defined, reproducible and scalable production system designed to support Synastra’s program through clinical translation and potentially commercial supply. The Xcell™ platform is designed to replace repeated transient transfection with genetically engineered stable producer cell lines, with the objective of reducing manufacturing complexity and variability while improving scalability. The approach is particularly relevant for gene therapies requiring high quantities of rAAV vector.
DMD Creates High-Demand Vector Manufacturing Requirements
Duchenne muscular dystrophy is a severe, progressive X-linked neuromuscular disorder caused by mutations in the DMD gene, resulting in insufficient functional dystrophin and progressive muscle degeneration. Gene therapy manufacturing can present significant challenges in DMD because systemic administration may require very high vector doses, increasing the importance of rAAV productivity, consistency, scalability and manufacturing economics. By addressing manufacturing requirements earlier in development, NewBiologix and Synastra aim to establish a production foundation that can support the investigational therapy as it progresses toward clinical development. Synastra’s lead program is an AAV-based micro-dystrophin candidate, developed within an ecosystem involving Üsküdar University, including TRGENMER, and Unifon-Biotech GSYF Venture Capital Investment Fund.
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Partnership Supports Türkiye-Originated Gene Therapy
The agreement represents a strategic step toward connecting gene therapy development with scalable manufacturing infrastructure for Synastra’s DMD program. Synastra said its objective is to translate Türkiye’s capabilities in genomic engineering and biotechnology into internationally competitive therapies for rare genetic diseases while aligning development with international quality and regulatory expectations. For NewBiologix, the collaboration provides an opportunity to apply its stable rAAV manufacturing approach to a high-dose gene therapy application where production capacity and consistency can be critical development considerations. The companies will initially establish and characterize the stable Research Cell Bank, while the commercial licensing option could provide a pathway toward longer-term manufacturing support if the program progresses successfully.
Source:NewBiologix, press relese
