NewBiologix, based in Switzerland, has entered into a strategic agreement with Turkey’s Synastra Biotechnology to develop a stable producer cell line for the latter’s investigational gene therapy targeting Duchenne muscular dystrophy (DMD). This partnership leverages Synastra’s expertise in genomic engineering and rare-disease gene therapy, alongside NewBiologix’s advanced rAAV manufacturing technologies.
Under this collaboration, NewBiologix will utilize its proprietary Xcell™ stable manufacturing platform to create and characterize a research cell bank for Synastra’s DMD candidate. The agreement also includes an option for commercial licensing, facilitating a seamless transition to clinical and commercial manufacturing. By addressing manufacturing challenges early in the development process, the companies aim to establish a robust, scalable production system that supports the progression of the therapy towards clinical application.
DMD, a severe neuromuscular disorder affecting approximately one in 5,000 male births, necessitates high vector doses for effective systemic treatment. This critical need underscores the importance of rAAV productivity, consistency, and scalability in the development of gene therapies. Igor Fisch, PhD, CEO of NewBiologix, emphasizes that conventional transient transfection methods are complex and costly, which can hinder the scalability of gene therapies. The integration of stable producer cell lines into the manufacturing process is envisioned to simplify and enhance the reproducibility of rAAV production, making therapies more accessible to patients.
Cihan Tastan, PhD, deputy chairman of Synastra, highlights the company’s commitment to translating Turkey’s genomic engineering capabilities into competitive gene therapies for rare diseases. The collaboration aims to align construct design with scalable rAAV manufacturing, ensuring a comprehensive approach to DMD therapy development.
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