GeneQuine Biotherapeutics GmbH, a biotech company focused on the development of gene therapy for musculoskeletal disorders, announced that it has contracted Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO), to conduct a feasibility study for the development of a large-scale manufacturing process for its osteoarthritis gene therapy product candidate GQ-303 in the highly scalable scale-X™ fixed-bed bioreactor.
GeneQuine is developing GQ-303, its intraarticular gene therapy candidate, which turns joint cells into factories for production of the therapeutic protein proteoglycan 4. Proteoglycan 4 improves lubrication and inhibits molecular pathways that promote disease progression in osteoarthritis. Besides GQ-303, GeneQuine also develops other gene therapies based on the same vector technology, called helper-dependent adenoviral vectors. Since GeneQuine’s product candidates are being developed for large indications such as osteoarthritis, the company is seeking to establish a large-scale manufacturing process for helper-dependent adenoviral vectors.
Exothera is a leading CDMO specialized in the industrialization of vaccine and gene therapy processes (for both adherent and suspension cell systems). Exothera’s technology capabilities includes the scale-X platform that covers applications from rapid proof-of-concepts to early-stage process development and large-scale GMP commercial manufacturing. Exothera will collaborate with GeneQuine to perform a feasibility study with the small-scale version of the scale-X bioreactor to assess the suitability of the platform for production of GQ-303 and GeneQuine’s other product candidates.
“New approaches in bioprocessing will be required to overcome the complexities of gene therapy manufacturing. The right process design and development is a critical early step to create a sustainable gene therapy, said Romain de Rauville, VP Business Development at Exothera. “We aim to provide our partners with a commercial competitive advantage and help make their innovative treatment affordable for more patients.”
“GeneQuine’s aim is to develop gene therapies for large indications. Therefore, it is crucial for us to develop a truly scalable manufacturing process to be able to serve large patient populations with GQ-303 and our other product candidates”, commented Gauthier Poncelet, Manufacturing Manager at GeneQuine. “We are excited to work with Exothera and leverage their expertise to evaluate the suitability of the scale X bioreactor in our production process.”