GeneQuine Biotherapeutics, a German biotech company focused on the development of gene therapy for musculoskeletal disorders, contracted Belgium-based Exothera, a CDMO, to conduct a feasibility study for the development of a large-scale manufacturing process or its osteoarthritis gene therapy product candidate GQ-303 in the 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, which 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 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 specializes 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 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,” says Romain de Rauville, vice president, business development, 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,” adds 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.”