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.
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