HAMBURG, Germany, Sept. 9, 2021 /PRNewswire/ — GeneQuine Biotherapeutics GmbH, a biotech company focused on the development of gene therapy for musculoskeletal disorders, today 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.”
About Genequine Biotherapeutics GmbH
GeneQuine Biotherapeutics GmbH is a biotech company focused on the development of innovative gene therapies for treatment of musculoskeletal disorders. GeneQuine’s aim is to use its gene therapy platform to established sustained production of therapeutic proteins locally in the tissues or organs where they are needed. The lead candidate GQ-303 is being developed as a locally administered treatment for osteoarthritis and has demonstrated the potential to be a symptomatic and disease-modifying treatment in several animal models. In 2017, Flexion Therapeutics, Inc. acquired GeneQuine’s then-lead program for osteoarthritis, which is based on the same gene therapy vector technology as GQ-303 and is currently in clinical Phase 1 testing. GeneQuine is headquartered in Hamburg, Germany and has sites at Luckenwalde (greater Berlin area), Germany and Liège, Belgium.
About Exothera SA
Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing.
.LinkedIn: https://www.linkedin.com/company/exothera / Website: www.exothera.world
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