The Companies Senior Director and Global Head of Commercial Gene Therapy CDMO Services, Ramin Baghirzade will outline how this platform will accelerate its gene therapy manufacturing programs in the session ‘nAAVigationTM Vector Platform: Accelerating Your AAV Pathway to GMP and Clinic’ on Wednesday 12th Oct.
Built from years of AAV vector CDMO experience, expertise, and testing, the nAAVigation platform will streamline GMP AAV vector manufacturing. This will allow GMP viral vectorgene therapy developers to reduce their timelines by up to 55%, compared to traditional manufacturing workflows.
nAAVigation accelerates the time to clinic to less than eight months by leveraging established developmental processes, template documents, on-hand materials, and 100% qualified, in-house analytics.
“The significant turnaround time reduction for viral vector therapy developers utilizing nAAVigation combined with Charles River’s established development process, standard, on-hand materials, templated documents, and in-house analytics will enhance our clients’ experiences,” said Professor Daniel Smith, Executive Director Global Cell and Gene Therapy Portfolio, Charles River.
The nAAVigation platform is based upon the proprietary high-productivity HEK293 suspension cell line and couples an optimized single-use upstream system with a robust downs-stream purification process, enabling clients the capacity to scale-up to 500L in suspension.
This launch enhances Charles River’s extensive cell and gene therapy end-to-end support and supply chain simplification offerings to its expanding ATMP portfolio.
“The launch of the nAAVigation Vector Platform process is the latest in a series of portfolio enhancements aimed at supporting our cell and gene therapy clients from early target identification through clinical-stage manufacturing. By increasing speed and efficiency for viral vector production, nAAVigation will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster,” commented Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River.
Xavier De Mollerat Du Jeu, Senior Director R&D at Thermo Fisher Scientific is accompanied by Gianluca Pettiti, Executive Vice President and President, Life Sciences Group at Thermo Fisher Scientific and Fred Parietti, Co-Founder and CEO at Multiply Labs for this Workshop at Advanced Therapies Week 2024.
Manufacturing capacity, complexity and cost are core constraints that limit commercialization of cell and gene therapies, and ultimately patient access. In this Fireside Chat series, join Georgi Makin, VP of Digital & Editorial at Phacilitate and the Germfree team as we discuss the challenges and opportunities associated with delivering cell therapies in a decentralized manufacturing model.