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nAAVigation® Vector Platform Accelerates Gene Therapy Programs
AAV platform process has the capability to cut a viral vector gene therapy program timeline to GMP by more than half versus traditional process development.
Leveraging decades of Adeno-Associated Virus (AAV) vector contract development and manufacturing (CDMO) experience, we have established an industry-leading platform which streamlines the pathway to GMP AAV vector manufacturing.
Without the need for substantial process development, nAAVigation® provides viral vector gene therapy developers with the capability to reduce a program’s timeline to GMP for viral vector gene therapy developers by 55%, translating to fewer than eight months compared to traditional manufacturing workflows.
The approach is based on a proprietary high-productivity HEK293 suspension cell line which is amenable to clients’ scale-up and serotype needs and utilizes an optimized single-use upstream approach coupled with robust downstream purification processes. This combination enables client AAV programs to scale up to 500 L in suspension and accelerates time to clinic through secure development processes, available materials, templated documents, and 100% qualified, in-house analytical capabilities.
“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.” Commented Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, in a press release announcing the platform. “By increasing speed and efficiency for viral vector production, nAAVigation® will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.”
Launch at Meeting on the Mesa
The nAAVigation® platform was debuted during a Charles River-hosted reception on October 12, during Cell and Gene Meeting on the Mesa, in Carlsbad, CA. Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services showcased supporting data and highlighted the key benefits of the platform to viral vector gene therapy developers:
- Speed: Expedited development and 100% in-house analytics
- Experience: Differentiated CDMO and fully integrated testing powerhouse
- Predictability: Cost-effective, reliable path to GMP and clinic
Prof. Daniel Smith, PhD, Executive Director Global Cell and Gene Therapy Portfolio, who also presented during the three-day conference, commented: “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.”
nAAVigation® Launch: Meeting on the Mesa
Join Ramin Baghirzade to explore our AAV production platform and discover key benefits to gene therapy developers including reduced time to clinic, experience, and predictability.
Watch Now On-Demand
For more information on our viral vector development and manufacturing services, including scaled GMP production of AAV, lentiviral vector, adenovirus, and retrovirus, viral vector packaging services, and products, please visit: Cell and Gene Therapy CDMO Solutions.