AGC Biologics Launches BravoAAV™ and ProntoLVV™ Platforms

AGC Biologics announced the launch of its BravoAAV and ProntoLVV viral vector platforms. Leveraging three decades of Lentiviral vector (LVV) and Adeno-Associated Viral vector (AAV) development, manufacturing and analytical experience, AGC Biologics' new platforms offer fast, efficient and reproducible clinical and commercial GMP production and release. The CDMO's proprietary process and capsid-specific platform methods can accelerate development timelines, delivering GMP product in nine months.

TheBravoAAVandProntoLVV platforms have production at different scales in suspension up to 2,000 L and adhesion up to 750 L, and include prequalified scale-down models simplifying and accelerating the path to commercialization.

The AGC Biologics AAV and LVV platforms include in-network plasmid DNA (pDNA) supplies (high-quality and GMP-grade), all major testing performed in-house and the use of cell factories and fixed bed bioreactor for adherent protocols, and wave and stirrer bioreactors for suspension. In addition, BravoAAV and ProntoLVV include a comprehensive set of analytical methods pre-qualified for clinical application and ready to validate for commercial purposes, and a templated material approach to help ease regulatory steps and approvals. The platforms receive support from the AGC Biologics global supply chain network, helping ensure projects start quickly and remain on time.

BravoAAV and ProntoLVV are designed by the scientists at the AGC Biologics Milan site, a group with 30 years of expertise in building custom vector programs that scale to commercial levels and meet global regulatory standards. The global cell and gene team at AGC Biologics has supported four commercial viral vector products, three commercial cell therapies and more than 30 cell and gene therapy clinical trials across Europe and the United States.

AGC Biologics is featuring these new platforms and highlighting their benefits at the American Society of Cell + Gene Therapy's annual conference in Los Angeles, May 16-19, including a featured presentation:

• Friday, May 19, 9:15-9:45 a.m. PST: "Navigating Complexities of Viral Vector Production for Gene Therapies," presented by Dr. Margherita Neri, Vector Process Development Director, AGC Biologics | Exhibition Hall 511 on floor 2.

For more details on BravoAAV, visit www.agcbio.com/capabilities/bravo-adeno-associated-viral-vector-platform-cdmo. You can learn more about ProntoLVV at www.agcbio.com/capabilities/pronto-lentiviral-vectors-production-manufacturing-cdmo-services.

Quotes from AGC Biologics Leadership on BravoAAV and ProntoLVV

"BravoAAV and ProntoLVV are built on custom processes and protocols for viral vector production and manufacturing we created in Milan. During the earliest days of cell and gene treatments, there were no standardized platforms. We had to create processes, systems, analytical panels and custom bioreactor configurations from scratch and adapt them over time," said Giuliana Vallanti, Vice President, Development and R&D Global Cell and Gene, AGC Biologics. "These platforms combine all that expertise and work to bring the industry a new templated approach to complex AAV and LVV development and manufacturing."

"The launch of these two platforms is the latest in a series of enhancement aimed at deliberately growing our cell and gene therapy services to support developers from early phases through clinical and commercial stage manufacturing. By offering a new templated approach for viral vector production, BravoAAV and ProntoLVVwill support companies bringing these life changing treatments by helping to accelerate project timelines, reach clinical and commercial milestones, and deliver effective therapies to patients as quickly as possible," notes Patricio Massera, CEO, AGC Biologics.

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