VirusExpress® 293 Production Platform by Merck: High-Yield, Scalable AAV & Lentivirus Manufacturing for Advanced Gene Therapy

Efficient viral vector manufacturing is critical for today’s gene therapy development. Scalability, speed, and robust yields are key industry demands that are often difficult to achieve. VirusExpress® 293 Production Platform offers a transfection-based, GMP-compliant solution for scalable AAV and lentivirus production, streamlining upstream processes and accelerating therapy delivery. Discover how this advanced system supports both research and commercial applications with proven performance and regulatory compliance.

Why Choose the VirusExpress 293 Production Platform for AAV and Lentivirus Manufacturing

• Addresses viral vector production challenges: Helps overcome common AAV and lentiviral production challenges with a transfection-based manufacturing solution.
• Supports scalable manufacturing: Enables suspension-based upstream production that is optimized for process scale-up.
• Reduces development timelines: Saves time in process development and scale-up to help move programs forward more efficiently.
• Accelerates therapy delivery: Supports faster progress toward getting gene therapies to patients.
• Improves regulatory readiness: Provides full traceability and documentation that can support regulatory filings.
• Expands program flexibility: Offers licensing options for research as well as clinical and commercial use.
• Strengthens manufacturing confidence: Provides a fully characterized and tested platform aligned with clinical and commercial development needs.

What’s Included in the VirusExpress 293 Production Platform

• Transfection-based platform: Platform architecture built around a transfection-based solution for AAV and lentiviral production.
• Cell line component: Suspension-adapted HEK293 cells are used for AAV production and suspension-adapted HEK293T cells are used for lentiviral production.
• Production cell architecture: VirusExpress® 293 AAV Production cells are single-cell cloned and suspension adapted into chemically defined cell culture medium.
• Medium component: EX-CELL® CD HEK293 Viral Vector Medium (14385C) is the chemically defined cell culture medium used within the AAV production platform.
• Upstream process architecture: The platform incorporates an optimized upstream process for scalable, suspension-based viral vector production.
• Transient transfection medium support: The medium is formulated to support transient transfection conditions for viral vector manufacturing workflows.
• Bioreactor development element: Bioreactor process development and scale-up are part of the platform configuration.
• Clinically relevant process element: Includes a process designed to be representative of clinical viral vector production.
• Cell banking status: The cell bank was manufactured and characterized under GMP regulations 21 CFR 210, 211, 600, and 610.
• Characterization package: The production cells are GMP-banked, fully characterized, and adventitious agent tested.
• Regulatory documentation: Full traceability is supported with documentation available for regulatory filings.
• Transfection compatibility: EX-CELL® CD HEK293 Viral Vector Medium supports polyethyleneimine (PEI), lipid polymer-based, and cationic polymer-based transfection protocols where stated.
• Feedstream configuration: The cell culture medium is presented as a simplified feedstream solution for batch production within the VirusExpress® 293 AAV Production Platform.
• Licensing framework: Licenses are available for research use or for clinical and commercial use.

Technical Specifications

• Cell culture medium: EX-CELL® CD HEK293 Viral Vector Medium (14385C)
• GMP regulations: 21 CFR 210, 211, 600, and 610
• Proven production scale: up to 3 L
• Cell growth scale: up to 50 L
• 3 L bioreactor working volume: 2 L
• Target viable cell density: 8 × 10⁶ cells/mL at all assessed scales
• 50 L bioreactor growth point: target viable cell density reached at day 6
• 50 L bioreactor viability: ≥90% after day 6
• 3 L bioreactor growth point: target viable cell density exceeded at day 5
• 3 L bioreactor viability: ≥95% after 5 days
• AAV2 target genome titer: 1 × 10⁹ gc/mL
• AAV2 baseline process genome titer in 3 L Mobius® Single-use Bioreactor: 9 × 10⁹ gc/mL average across 3 production runs
• Planned AAV2 genome titer enhancement: target of at least a 6-fold increase, from 9 × 10⁹ gc/mL to approximately 5 × 10¹⁰ gc/mL
• Estimated clinical manufacturing start timeline: as little as 6 months using the VirusExpress® 293 Production Platform
• Custom cell line and process timeline comparator: ~3 years for development of a custom cell line and process
• Experience referenced for viral vector manufacturing and gene therapy manufacturing: 30+ years

Applications and How the VirusExpress 293 Production Platform Is Used

• AAV vector manufacturing: Used as a transfection-based platform for suspension-based AAV production with an upstream process optimized for scalable manufacturing.
• Lentivirus production: Used as a transfection-based platform for suspension-based lentiviral production with a scalable upstream process.
• Transient transfection workflows: The AAV platform is used with optimized medium for transient transfection and triple plasmid transfection conditions for AAV2 production.
• Bioreactor process development and scale-up: Used for process development from shake flasks to 3 L and 50 L Mobius® Single-use Bioreactor scales.
• AAV2 production: The baseline AAV process is used to produce AAV2 in a 3 L Mobius® Single-use Bioreactor with a 2 L working volume.
• Multiple AAV serotypes: The platform has been used for production of GFP model virus in AAV2, AAV5, and AAV6 serotypes in shake flasks using baseline process conditions.
• Shake flask and stirred tank formats: Supports high viral titers in both shake flask and stirred tank bioreactor formats.
• PEI-based transfection processes: The HEK293 VirusExpress® Cells for AAV and HEK293T VirusExpress® Cells for lentivirus were selected for higher production using PEI-based transient transfection methods.
• Batch production processes: EX-CELL® CD HEK293 Viral Vector Medium is used in batch production within the VirusExpress® 293 AAV Production Platform without requiring a posttransfection exchange, enhancer, boost or feed.
• Other HEK293 and HEK293T viral vector workflows: EX-CELL® CD HEK293 Viral Vector Medium is also suitable as a stand-alone medium for HEK293 and HEK293T cell lines used for AAV, lentivirus, and adenovirus manufacturing.

Chemical Express, with over 23 years of expertise and as Thailand’s official Merck distributor, provides the full range of VirusExpress 293 Production Platform solutions and related VirusExpress® platforms. Purchase the VirusExpress® 293 Production Platform and other Merck bioprocessing products with confidence through Chemical Express for trusted support and regulatory-ready products.