VirusExpress® Lentiviral Production Platform by Merck: Scalable Lentivirus Manufacturing for Gene Therapy

Gene therapy development requires high-yield, scalable lentiviral vector production that meets strict quality standards. The VirusExpress® Lentiviral Production Platform addresses these demands with a transfection-based, suspension-adapted HEK293T cell system, chemically defined medium, and proven scalability at 50 L, supporting a streamlined path from research to clinical application.

Why Choose the VirusExpress® Lentiviral Production Platform

• Faster process advancement: Reduces time in process development and scale-up by approximately 40%.
• Proven manufacturing performance: Demonstrates proven process performance at 50 L scale with functional titer exceeding 4 × 10⁷ TU/mL.
• Accelerated therapy timelines: Supports faster delivery of therapy to patients.
• Operational flexibility: Can be implemented in your own facilities or through contract manufacturing capabilities.
• Regulatory support: Provides robust quality documentation to support regulatory filings and commercialization.

VirusExpress® Lentiviral Production Platform: Components and Key Features

• Upstream production architecture: Transfection-based solution configured for lentiviral upstream production.
• Cell line component: Suspension-adapted 293T lentiviral production cells form the cell line element of the platform for production of lentiviral vectors for gene therapy applications.
• HEK293T Cell Characteristics: HEK293T VirusExpress® Cells grow in suspension to high cell density and viability with low doubling time.
• Transfection compatibility: HEK293T VirusExpress® Cells were selected for higher lentivirus production using a PEI-based transient transfection method.
• Medium Component: EX-CELL® CD HEK293 Viral Vector Medium is a chemically defined, animal component free medium without L-glutamine.
• Process Documentation: Comprehensive user protocols guide the workflow from seed train through at scale transfection and virus production.
• Cell Bank Status: The cell bank is GMP banked and fully characterized in accordance with FDA cGMP regulations.
• Safety Testing: HEK293T VirusExpress® Cells are adventitious agent tested.
• Regulatory support documentation: The platform includes full traceability and quality documentation to support regulatory filings and commercialization.
• Use rights: Licenses are available for research, clinical, and commercial use, depending on the phase of gene therapy development.
• Manufacturing Access: The platform can be used within your own facilities or through contract manufacturing capabilities.

VirusExpress® Lentiviral Production Platform: Technical Specifications

• Proven process scale: 50 L
• Functional titer: exceeding 4 × 10⁷ TU/mL
• Cell storage temperature: -196 °C in liquid N2 vapor phase
• Medium storage temperature: 2 to 8 °C
• EX-CELL® CD HEK293 Viral Vector Medium package size: 1000 mL in bottle
• EX-CELL® CD HEK293 Viral Vector Medium package size: 10 L in bag

Applications and Intended Use of the VirusExpress® Lentiviral Production Platform

• Lentiviral upstream production: Supports transfection-based lentiviral upstream production for suspension workflows.
• Gene therapy vector manufacturing: Supports production of lentiviral vectors for gene therapy applications using optimized 293T Lentiviral Production Cells.
• Research to clinical application: Can be applied across gene therapy development needs with licenses available for research, clinical, and commercial use.
• Process progression: Supports workflows from seed train through at-scale transfection and virus production, with comprehensive user protocols for scale-up guidance.
• Regulatory-supported programs: Suitable for programs requiring documentation to support regulatory filings and commercialization of gene-modified cell or gene therapies.

Products Included in the VirusExpress® Lentiviral Production Platform

With over 23 years of expertise, Chemical Express is the official distributor for Merck in Thailand, offering the VirusExpress® Lentiviral Production Platform and related solutions. Rely on our trusted service to obtain Merck and partner products, ensuring your bioprocessing needs are fully met with quality and regulatory assurance.

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