Viral Vector Upstream Platforms
Gene therapies in the market today use viral vectors to introduce modified genetic material into targeted cells. This means gene therapy manufacturing starts with the upstream production of vectors either through transient transfection or use of stable producer cell line which culminates in the harvesting of the viral vector produced. This feeds into downstream purification and concentration to ensure the product has high efficacy and safety to pass regulatory requirements. Therefore, making the right upstream process decisions not only impacts immediate upstream outputs, but also downstream processes, timelines and regulatory acceptance.
Four major challenges that face upstream manufacturing today include: High productivity, process robustness, scalability for commercial production, and product quality. Using optimized, time-effective upstream production platforms can help gene therapy manufacturers address key upstream challenges. Draw on our experience to learn how you can speed your gene therapy to patients.
Lentivirus Manufacturing:
Are you looking for a platform that achieves best-in-class performance for lentivirus production?
- The VirusExpress® 293T Lentiviral Production Platform offers a transfection-based solution to lentiviral (LV) production challenges, featuring a suspension adapted cell line, chemically defined medium, and process with proven performance at 50 L scale.
Adeno-associated Virus (AAV) Manufacturing:
Are you an AAV manufacturer looking for a high quality, high performance upstream platform?
- The VirusExpress® 293 AAV Production Platform offers a transfection-based solution using a suspension adapted cell line, chemically defined medium, and a clinically relevant process dramatically reducing time to production.
- Sf9 Rhabdovirus-Negative (Sf-RVN®) Platform provides a rhabdovirus-free cell line that improves the safety profile of your bioprocesses combined with a chemically defined medium specifically formulated to get excellent growth and productivity while adhering to regulatory requirements.
Related Product Resources
- Scalability Challenges of Viral Vector Manufacturing
Scaling up viral vector production using adherent cell culture systems is challenging. Learn how suspension cell culture systems benefit large-scale bioprocessing.
- Driving the Viral Vector Expressway: Speeding Through AAV Manufacturing
The production of AAV viral vectors for gene therapy comes with unique upstream challenges. Learn how our HEK platform can solve these challenges.
- Bioreactor Process Development and Scale-Up for Transient Transfection-Based Lentivirus Manufacturing in Suspension Cell Culture
A step-by-step overview of suspension-based, transient transfection bioreactor process development and scaleup of lentivirus production.
- Bioprocessing And Scale-Up Of Suspension HEK293 Cells For AAV Manufacturing
To address scalability challenges of AAV manufacturing, we developed an HEK293 suspension cell line that can be used across many serotypes. Get the data in this article.
- Development of a Novel Sf9 Rhabdovirus-Negative Cell Line (Sf-RVN®) and Companion Chemically Defined Medium
See how the Sf9 rhabdovirus-free cell line was developed and how we’ve developed a companion chemically-defined insect cell media for protein and viral expression.
THE VIRUSEXPRESS® 293T LENTIVIRAL PRODUCTION PLATFORM
The VirusExpress® 293T Lentiviral Production Platform offers a transfection-based solution to LV production challenges, featuring a suspension adapted cell line, chemically defined medium, and process with proven performance at 50 L scale. The platform can dramatically reduce time in process development and scale-up, either within your own facilities or using our contract manufacturing capabilities to speed your therapy to patients.
Key Advantages of VirusExpress® 293T Lentiviral Production Platform Include:
VirusExpress® 293T Lentiviral Production Cells
- Cell line grows to high cell density and viability in suspension and has lower doubling time
- Selected for higher lentivirus production using PEI-based transient transfection method
- GMP-banked and fully characterized HEK 293T cells
- Fully traceable and documentation available for regulatory filings
- Licenses available for research or clinical/commercial use
EX-CELL® CD HEK293 Viral Vector Medium
- Chemically defined, animal component-free cell culture medium
- Supports high cell density and faster growth of HEK293T cells
- Compatible with the PEI based transfection reagents used for viral production
- No need for addition of boost and enhancer reagents for transfection step
- Available in liquid and dry powder formats
Proven Process
- Upstream production process optimized and demonstrated for performance from shake flasks to 50L bioreactor
- Downstream process developed for purification of lentivirus at clinically relevant scale
- Up to 40% reduction in process development and scale-up time
VirusExpress® 293T Lentiviral Production Platform Performance
THE VIRUSEXPRESS® 293 AAV PRODUCTION PLATFORM
The VirusExpress® 293 AAV Production Platform offers a transfection-based solution using a HEK293 suspension adapted cell line, chemically defined medium, and a clinically relevant process dramatically reducing time to commercial production. The VirusExpress® Production Platform offers a higher vector yield than adherent platforms and a simpler process than competitor products. The VirusExpress® Production Platform has been optimized for AAV2, AAV5, AAV6 and other serotype production.
Key Advantages of VirusExpress® 293 AAV Production Platform Include:
VirusExpress® 293 AAV Production Cells
- Cell line grows to high cell density and viability in suspension and has lower doubling time
- Selected for higher rAAV production using PEI-based transient transfection method
- GMP-banked and fully characterized HEK 293 cells
- Fully traceable and documentation available for regulatory filings
- Licenses available for research or clinical/commercial use
EX-CELL® CD HEK293 Viral Vector Medium
- Chemically defined, animal component-free cell culture medium
- Supports high cell density and faster growth of HEK293 cells
- Compatible with the PEI based transfection reagents used for AAV production
- No need for addition of boost and enhancer reagents for transfection step
- Available in liquid and dry powder formats
Proven Process
- Upstream production process optimized and demonstrated for performance from shake flasks to 50L bioreactor
- Downstream process developed for purification of AAV at clinically relevant scale
- Up to 40% reduction in process development and scale-up time
THE Sf-RVN® PLATFORM
For Improving the Safety Profile of Your Baculovirus-Insect Cell Based Vaccines and Gene Therapies
The Sf-RVN® Insect Cell Line offers a rhabdovirus-free alternative and enhances risk mitigation. Together with the chemically defined medium, EX-CELL® CD Insect Cell Medium, forms the Sf-RVN® Platform, providing a high-performance platform optimal to produce adeno-associated vectors (AAV) for gene therapy applications.
Key Advantages of the Sf-RVN® Platform include
Sf-RVN® Insect Cell Line
- Sf9 rhabdovirus-negative cell line
- Adventitious agent tested and GMP banked in EX-CELL® CD Insect Cell Medium
- Full traceability and documentation available for regulatory filings
EX-CELL® CD Insect Cell Medium
- Chemically defined and animal component free
- High reproducibility and lot-to-lot reliability
- Supports growth of multiple insect cell lines
- Optimized for the Sf-RVN® Insect Cell Line
- Available in liquid and dry powdered medium
Benefits
- Improved Safety - Enhanced risk mitigation with the rhabdovirus negative cell line
- High Performance - Optimized to get high low doubling time, high cell viability and high AAV titer
- Flexible Options - Several license agreement options available
- Technical Support - Technical user guide with detailed protocols for optimal performances
Highlights
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