The fluid management process for mRNA, pDNA and viral vectors for cryopreservation are often performed manually and in an uncontrolled manner. As a result, they are prone to inefficiencies and increased product loss. Learn how modular and flexible single-use technologies optimize the manufacturing process in the following App Note.
Viral Vectors
Viral Vector Production
With the discovery of new fields of application for viral vectors in gene therapy comes an increased need for dedicated solutions in manufacturing and supply chain. Single Use Support has a wide product portfolio ready to meet manufacturers’ needs for:
- Primary packaging (suitable for cryopreservation)
- Fluid management Solutions
- Cryogenic Freezers
- Ultra-Cold Storage Freezers
- Shipping Containers
They will help you navigate the challenges and pitfalls to facilitate the medical breakthroughs made possible by viral vectors.
Most common Viral Vectors
Automated and modular single-use technology solutions bring a variety of advantages viral vector manufacturing processes, such as a high level of safety and cost and resource efficiencies. The most common viral vectors our products are used for are:
- AVVs – adenoviral vectors, i.e. vectors based on adenoviruses
- AAVs – adeno-associated viral vectors (AAV vectors)
- LVVs – lentiviral vectors, i.e. vectors based on lentiviruses
- RVVs – retroviral vectors, i.e. vectors based on retroviruses
Scalable Single-Use Technologies for Viral Vector Processes
Primary Packaging
Feed Source for Aliquotation
Automated Aliquotation
Robust Protection
Controlled Freezing
Cold Storage
Shipping
Primary Packaging
IRIS Single-Use Bag (2D or 3D)
Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.
Feed Source for Aliquotation
ROSS.PADL | HOMOGENIZING SOLUTION
RoSS.PADL is a platform to standardize cooling of your single-use bag whilst gently massaging it to ensure a homogeneous mixture of your substance.
Automated Aliquotation
RoSS FILL
With RoSS.FILL, bags can be filled at high throughput and unprecedented filling accuracy in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up to more than 300L filling volume or scaled out to 100+ smaller bags.
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RoSS.FILL Lab Scale
Accuracy is key: Fully automated platform system for aseptic filling of up to 12 single-use bags in standard configuration and is extendable to higher bag quantities. Most suitable for filling small volumes in cell & gene therapies or seed train intensification.
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RoSS.FILL Bag
RoSS.FILL Bag can dispense up to 300L in 1 hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can include filtration and PUPSIT prior to aliquotation.
Robust Protection
RoSS.KSET
Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.
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RoSS® Shell
With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel – ideal for the freezeing process and absolutely robust.
Controlled Freezing
Controlled Plate-Based Freezer (-80°C)
The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability this cGMP compliant platform enables full control over freezing with optional connection to your MES. The plate freezer RoSS.pFTU Mid Scale is adapted to single-use bags in RoSS shells and RoSS.KSET with smaller volumes of 1L and less for a batch sizes of up to 100L.
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RoSS.LN2F | Cryogenic Freezer
RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/-292°F. An enclosed and innovative platform system for dosed freezing for cell and gene therapies enables no direct exposure, and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.
Lab Scale Controlled Plate-Freezer (-80°C)
Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 10L. GMP-compliant computerized system optional.
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Large Scale Controlled Plate-Freezer (-80°C)
The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch sizes of up to 400L and more.
Cold Storage
RoSS.FRDG | Cold Storage
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
Shipping
RoSS.SHIP
Storage at -80°C/-150°C & shipment. 100% protection from external mechanical influences and different possible sizes will fulfil your individualized need. Also monitoring temperature and location-tracking are no problems.
Navigating 5 Overlooked Challenges in Viral Vector Manufacturing
Learn more about navigating these 5 overlooked challenges in Viral Vector Manufacturing with regards to fluid management challenges thanks to modular and flexible single-use technologies:
- Scalability in Cell Line Development
- Filling Accuracy in Bag Aliquoting
- Viscosity in Liquid Transfer
- Product Viability after Freezing & Thawing and Cryopreservation
- Bag Breakages in viral vector storage and shipping
