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’ demands in this regard:

  • Primary packaging (suitable for cryopreservation)
  • Fluid management Solutions
  • Cryogenic Freezers 
  • Ultra-Cold Storage Freezers
  • Shipping Containers

Together, these products comprise an elaborate product array designed to facilitate the medical breakthroughs enabled by viral vectors. 

viral vectors gene therapy 3 aav

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
  • AAVsadeno-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

cgt-single-use-bag-primary-packaging

Primary Packaging

RoSS.PADL

Feed Source for Aliquotation

RoSS.FILL CGT

Automated Aliquotation

Protection for small single use bags CGT with RoSS.KSET

Robust Protection

Plate freezer Biopharma large scale with RoSS.pFTU

Controlled Freezing

icons-e2e-stream_RoSS.FRDG

Cold Storage

Shipping drug substances in single-use bag containers safely with RoSS.SHIP

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.

Single-use bioprocess container by Single Use Support

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.

RoSS.PADL Product

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.

Automated filling and draining system for CGT - RoSS.FILL CGT
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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.

RoSS.FILL CGT Lab Scale_product photo (2 von 10)
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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.

Aseptic bag filling machine RoSS.FILL

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.

RoSS shell protecting single use bags open

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.

Plate freezer biopharma with RoSS.pFTU midscale
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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.

RoSS.LN2F_Product Photo in Progress-4

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.

RoSS.pFTU Lab Scale_Product Photo
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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.

Plate freezer biopharma large scale freezing with RoSS.pFTU largescale

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.

Ultra-cold storage RoSS.FRDG

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.

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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
Guide_Navigating 5 Overlooked Challenges in Viral Vector Manufacturing_Single Use Support

Navigating 5 Overlooked Challenges in Viral Vector Manufacturing

Filesize: 1.21 MB – Mime-Type: application/pdf

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Safe handling AAVs

Safe handling & Storage of Viral Vectors

Viral vectors like Adeno-associated viruses (AAVs) are popular vectors for gene therapy and vaccines. And yet, there is product loss due to leakages of primary packagings or other mishandling of fluids. In order to deliver high-quality and viable products efficiently, safe handling experience a growing interest.