Gene Therapy

Gene Therapy Manufacturing Solutions

Gene therapy – modifications on a patient’s genome, e.g. by integration and activation of new genetic material or the deactivation of disease-causing or faulty genes via a viral carrier – have allowed to set milestones in the therapy of a variety of even rare diseases. But although being applied in a more and more experienced manner also beyond clinical trials, genetic therapies will keep requiring the highest possible diligence.

Single Use Support GmbH provides biotechnology companies with specialized single-use solutions for gene therapies to optimize ATMPs (advanced therapies) manufacturing processes – from sterile single-use systems and customizable liquid management systems up to freezing and storing solutions.

Gene therapy manufacturing
cgt-single-use-bag-primary-packaging

Primary Packaging

RoSS.PADL

Feed Source for Aliquotation

Single-use aseptic bag filling machine RoSS.FILL

Automated Aliquotation

Single-use bag protections system with RoSS shell

Robust Protection

RoSS.LN2F_open

Controlled Rate 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-scaled

Automated Aliquotation

RoSS.FILL

With RoSS.FILL, the RoSS shell systems contained in the bag rack can be filled with a speed of up to 300 liters per hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks.

Cell and gene therapy filling machine with RoSS.FILL CGT system
downscale

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-Lab Scale_Fill & Filtraton Platform

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.

kset_topview_hell-min
upscale

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.

Bulk.Stream RoSS shell

Controlled Rate Freezing

RoSS.LN2F | Liquid Nitrogen 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.

Cryogenic Freezer RoSS LN2F
downscale

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.

Laboratory freezer RoSS.PFTU Lab Scale
upscale

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.

Pharmaceutical freezer RoSS.pFTU large scale freeze thaw platform

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

Shipment at -80°C/-150°C. 100% protection from external mechanical influences and different possible sizes will fulfil your individualized need. Also monitoring temperature and location-tracking are no problems.

ross-ship-single-use-1

Primary packaging for gene therapies

After gene therapy products such as viral vectors have undergone a gene editing process and have been cultured, they are not usually administered immediately. Instead, they must be safely stored ex vivo before they can perform the genetic modification for which they were designed, such as the replacement of a mutated gene or gene transfer.

To ensure the quality and safety of gene therapy products until they are transported to readministration, Single Use Support has developed single-use solutions in different sizes: For instance, RoSS.KSET is designed for the protection of smaller bioprocess containers, such as those needed for gene therapy, where smaller volumes need to be handled.

Solutions

RoSS.KSET top view

ROSS.KSET | Protecting small single-use bags

RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell of our CGT bag protection system is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies.

For larger volumes, RoSS can protect one or multiple single-use bags in one shell.

RoSS shell protecting single use bags open

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

Single-use bioprocess container by Single Use Support

IRIS Single-Use Bioprocess Container

Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS 2D single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from cell culture samples to large drug substance volumes reliably and on time.

Aseptic Filling and Draining of gene therapy products

To make sure that gene therapy works safely and effectively, the products that patients are provided with must be handled in a secure and sterile manner. This also applies to the filling and draining process, where the risk of cross-contamination and exposure to the environment must be avoided at all costs. Therefore, it is advisable to automate fluid management in gene therapies.

Single Use Support has developed dedicated gene therapy liquid solutions for safe and efficient filling and draining processes – the RoSS.FILL platform is the result of these efforts. The devices are available in different sizes, allow for high flexibility while speeding up turnaround time in gene therapy production.

Solutions

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

RoSS.FILL CGT | Fill-Filtration

10mL-500mL: Fully automated cell and gene filling machine system for aseptic filling of multiple small single use bags. Special designed for use in cell & gene therapies with batch sizes at low volumes. With its high filling accuracy, the platform provides filling for up to 36 bags with one rack - having the option to attach more racks.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL Bag | Single-use aseptic bag fill-filtration system

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

Single-use assemblies manifold

IRIS Manifold | Single-Use Assemblies

As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime and ensure an uninterrupted supply chain in compliance with GMP and regulatory requirements with our single-use manifold assemblies using silicone tubing and connectors of your choice.

Controlled Freeze and Thaw processes for genetic therapies

Gene therapy products have very specific requirements for their freeze/thaw conditions, and an uncontrolled freezing process might cause irreparable damage to the product. Viral vectors, for example, are not only best stored at ultra-cold temperatures around -80 °C, but also need to be brought to this temperature at controlled cooling rates as they, too, are crucial to their quality.

Single Use Support has been innovating in this field and developed the RoSS.pFTU platform for optimized freezing and thawing of drug products. Based on plate freezing techniques, our freezers are available in different sizes, therefore suitable for various fields of application – be it the freezing of small volumes with RoSS.pFTU Lab Scale or the handling of larger volumes with the RoSS.pFTU Large Scale plate freezer, achieving temperatures as low as -80 °C. If even lower temperatures are required, the cryogenic freezer RoSS.LN2F can freeze products down to -150 °C.

Solutions

Ultra-cold storage RoSS.FRDG

RoSS.FRDG | Ultra Cold Storage Freezer

RoSS.FRDG is an ultra cold storage fridge for frozen drug substances in different sizes. The ultra cold freezer keeps the desired set point temperature down to -80°C. RoSS.FRDG offers highest storage density, is fully movable and can be modularly adapted to your individual needs.

Cryogenic Freezer RoSS LN2F

RoSS.LN2F | Cryogenic Freezer

RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/ -292°F. An enclosed LN2 system and our innovative direct injection system ensure no direct exposure and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

Laboratory freezer RoSS.PFTU Lab Scale

RoSS.pFTU Lab-Scale | Freeze-Thaw

1mL-10L: Laboratory freezer, compatible with single use bags of all sizes and manufacturers. Our lab freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

Gene therapy products – transport solutions

Before gene therapy solutions can be administered to treat various, often serious diseases such as leukemia or lymphoma, they must be transported and stored until the time they are needed. To ensure that they do not lose quality and safety over the time they are stored ex vivo, gene therapy products require special transport and storage solutions that also take into account the fact that space can sometimes be at a premium, while efficiency is key in cost and resource reduction.

To address this need, Single use Support has developed the ultra-cold storage freezer RoSS.FRDG, being a stackable device compatible with our protective equipment for single-use bioprocess containers, leading to an increased storage density. Additionally, Single Use Support has established RoSS.SHIP – a smart cold chain shipping container, able to keep temperatures below -60 °C for at least six days.

Solutions

Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

RoSS.SHIP secures the cold chain shipping and storing of bulk drug substance for almost one week. Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

Store and ship single use container with Ross Trolley

RoSS.RACK | Transport Devices

RoSS.RACKs are supporting devices for in-plant transport for up to 30 RoSS® shells. Racks can be moved easily either on paletts or as trolleys and smoothen the process between various logistics units, such as from filling RoSS® shells to the bulk substance freeze platform.

More information

Gene therapy manufacturing-5 requirements to scale up

Gene therapy manufacturing - 5 requirements to scale up

Gene therapies have become a highly promising field of groundbreaking next generation treatment, but there are some challenges to face within the manufacturing process. Here are 5 factors that will be crucial for upscaling gene therapy manufacturing with single-use technology.

flcu_5001-flcg_1001-113

Single Use Support providing solutions for gene therapies

Biopharma solution provider Single Use Support announces an order from Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO).