Gene-Modified Cell Therapy

Gene-Modified Cell Therapy Manufacturing Solutions

Gene-modified Cell Therapies enable unique approaches to novel treatments. After collection of cells from patients the genes are edited ex vivo to boost their function and persistence before they are re-administered into the patients body. This includes CAR-T (chimeric antigen receptor) therapies.

The manufacturing process for gene-modified cell therapies comes along with challenges during fluid and cold chain management. It is of utmost importance to rely on safe cold chain solutions and handling processes for both drug products and vector products.

Mistakes during filling process for cell and gene therapies

Fluid Management Solutions around Single-Use Technologies for Gene-Modified Cell Therapies

Discover Single Use Support's range of solutions for reliable cold chain management, automated drug substance dispensing and filling and logistical handling for cell therapy and vector product developers and manufacturers.

Freezing and thawing at controlled freezing rate is essential to achieve minimized cell damage and maintained cell viability after thawing gene-modified cell therapies. Furthermore, automated liquid transfer, aliquotation, storage and shipment solutions facilitates safe and standardized handling of personalized therapies at different scales and accelerate turnaround times until readminstration.

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.

RoSS.FILL CGT
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.

Industry 4.0 biomanufacturing RoSS.KSET for CGT bag protection
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

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

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.

ross-ship-single-use-full-shipment-service

More Information

Cell and gene therapy

Cell and gene therapy: In vivo and Ex vivo in comparison

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Ex Vivo and In Vivo are two different approaches you will learn about in this article!

RoSS.KSET_Frozen (3 von 5)-min

General chances and challenges of a personalized therapy approach: CAR-T cell therapy

The term CGT stands for Cell and Gene Therapy and describes a range of new personalized therapies that are promising in the treatment of some diseases. For which diseases is the therapy suitable?

Car-t manufacturing process and the supply chain behind it

CAR-T manufacturing process and the supply chain behind it

Mastering the complex CAR T manufacturing process and the associated supply chain challenges in the cell and gene area are the major bottlenecks during the large-scale commercialization of highly promising CAR T cell products.