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!
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.
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.
Feed Source for Aliquotation
Controlled Rate Freezing
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.
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.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks. Fully automated aliquoting into multiple small single use bags at highest accuracy. Applicable for autologous and allogeneic cell & gene therapies.
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.
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.
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.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.
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.
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 adapted to RoSS shell system for a batch sizes of up to 100L.
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
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.
Sterile aliquoting into single-use bags and freezing for cryopreservation of cells pose challenges for laboratories and manufacturers. Download the App Note to learn more about the implications and approaches to address these challenges.