App Note: Cell Monolayer Cryopreservation
Advanced cell-based assay workflow with CryoLogyx Thaw and Test pre-plated cell and controlled, scalable freezing process solution RoSS.pFTU to achieve effective cryopreservation of cells.
In the process of creating new drug compounds cells play an important role. However, handling of cells requires very careful and fast processes in order to guarantee best-possible quality.
When cryopreserving cells it is crucial to achieve a high cell recovery rate and ultimately optimal cell viability after thawing. Controlled cGMP-compliant and scalable freezing enables reprodicible processes and thus standardization. Study results confirm a consistent and uniform high ratio of live cell recovery after cryopreservation of cells in single-use bioprocess containers thanks to plate-based RoSS.pFTU Lab Scale leading to accelerated cell-based process workflow.
State-of-the-art single-use technologies improve fluid management and cold chain management of cell significantly. Elaborated solutions accelerate the process of aliquoting and freezing cells to less than 1 hour whilst providing full control over accuracy during automated aseptic dispensing and controlled freezing with liquid nitrogen down to -180°C (-292°F).
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 filling system for multiple small single use bags at highest accuracy. Applicable for both, cell & gene therapies and Upstream Seed Train Intensification.
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.
With RoSS.FILL Bag, the RoSS shell systems contained in the rack are filled with a speed of up to 200L 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.
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 completely adapted to RoSS shell system for a batch sizes of up to 400L and more.
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
RoSS.SHIP secures the cold chain storage and shipping of bulk drug substance for almost one week. With its Smart Tracking & Tracing Add-on you never loose control of your product.
The plate-based platform for controlled freezing and thawing small batches, RoSS.pFTU Lab Scale, is the perfect solution for cell culture intensification in intermediates of one or multiple single use bags of up to in total 5L. GMP-compliant computerized system optional.
RoSS.pFTU Mid Scale is a plate-based freeze-thaw unit for studies and small scale batches. Thawing different individual volumes of drug substance up to 70 L with ease. Based on plates, the freezing and thawing time is controlled and rapid.
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.