At the very early stage of biopharma drug substance manufacturing, the cell banking during upstream processing (USP) in biopharma manufacturing, cells are being nurtured from 1 mL to more than 2000 L within approx. 5 weeks. There are many potential pitfalls in terms of sterility and appropriate cell perfusion when it comes to growing cell lines to their full potential.
Seed train intensification is a way to circumvent the continuous “back to start” with 1 mL and to benefit from the already expanded cells into bioreactors.
SEED.STREAM, the process solution by Single Use Support for advanced seed train intensification, describes the next generation of cell culture intensification. This process includes end-to-end qualification during filling, freezing, thawing and draining of drug substance at all scales.
Automation, process control and high cell density cryopreservation in order to secure protection and sterility by process in a closed system. The advanced process strives to
If you want to be on the safe side when growing a beautiful flower, you’d also rather plant seedlings instead of casting seeds.
Primary Packaging
Feed Source for Aliquotation
Automated Aliquotation
Protect
Controlled Rate Freezing
Ultra-Cold Storage
Transportation
Thaw
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.
Fully automated filling system for multiple small single use bags at highest accuracy. Applicable for both, cell & gene therapies and Upstream 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.
With either RoSS or RoSS.KSET, the sensitive single use bag can be protected as intermediates in Seed Train Intensification. It is covered in 3D foam on the inside and stainless steel on the outside - ideal for controlled freezing process and absolutely robust.
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 freezing and thawing of small batches - more important than ever for seed train intensification. The plate-based freeze & thaw platform for labs 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.
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 240L 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.
