By Kimberly Curtis, Kim Rawlins, Zhou Jiang, and Peggy Lio
Designed to complement our extensive range of single-use Allegro™ biocontainers, the RoSS (Robust Storage and Shipping) technology ensures that valuable fluids within the bags are protected and fully immobilized by the unique shell technology. The complete immobilization afforded by the RoSS shell protects the single-use biocontainer bag throughout the RoSS technology workflow, from automated bulk filling, controlled freezing, safe transportation, and controlled thawing, helping to eliminate leakage and product loss. Plate freezing technology in RoSS shells also ensures identical freezing kinetics from early clinical stage up to commercial manufacturing.
Benefits
- Fully immobilized biocontainers to eliminate leakages throughout the whole workflow
- Minimized manual handling and low possible biocontainer bag/operator exposure
- Plate freezing for controlled freeze and thaw step
- Linear scalability from bench/clinical stage to large-scale/commercial manufacturing
- Tubing management in RoSS shells allows enhanced flexibility in single-use design
- Eliminates leakage and product loss
- Excellent temperature transfer
- Fully pre-qualified and validated
The platform
This linear, scalable platform fills the gap between the downstream and fill/finish process stages by offering an innovative liquid management solution to fill, freeze, transport, and thaw bulk drug substance in Allegro single-use biocontainers.
Protect
The RoSS shell is a robust container that fully immobilizes the Allegro storage single-use system during filling, freezing, transportation, and thawing. The complete immobilization protects the Allegro storage single-use system’s biocontainer bag, tubing, and connectors/disconnectors to eliminate leakage and product loss. The robust shell also delivers excellent temperature transfer for fast freezing or thawing, and its compact form maximizes storage density in cold rooms.
Fill/drain
RoSS.FILL is a flexible platform for dispensing operations into Allegro storage single-use systems for RoSS shells and bulk filtration that are supported by RoSS systems. The fluid path is designed to be fully disposable and can accommodate a variety of sterile connection and disconnection options. Size, shell number, and detailed specifications can be designed according to your individual needs. A modular system with separate control unit and pumping station, it provides a fully automated filling and draining system for Allegro storage single-use systems for RoSS shells, filling up to 200 L in < 1 hour.
Freeze/thaw
ROSS.pFTU is a plate-based freeze-thaw unit for any scale and batch size. Based on plates, the freezing and thawing time is controlled and rapid. Available for use with various sizes of Allegro storage single-use systems for RoSS shells, this plate-based freeze and thaw platform delivers a fast, controlled freeze and thaw step. Both lab-scale and large-scale units are available to accommodate clinical stages up to commercial manufacturing.
Freezing that is too slow results in cryoconcentration — proteins and excipients form concentration gradients near the freeze front and get excluded from the ice-liquid interface. This can lead to pH shifts and phase separation among the components resulting in protein structural damage. However, the RoSS pTFU Large-Scale enables fast freezing (four to ten times faster than conventional blast freezing) and provides excellent product stability.
Store, ship, track, and trace
RoSS.SHIP holds up to 27 RoSS trays in a compact volume. Most frozen substances can be stored and shipped in a protected manner and according to international logistics standards. The single-use RoSS.SHIP container is designed for passive cooling with dry ice or phase change materials (PCM). For peace of mind, the geographical location and interior temperature of the RoSS.SHIP container can be tracked and monitored 24/7 via GPS or G-Force tracking. RoSS.SHIP secures the cold chain storage and shipping of bulk drug substance for one week. Tests have shown that the temperature inside most types of RoSS.SHIP is held below -60 °C for at least six days. Therefore, it is suitable for both short-distance and long-distance transportation including airfreight and international shipping of substances.
RoSS.RACK is a stainless steel trolley developed for safe in-plant transportation and storage of Allegro 2D biocontainers protected by RoSS shells. Designed to store up to 20 RoSS shells and suited for use in cleanrooms and in cooled environments, the trolley can also be easily cleaned and re-used multiple times.
Comparative technologies
| Other freeze and thaw Technologies | Freeze and Go Solutions |
|---|---|
| Accessible bag and tubing: low protection of biocontainer bag, due to required manual handling and tubing | Assured, validated protection: small and robust shell that completely immobilizes the biocontainer bag, tubing, and connectors |
| Leakages during freezing and transportation, typical product loss rate between 1% and 5% | Using Allegro biocontainers in RoSS shells minimizes the loss rate towards 0% |
| Difficult scale-up: poor scalability with blast freezing | Linear scalability |
| Long processing time in blast freezer: blast freezing takes two to five times longer than plate freezing | Controlled and fast freezing in plate freezers in only five to eight hours |
| Controlled environment: freezing in bottles requires handling in a controlled environment (e.g., laminar flow) | Closed system: completely closed single-use system allows operation in uncontrolled environment |
| Non-validated process: lack of shipping validation | Fully validated: full shipping validation according to ISTA and ASTM standards |
| No temperature tracking available | Temperature tracking: optional GPS sensor to live-track product temperature |
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