See how custom manifolds enable efficiency in a cryopreservation stage of allogeneic therapy development
The Challenge
A customer was looking for a more streamlined method to overcome three challenges to develop the formulation and filling processes for their cryopreserved working cell bank:
- managing larger liquid volumes within a closed system before moving into their cell expansion stage;
- increasing processing speed; and
- adding additional efficiencies as the process scales to commercialization.
The Process
The customer approached Charter Medical to initiate the process for a new design. They requested that Charter’s single-use experts review their current filling process to understand the gaps they needed to address to implement their desired process. After mapping out the process, the Charter team assessed various bio-container types and custom manifold configurations that the customer could apply. The team then presented a custom assembly drawing to capture these considerations. Upon approval, the Charter team then built and delivered prototypes within weeks to validate the process at the customer’s site.
The Solution
The solution was a custom-designed single-use manifold that connected 10 50mL CryoProtect™ Bio-Containers, pump tubing, and weldable spine tubing. This manifold was designed to fill 10 bags sequentially within a closed system instead of one by one in a highly controlled environment for the working cell lines. The weldable spine tubing allowed for easy connection to the primary bag when switching between manifolds. The CryoProtect Bio-Containers can be frozen down to -196°C and are compatible with DMSO up to 20%, an ideal solution for working cell banks that require long-term cryopreservation.
The Results
The implementation of the 10-bag manifold enabled the customer to perform many of the processing steps in a lower-level-classified cleanroom – which had substantially more usable manufacturing space – to properly scale the allogeneic therapy while still maintaining a high level of sterility via a closed-system solution. The time allotted for the filling process was significantly shortened because the new process eliminated the need to attach, fill, and remove the bags one by one, thus decreasing hands-on operator time.
The Impact
The customer scaled up to larger batch sizes while still maintaining sterility. As development advanced, they were able to configure and implement the same single-use components, helping to reduce process complexity and potential barriers to commercialization.
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