Automate & Close
CGT Processes
Next-gen solutions for safer, scalable CGT manufacturing
As cell and gene therapies (CGTs) progress from discovery to commercial delivery, the need for automation, safety, and consistency becomes critical. Open systems increase risk, variability, and labor costs, especially in cleanroom environments. That’s why BioLife Solutions offers a suite of closed-system cell processing tools to help therapy developers and CDMOs streamline workflows, reduce contamination risk, and improve scalability.
Why closed-systems
matter in CGT
Open processing – such as pipetting, aliquoting, or transferring fluids in biosafety cabinets – limits scalability and increases the chance of contamination or human error. Closed-systems reduce operator dependent risks, lower cleanroom requirements, and support compliance with GMP and regulatory standards.
BioLife’s platform of tools for automating and closing CGT processes is designed to support:
- Aseptic fluid transfer without biosafety cabinets
- Hands-free aliquoting and fill/finish processes
- Scalable cryopreservation and storage workflows
Integrated solutions to automate and close your workflow
CellSeal® Cryovial
Engineered for cryogenic integrity
CellSeal Cryogenic Vials are purpose-built rigid primary containers for small-volume CGT materials. Hermetically sealed access ports are designed to maintain container-closure integrity at −196°C, with 2 mL and 5 mL options and swabbable or capped Luer-compatible ports. Vials can be filled manually or on high-throughput systems; all product-contact materials are USP Class VI and each lot ships with a Certificate of Compliance.
The CellSeal Cryogenic Vials have demonstrated:
- Maintained integrity after freezing, LN₂ storage, frozen transport, and thaw, meeting dye, and bacterial immersion criteria
- Safe handling while frozen with a design that helps prevent sample leakage
- Microbial barrier venting to enable fill and withdrawal at atmospheric pressure
- High product recovery via a conically shaped retrieval port; ports accept syringes, pipettes, or needleless Luer fittings
- Compatibility with the Signata CT-5® fluid management system and ThawSTAR® CSV automated thawing units
Signata CT-5®
Automated aliquoting for high-value cell products
The Signata CT-5 is a compact, benchtop system that enables automated, aseptic filling into vials (CellSeal® Cryogenic Vials) without the need for a biosafety cabinet. With its intuitive touchscreen interface, pre-configured fill bioprocessing, and compatibility with closed tubing sets and cryo-bags, the Signata CT-5 minimizes operator intervention and enhances repeatability.
Key benefits:
- Reduces cleanroom footprint
- Enhances batch reproducibility
- Lowers operator time and error
CellSeal® Connect
Seamless, closed-system transfer
CellSeal Connect advances the CellSeal platform with a weldable fill and retrieval tube. Designed for the closed-system introduction of intermediate reagents for activation, transduction, and expansion, these vials allow fill and retrieval in a closed manner via sterile welding onto downstream processing systems.
Applications:
- Mid-process sampling
- Final and intermediate product fill/finish
- Preserved cell transfer
CellSeal® CryoCase
Redefining cryostorage standards
The CellSeal CryoCase is a rigid, cryopreservation container designed for cell and gene therapy storage. It’s the first rigid container engineered for closed-system fill and retrieval of larger volumes of fluid (<75 mL). Its importance lies in addressing limitations of traditional cryobags, particularly the presence of particulates and the risk of leaks and fractures.
The CellSeal CryoCase has demonstrated:
- Low particulate burden
- Improved inspectability
- Compatibility with closed-system processing
- Versatility with fill volumes
- Durability unseen before in primary container storage
Ready to close and automate your workflow?
Connect with
our experts
Or request a
demo today
Move beyond the
biosafety cabinet
With BioLife’s integrated platform, you can now safely process and transfer cell therapy products outside of the biosafety cabinet—without sacrificing sterility. Together, Signata CT-5, CellSeal Connect, and CellSeal CryoCase form a fully closed, automation-friendly system from fill to freeze.
Close the loop.
Scale with confidence.
Whether you’re preparing clinical trial batches or scaling for commercial delivery, BioLife’s closed-system innovations help you reduce risk, accelerate timelines, and ensure the highest quality of care.
