Close the open steps. Protect the batch.
A closed, sterile, family of devices that keeps cell and gene therapy processes closed from initial steps to final fill so you can scale safely, and protect every dose.
See it in action
Commercial cell therapy products
Late-stage clinical trials
Early-stage clinical trials
The problem
Manual, open transfers during reagent and media addition, bead addition, sampling, and vial-to-bag steps expose high-value cell products to contamination. Closing those steps usually means more biosafety cabinet time, and longer operator training. When a batch can be worth six or seven figures, one open connection can cost you the batch.
Every open connection is a point where the batch can be compromised.
Biosafety cabinets and Grade A cleanroom space are expensive to build and run.
High-value cells and media are lost to spills, dead volume, and failed transfers.
Complex aseptic technique takes long training curves to perform consistently.
Why it matters
Close steps without adding biosafety cabinets or Grade A space.
A closed path to and from vials, bags, and bioreactors.
Run closed steps where your process needs them.
Minimal training; teams are productive fast.
Single-use devices, no large equipment to house.
Intuitive connections, luer-lock or sterile weld.
Across your process
Closed, versatile solutions with sterile-weld and luer connectors across the whole workflow, from vial to final fill.
Product attributes
Sealed and isolated from the environment; integrity-tested before shipping.
Pre-sterilized by a validated method; hydrophobic filter keeps the pathways sterile.
Prevents release and ingress of microbes and biological agents.
No cross-contamination between runs.
To vapors and cleanroom disinfectants, liquid or VHP.
Validated.
How it works
Vial Adaptor to vial, Syringe Unit to adaptor. No exposed needle or septum.
Withdraw cells or media into the closed-back Syringe Unit.
Air moves through a hydrophobic filter; fluid and air pathways stay separate and sterile.
Sterilized air releases to balance pressure inside the closed system.
Move fluid on via Luer Lock Adaptor or a sterile weld to a cell therapy bag.
Pull off cleanly; repeat for aliquoting, e.g. bulk bag to multiple vials.
The plunger is encapsulated and can’t be detached, which closes the syringe inner-wall route that standard syringes leave exposed.
Product family
Every part connects by luer-lock or sterile weld, so the system stays closed end to end.
Closed-back, encapsulated plunger. From 1 mL for QC samples to 60 mL for bulk transfer — one closed system.
Telescoping spike, hydrophobic barrier. Multiple vial sizes.
In-process and CQA sampling. Cell and media transfer, mixing, and air removal.
Syringe-to-bag and mating connections.
Proof & validation
Microbial ingress / media fill validated under ISO 8 (ISO 14644-1) conditions.
volume loss — a leading cell therapy CDMO, from the CellSHIELD launch.
In use across 3 commercial products, 3 late-stage and 20+ early-stage CGT programs.
The validation and volume-loss data behind CellSHIELD, in one document.
— Representative, leading cell therapy CDMO
Resources
The CellSHIELD family and specifications.
Current instructions for use, online.
Industry blog posts.
FAQ
Closed-back, non-detachable plunger; air and fluid pathways stay fully separate; rear-chamber air passes through a hydrophobic filter. This closes the syringe inner-wall route that open, standard syringes leave exposed.
The handling sequence depends on the connection. A cell therapy specialist can confirm the correct sequence for a sterile weld with your setup.
The filter will be removed during the welding process. A cell therapy specialist can confirm the correct sequence for a sterile weld with your workflow.
Yes. A Certificate of Analysis and Certificate of Conformance are provided with product, and lot-specific documents are available on request.
Yes. Instructions for use are available digitally; your specialist can share the current access path for CellSHIELD.
What sizes and connections are available?
Syringe Units and Sampling Kits are available from 3 mL to 60 mL, with luer-lock or sterile weld connections depending on the part.
Because the system stays closed, it is designed to reduce reliance on biosafety cabinets and Grade A space. Talk to a specialist about the right setup for your process.
Contact us to request samples for your process, and speak to an expert.
