Pristal is a dual-chamber syringe (DCS) that reconstitutes lyophilized biologics from two independent, standard cartridges — no stacked DCS geometry, no specialty fill-finish infrastructure. Just remove the cap, agitate, and dose.
The Problem
The dominant dual-chamber syringe (DCS) architecture stacks lyo and diluent coaxially in one barrel. Despite years of availability, the stacked DCS carries usability and manufacturing compromises that persist no matter how the device is refined.
The eight-step aseptic fill-finish process required by stacked DCS devices
A vented air pocket enables diluent transfer — but depending on device orientation, that same pocket can cause lockout, force spikes, or a sudden doubling of injection force.
Most stacked designs require tip-up lyophilization — a slower, less efficient thermal process that leaves formulation resting against the stopper longer, then require flipping the container mid-process for a second fill stage.
Specialty valves, custom rubber, and non-standard processes mean only a small handful of CDMOs worldwide can run stacked DCS fill-finish at scale — see the numbers below.
The Pristal Solution
Instead of one device with coaxial chambers, the Pristal dual-chamber syringe stores lyophilized drug and diluent in two separate, off-the-shelf cartridges — physically apart until the moment of use, with no possibility of premature mixing.
Removing the cap triggers an internal spring: needles pierce both cartridges, diluent automatically transfers into the lyo cartridge, and the plunger rises into injection position — no user input required.
The user agitates the device to confirm complete reconstitution, through the same standard method used with vials — visible through the clear housing.
Prime and inject, exactly like a standard prefilled syringe. Because reconstitution already happened, dosing is a single plunger stroke — no air pocket, no bypass, no change in force partway through.
Engineering Detail
Removing the safety cap releases a compression spring that drives the entire reconstitution sequence to completion in seconds — with no timing, technique, or metering left to the user. No vented air pocket, and none of the variable force profile a stacked DCS imposes.
"Because Pristal is built from two independently filled, standard cartridges, it leaves fill-finish, lyophilization, and assembly infrastructure essentially untouched."
Why It Matters
Of roughly 390 global fill-finish CDMOs, about 50 have both lyophilization and cartridge capability. Only about two can run stacked dual-chamber syringe fill-finish at scale — a bottleneck that drives two-year backlogs and exorbitant pricing.
Configuration Options
Because lyo-to-diluent ratio isn't dictated by a fixed dual-chamber geometry, pharma partners set the ratio their formulation needs — not the other way around.
See the full reconstitution mechanism, configuration options, and dual-chamber syringe supply-chain comparison in one document — sent straight to your inbox.
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