Applications · Ex utero development

Life is about to start
outside the body.

Artificial womb and ex utero programs are moving from experiment to reality. Each depends on a sterile, continuously renewed fluid environment, moved gently and precisely for weeks at a time. It is the same problem we solve every day for the most fragile biologics.

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INTERPHEX Exhibitor Awards 2026 winner, Best Technology InnovationINTERPHEX 2026 award winner, Best Technology Innovation

What does an artificial womb need from its fluid system?

An artificial womb keeps a developing organism in a sealed bag of synthetic amniotic fluid that is recirculated around the clock, while gases and nutrients are exchanged through a separate circuit, much like a placenta. That fluid path has to stay closed and sterile for weeks, recirculate gently at a low and steady pressure, deliver precise flow at milliliter scale, and fit a bag geometry built for the program. In practice, the fluid system is the life support.

The challenge

The fluid path
is the life support.

Closed and sterile, for weeks

One breach ends the run. The fluid path must be single-use, sealed and built clean.

Gentle, continuous recirculation

Synthetic amniotic fluid is recirculated around the clock, today often by pumps that squeeze tubing on every turn.

Steady, low pressure

Held near natural amniotic pressure, with no pulsation or pressure spikes.

Precision at small scale

Small-animal models start at milliliters, and must scale up from there.

Custom geometry, every time

Every program needs its own bag geometry, ports and connections.

What we provide

A bag, a pump and a system,
designed as one fluid path.

Dymaxion 2.5D single-use bag, front and side views, showing hanger, custom ports, sanitary clamp outlet and tapered base HangerCustom port layoutSanitary clamp outletHanger sleeveTapered 2.5D base

Custom single-use bags, made in our own cleanroom

  • Tapered 2.5D base. Fluid drains to a single low point at the drain port, for full recovery and smooth flow into the pump.
  • Your geometry, your ports. 2D, 2.5D and 3D formats, with port layouts, tubing and sterile connectors configured for each program.
  • USP Class VI film. Multi-layer film with an inert polyethylene contact layer, 13.5 mil (0.34 mm) thick.
  • Protected by five granted patents. Designed, cut, welded and assembled by hand in our own cleanroom, from first prototype to repeat supply.
More on our single-use bags ›
PIXER single-use diaphragm pump with inlet, outlet and injection lines

PIXER®: gentle, precise pumping for living systems

  • Gravity-fed inlet. Fluid arrives under positive pressure. The pump never pulls, so there is no suction-side cavitation.
  • Low pulsation. An odd number of diaphragms keeps flow and pressure steady. No tubing is squeezed, so nothing wears or sheds into the fluid.
  • Precision at small scale. Linear, repeatable flow from under 1 mL/min, with turndown up to 3,000:1.
  • Mixing and metered additions. Injection ports add nutrients and other components directly into the flow.
More on PIXER® ›
Complete systemsBags, PIXER® pumps, valves, sensors and control designed together as one closed, single-use fluid path, with real-time data on how it is performing. The bag's drain port feeds the pump inlet by gravity, so the fluid is never pulled.

The control layer · Powered by ConSynSys

Weeks of life support.
Nothing left to chance.

An ex utero run cannot be watched by hand for weeks. ProCaaSo®, the cloud-native process control platform from our sister company ConSynSys, automates the whole fluid path, holds flow and pressure where the program needs them around the clock, and gives the team a live view of every reading, every alarm and every change across the whole run.

±0.1 PSI

Steady, around the clock

Pump speed, valves and pressure are controlled together from live sensor data. In a demonstration run on our TFFi™ system, pressure held within ±0.1 PSI of setpoint.

See everything, miss nothing

Every flow, pressure, alarm and intervention is recorded as contextual data. Trends stay visible over weeks, and alarms flag drift before it becomes a problem.

Keeps running if the network drops

Control runs locally on an edge device and continues for up to seven days without a cloud connection. Research data stays in your own single-tenant, zero-trust cloud environment.

Full walk-away automation

Recirculation, exchange and additions run as ISA-88 recipes, start to finish, the same way every time. The system holds setpoints, logs every step and alerts the team when it needs them, so people supervise the run instead of tending the pump.

Every variable under control. Every reading on record. Every run a step forward.

ProCaaSo® does not just switch a pump on and off. It runs every device in the fluid path as one coordinated system, and turns everything that happens into data your team can see, trust and use.

What you control

Down to the setpoint

  • Sub-second response. The control loop is designed to react in under a second, so a change is corrected before it builds.
  • Flow. Pump speed adjusted continuously in closed loop from live flow and pressure readings.
  • Pressure. Proportional valves positioned automatically to hold the setpoint, not just opened and closed.
  • Additions. Nutrients and other components metered through PIXER® injection ports at the ratio you set.
  • The protocol. Every step, setpoint, duration and endpoint defined once as an ISA-88 recipe and run identically every time.
  • Limits and responses. Alarm thresholds on every reading, with automatic actions when something drifts.
  • Changes. Any adjustment made by an authorized user, with who, what and when recorded in the audit trail.

What you see

The whole run, in context

  • Live trends. Every sensor, pump and valve, updated in real time on one screen.
  • Complete history. Time-series data for the whole run, from the first minute to the last, kept in one place.
  • Context, not just numbers. Each reading is tied to the recipe step, setpoint and equipment that produced it.
  • Alarms and events. A timestamped log of every alarm, intervention and state change.
  • Run records. Batch records and reports generated automatically, ready for your lab notebook or quality system.
  • Data you can use. A central, curated data repository, ready for analysis across runs and programs.

What it enables

Better science, with less effort

  • Reproducible runs. The same protocol runs the same way across runs, rigs and sites, so results can be compared with confidence.
  • Faster learning. Every run adds to one searchable record, so the team can see what changed and why outcomes differed.
  • Early warning. Drift shows up in the trend before it becomes an event, while there is still time to act.
  • Fewer people on night watch. Walk-away automation and alerts mean the team supervises the run instead of sitting beside it.
  • Scale without starting over. A protocol proven in a small-animal model carries forward to larger ones as the same recipe.
  • Evidence that stands up. Complete, contextual records support publications, partner reviews and the path toward regulatory submissions.

Cloud-connected. Secure by design.

See the run from anywhere, with bank-grade security behind it.

Control runs in real time at the edge, right next to the fluid path. The cloud adds what a bench controller cannot: a live view of the run from anywhere, every reading kept in one place for the whole program, and room to grow from one system to a facility. All of it sits on the kind of security architecture banks rely on to protect financial data.

Zero-trust architectureNothing is trusted by default. Every connection is verified and encrypted over a single, locked-down port and protocol.
Your data stays yoursEach customer runs in its own single-tenant private cloud on AWS. Data never leaves your environment.
Edge first, cloud smartReal-time control never depends on the internet. If the connection drops, control carries on locally for up to seven days.
Visibility from anywhereAuthorized team members can follow every flow, pressure and alarm live, without being at the bench.
INTERPHEX 2024 Efficiency ChampionFirst PLC replaced by cloud-native control in live productionSub-second controlFull walk-away automationZero-trust, bank-grade security
Explore ProCaaSo® Visit ConSynSys ›

ProCaaSo® is developed by our sister company, ConSynSys Technologies.

How we work with you

From your model
to a working fluid path.

01

Understand the model

Volumes, flows, pressures, run length and scale-up path.

02

Prototype

Custom bags from our cleanroom and a fluid circuit sized to your model.

03

Iterate

Fast design turns as your program learns.

04

Scale

One architecture from small-animal models to larger ones.

Why Alphinity

Built for the most
fragile fluids we know.

Our equipment was designed for viral vectors, mRNA and cell therapies: products that lose potency when they are pumped too hard, pulsed or exposed to cavitation. The principles that protect a fragile biologic, a flooded inlet, steady flow, no squeezed tubing and a closed single-use path, are the same ones a living system depends on.

Our TFFi™ system, built on the same pump and fluid path, won Best Technology Innovation at INTERPHEX 2026.

Technician in cleanroom gown, hairnet, beard cover and gloves assembling a single-use bag by hand
Every bag is assembled by hand in our own cleanroom.

FAQ

Common questions

What equipment does an artificial womb need?

An artificial womb needs a sealed single-use bag to hold synthetic amniotic fluid, a pump to recirculate that fluid continuously, a way to add and exchange fluid and nutrients, and sensors and control to hold flow and pressure steady. A separate circuit handles gas and nutrient exchange through the umbilical vessels. The whole fluid path has to stay closed and sterile for weeks.

What kind of pump is best for recirculating fluid in an artificial womb?

A gentle, low-pulsation pump that is precise at small flow rates and uses a closed single-use fluid path. A gravity-fed inlet avoids suction-side cavitation, an odd number of diaphragms keeps flow and pressure steady, and a diaphragm pump avoids squeezing tubing, so there is no tubing wear or particle shedding.

Can Alphinity make custom bags for artificial womb research?

Yes. Alphinity designs and makes custom single-use bags in its own cleanroom, on bag technology protected by five granted patents. Geometry, volume, port number and port location are designed around each program, from first prototype to repeat supply.

How small a flow rate can PIXER pumps deliver?

The PIXER platform delivers linear, repeatable flow from under 1 mL/min, with turndown of up to 3,000:1, so the same pump architecture can serve small-animal models and scale up from there.

Can nutrients or other components be added directly to the recirculating fluid?

Yes. PIXER pumps can be fitted with injection ports that meter additional components directly into the flow inside the pump, so nutrients and other additions are mixed as the fluid is pumped.

Is Alphinity equipment approved for clinical artificial womb use?

No. Alphinity equipment is available to research and development programs. Alphinity works with partners on the regulatory pathway for clinical applications.

How is an artificial womb fluid system controlled and monitored?

Alphinity fluid systems can run on ProCaaSo, the cloud-native process control platform from sister company ConSynSys. It holds flow and pressure steady from live sensor data, records every reading, alarm and intervention for the whole run, automates recirculation and additions end to end as repeatable ISA-88 recipes for walk-away operation, with alerts when the team is needed, and keeps control running locally for up to seven days without a cloud connection.

Related: Single-use bags · Organ perfusion fluid systems

Published research: Partridge EA et al. An extra-uterine system to physiologically support the extreme premature lamb. Nature Communications, 2017. doi:10.1038/ncomms15112

Get Started

Building an artificial womb
or ex utero program?

Tell us what you are building: the model, the volumes, the flows and how long it has to run. We will help design its fluid path.

Speak to an engineer

For research and development programs. We work with partners on the regulatory pathway for clinical applications.

Ready to talk?

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