What utilities does the system need?

100–240V single-phase power, clean dry air, CO₂ and O₂ gas lines. Detailed utility tables ship with the IQ/OQ package.

How long is vessel lead time?

Standard single-use vessels ship in 4–6 weeks. Validated customer configurations are stocked under VMI agreements.

Does the process transfer to larger scales?

Yes — every BioPure Vertical Wheel shares the same hydrodynamic profile. Process locks transfer linearly through the 80L commercial system.

What training is included?

Two days of on-site engineering training, recorded SOPs, and 12 months of priority application support are included with every system.

Can I integrate it with my MES / historian?

BioLogic™ exposes OPC-UA tags and CSV/PDF export; REST hooks are available for cloud historians.

Commercial scale · 50 – 80 L

BioPure 80L

Name: BioPure 80L
Brand: BioPure Certified

Commercial cell therapy, finally manufacturable.

The 80L Vertical Wheel is the largest single-use cell therapy bioreactor available — engineered for cGMP commercial manufacturing of approved CAR-T, MSC, and iPSC-derived therapies at population scale.

Request quote Talk to engineering

50–80 L working vol5–45 RPMRaman PAT12 batches / month

BioPure 80L bioreactor — product photograph

● 80L · product photograph

80L · commercial

Working volume50 – 80 L

Mixing range5 – 45 RPM

Footprint200 × 220 cm

SensorsFull PAT + Raman

2×

Higher cell yield

PSC growth with DO control vs. PBS-Mini 0.5L

Batches in parallel

Per cleanroom suite

60 mL → 80 L

Linear scale-up

Same Vertical Wheel geometry, every scale

Why this system

Built for the commercial scale stage.

Largest single-use cell therapy bioreactor available — 50 – 80 L working volume

Engineered for cGMP commercial allogeneic manufacturing

Full PAT array with Raman for real-time release-supporting data

Validated linear scale-up from 3L and 15L — no re-engineering

Why teams choose this platform

Five reasons it beats incubation-based minis.

Higher yield, lower cost

Precise DO control overcomes the gas-exchange limits of incubation-based culture — extending the growth phase and doubling viable cell yield per batch.

2× cell yield

Full automation at mini scale

Large-scale automation packaged for development: real-time pH, integrated gassing, recipe building, and remote monitoring from day one.

Recipe + remote

Closed-system operation

Closed sampling, supplementation, and perfusion-based medium exchange — sterility preserved, operator variability eliminated.

Closed sterile

Seamless path to scale

True scale-down model. The same Vertical Wheel hydrodynamics carry through 3L, 15L, and 80L GMP production with no re-engineering.

60 mL → 80 L

Purpose-built for cell therapy

Engineered for shear-sensitive cells: PSC aggregate homogeneity, MSC viability, CAR-T phenotype — preserved from PD through GMP.

Phenotype safe

Operating workflow

From unboxing to inoculation in five steps.

Step 01

Calibrate

Enter vessel calibration data and prime sensors.

Ch. 6 · p. 63

Step 02

Install vessel

Mount single-use vessel; level adjust to 0 mL.

Ch. 6 · p. 66

Step 03

Prime & fill

Load tubing, prime pumps, dispense medium.

Ch. 6 · p. 76

Step 04

Ramp & inoculate

Set alarms to ramp, equilibrate, inoculate.

Ch. 6 · p. 87

Step 05

Sample / harvest

Sterile sampling, perfusion or harvest line.

Ch. 6 · p. 95

Control envelope

Every parameter you'll close-loop on day one.

Parameter

Operating range

Sensor

Agitation

5 – 45 RPM

Brushless magnetic drive

Temperature

Ambient + 5 °C to 42 °C

Pt-100 dual RTD

Dissolved O₂

0 – 100% air sat.

Reusable optical (dual)

5.5 – 8.5

Reusable amperometric (dual)

Biomass

0 – 200 × 10⁶ cells/mL

Capacitance probe

Raman

Full metabolite panel

Inline Raman flow cell

Anatomy

Every part. Engineered for living cells.

Scroll to explode the vessel

Exploded view active · 80L

Specifications

Engineered for the room you'll put it in.

Vessel format

Single-use, cGMP-grade film

Working volume

50 – 80 L

Mixing range

5 – 45 RPM

Sensors

Full PAT + Raman

Footprint

200 × 220 cm

Throughput

Up to 12 batches / month

Head to head

BioPure 80L vs. incubation-based mini bioreactors.

Feature comparison between BioPure 80L and incubation-based mini bioreactors.
Capability	BioPure 80L	Incubation-based minis
Real-time DO control	Closed-loop split-range	Not supported
Inline pH monitoring	Compendial-aligned	Offline only
Closed sampling & perfusion	Integrated	Not supported
Parallel cultures from one controller	Up to 24 vessels	Manual setup
Scale-down fidelity to GMP	Identical Vertical Wheel hydrodynamics	Geometry change required
Recipe automation & remote monitoring	Built-in	Not supported

Compliance & regulatory

Audit-ready out of the crate.

USP Class VI / ISO 10993 contact materials

Gamma-irradiated single-use vessel (SAL 10⁻⁶)

BioLogic™ software — 21 CFR Part 11 audit trails

IQ / OQ documentation packages available

Clinical applications

Validated for the modalities you're building.

Commercial CAR-T

MSC manufacturing

iPSC-derived therapies

The cost of the old way

Every day a cell therapy batch is delayed,
a patient's window closes.

Per day in COGS, per delayed batch

Of cell therapy programs fail at scale-up

0 mo

Average delay to re-engineer a stirred-tank process

Industry averages compiled from BioProcess International, Alliance for Regenerative Medicine, and PBS Biotech case studies. The Vertical-Wheel® is engineered so a process locked at PBS-3 transfers to PBS-80 without re-validation.

ROI Calculator