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.

Bench-scale production · 1.8 – 3 L

BioPure 3L

Name: BioPure 3L
Brand: BioPure Certified

Bench-scale that behaves like commercial.

The 3L is the inflection point: identical hydrodynamics to the 80L commercial system, packaged for bench operation. Validate your process once and trust it at every subsequent scale.

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1.8–3 L working vol10–80 RPM21 CFR Part 11PAT array + glucose

BioPure 3L bioreactor — product photograph

● 3L · product photograph

3L · bench

Working volume1.8 – 3 L

Mixing range10 – 80 RPM

Footprint60 × 70 cm

SensorspH, DO, temp, biomass, glucose

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 bench-scale production stage.

1.8 – 3L working volume — true bench-scale stem cell production

Integrated touchscreen control with autopilot pump feedback

21 CFR Part 11 audit-trail compliant software

Sterile access ports for sampling, harvesting, and reusable sensors

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

10 – 80 RPM

Magnetic drive encoder

Temperature

Ambient + 5 °C to 45 °C

Pt-100 RTD

Dissolved O₂

0 – 100% air sat.

Reusable optical / patch

5.5 – 8.5

Reusable / single-use optical

Biomass

0 – 60 × 10⁶ cells/mL

Capacitance probe

Glucose / lactate

0 – 10 g/L

Inline metabolite probe

Anatomy

Every part. Engineered for living cells.

Scroll to explode the vessel

Exploded view active · 3L

Specifications

Engineered for the room you'll put it in.

Vessel format

Single-use, cGMP-grade film

Working volume

1.8 – 3 L

Mixing range

10 – 80 RPM

Sensors

pH, DO, temp, biomass, glucose

Footprint

60 × 70 cm

Software

BioLogic™ 21 CFR Part 11

Head to head

BioPure 3L vs. incubation-based mini bioreactors.

Feature comparison between BioPure 3L and incubation-based mini bioreactors.
Capability	BioPure 3L	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.

Pre-clinical material

Process lock

Tox & potency batches

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.

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