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.

Clinical production · 10 – 15 L

BioPure 15L

Name: BioPure 15L
Brand: BioPure Certified

Clinical batches without re-engineering.

Phase I/II clinical supply with full automation, 21 CFR Part 11 compliance, and validated linear scale-up from the 3L. Built for the moment your therapy meets a patient.

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10–15 L working vol8–60 RPMIQ/OQ includedWireless remote control

BioPure 15L bioreactor — product photograph

● 15L · product photograph

15L · clinical

Working volume10 – 15 L

Mixing range8 – 60 RPM

Footprint120 × 140 cm

SensorsMulti-parameter PAT array

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 clinical production stage.

PVDF single-use vessel for clinical and early commercial production

Adjustable-height harvest valve for rapid harvest and medium exchange

Stainless steel housing with safety interlocks and spill catch

Wireless process control and remote alarm reporting

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

8 – 60 RPM

Brushless magnetic drive

Temperature

Ambient + 5 °C to 45 °C

Pt-100 dual RTD

Dissolved O₂

0 – 100% air sat.

Reusable optical

5.5 – 8.5

Reusable amperometric

Biomass

0 – 100 × 10⁶ cells/mL

Capacitance probe

Pressure / level

0 – 0.5 barG · 0 – 15 L

Load cell + diaphragm

Anatomy

Every part. Engineered for living cells.

Scroll to explode the vessel

Exploded view active · 15L

Specifications

Engineered for the room you'll put it in.

Vessel format

Single-use, cGMP-grade film

Working volume

10 – 15 L

Mixing range

8 – 60 RPM

Sensors

Multi-parameter PAT array

Footprint

120 × 140 cm

Compliance

IQ / OQ packages included

Head to head

BioPure 15L vs. incubation-based mini bioreactors.

Feature comparison between BioPure 15L and incubation-based mini bioreactors.
Capability	BioPure 15L	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.

Phase I / II supply

Investigator initiated trials

Compassionate use

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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