Column-Less Purification System | Noritake Co., Limited

01Core Technology

Downstream Innovation

A New Direction in Bioprocess Purification

The pharmaceutical industry is moving toward continuous processing and leaner manufacturing. In biopharmaceutical production, high consumable costs for column chromatography, combined with the significant labor required for centrifugation and clarification, remain a major bottleneck.
Drawing on decades of fluid-control expertise, Noritake has developed a breakthrough approach that purifies directly from cell culture fluid without relying on a packed-bed chromatography column.

Column Chromatography

Conventional column chromatography

Purification on a column packed with beads

Column-Less Technology

Noritake Column-Less Technology

Purification with the beads kept in flow

How Column-Less works

Example: affinity purification

Continuous purification with flowing bead slurry

What Column-Less purification delivers

No bead packing required

Simplified clarification

Reduced processing time and manual labor

Static Mixer

A mixing device with no moving parts that continuously mixes the fluid using fixed elements inside the pipe.

Cyclone Separator

A solid–liquid separation device with no moving parts that continuously separates solids from liquid by centrifugal force.

Continuous purification process

1. Capturing

Cell culture fluid and a Protein A bead slurry are combined in the static mixer so that the antibody adsorbs onto the beads. Impurities are then removed by the cyclone separator.

2. Cleaning

Wash buffer releases impurities bound to the Protein A beads, which are then removed by the cyclone separator.

3. Elution

Elution buffer is mixed in to release the antibody from the beads. The cyclone separator then separates beads from liquid, and the antibody-containing liquid is recovered.

4. Resin regeneration

After the purification cycle, the Protein A beads pass to regeneration and are reused once regenerated.

02Benefits

Column-Less Technology for higher
productivity and lower cost

Simplifying clarification and running purification continuously in a single system reduces equipment, consumables and processing time alike.

Example: antibody purification process

Conventional purification process

Bioreactor

Harvest tank

Centrifuge

Depth filter

Hold tank

Chromatography
(Capturing)

Viral
inactivation

UF/DF

Chromatography
(Polishing)

Conventional purification process: bioreactor, harvest tank, centrifuge, depth filter, hold tank, chromatography (capturing), viral inactivation, UF/DF and chromatography (polishing)

Requires connecting, switching, piping and operating multiple units

Column-Less purification process

Bioreactor

Viral
inactivation

UF/DF

Chromatography
(Polishing)

Column-Less Purification System

Covering clarification through initial purification in a single system

Process economics with Column-Less

Capital cost

−50%

vs. conventional process configuration

Bead consumption

−50%

vs. column chromatography

Footprint

−70%

vs. conventional process configuration

* Theoretical values assuming a 500 L culture scale and an antibody titer of 3 g/L. Actual results vary with the modality, process conditions and equipment configuration.

03Product Lineup

From lab to production,
systems matched to every scale

We offer systems suited to each stage of evaluation and throughput requirement, from lab-scale feasibility and pilot verification to full-scale production.

〜10 L

Lab scale / feasibility

Desktop Series

50–500 L

Pilot verification

Pilot Series

2,000–3,000 L

Production process design

Optimal configuration

LAB SCALEDesktop Series

A desktop system for screening adsorption, wash and elution conditions with small samples, and for evaluating recovery and quality.

Bioreactor scale

〜10L

System flow rate

40mL/min

Total processing time

〜5h (for 10 L)

Application: Screening and condition development / pre-adoption testing with small samples

Dimensions: H750 × W400 × D530 mm

Availability: Sample evaluation / rental / purchase

PILOT SCALEPilot Series

A pilot system that verifies process reproducibility based on the conditions established at lab scale.

Bioreactor scale

50〜500L

System flow rate

1L/min

Total processing time

〜8.5h (for 500 L)

Application: Scale-up verification and clinical supply manufacturing

Dimensions: H1,931 × W1,400 × D1,267 mm

Specification: Single-use compatible flow path

Availability: Purchase

04Case Studies

Feasibility studies with the
Column-Less Purification System

We are conducting feasibility studies across a wide range of purification targets, including enzymes and antibodies, using column-less continuous purification. These studies are conducted in collaboration with customers in Japan and overseas. Below are selected results that can be publicly disclosed.

Company A ×

Molecular-biology reagent manufacturer, North America

100% activity maintained in the purification of a His-tagged enzyme

TargetHis-tagged enzyme

Parameters evaluatedActivity retention

Purification methodImmobilized metal affinity chromatography (IMAC)

Customer challenge

Loss of activity after purification

A conventional IMAC column can generate high back pressure, and loss of activity in the His-tagged enzyme had been a persistent issue.

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Result

100% activity maintained

The effects of column back pressure are reduced, and 100% activity after purification was confirmed.

Activity after purification, conventional IMAC

50% or less

→

Activity after purification, column-less

100%

* The activity value for conventional IMAC was provided by Company A. The value for column-less purification was obtained in testing.

A new option: low-pressure purification

Because the Column-Less Purification System does not pack the beads into a column, adsorption, wash and elution take place at low pressure. This resolves the internal-pressure limitation that is difficult to overcome with conventional columns and maintains high activity. The result indicates that column-less purification can become a new option across a wide range of purification processes.

Other studies

Company B

Biopharmaceutical CDMO

Evaluation in progress

Evaluation is under way to explore the potential of this new purification technology

Further evaluations are in progress with several other companies.

Sample-based feasibility

Feasibility testing with your own sample

We accept testing requests using the Column-Less Purification System. Evaluation with your own sample on actual equipment is available.

Discuss a sample evaluation Evaluation process

05Evaluation Process

From first conversation to evaluation

You are welcome to contact us before the modality or purification conditions are fixed. Where the sample and evaluation criteria are already defined, we prepare a test plan covering analytical methods and acceptance criteria.

NDA / requirements

We define the modality, the current process, the quality targets and any constraints.

Evaluation plan

We set the sample quantity, the beads to be used, the analytical methods and the acceptance criteria.

Lab evaluation

We generate data on recovery, quality and the separation efficiency of the Cyclone Separator.

Review

We compare the results against the conventional method and define the applicable range and the next issues to address.

Next stage

We consider scale-up, continuous operation and the move to a full equipment configuration.

Discuss an evaluation

Enquiries about the Column-Less Purification System

For a detailed briefing, a demonstration or loan of test equipment, please get in touch.

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Feasibility testing / equipment loan Product or technical question Request a quotation Other enquiry

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Column-free.Low-pressure.Continuous.