Nanometer-scale downstream virus control

Virus Filtration

Scalable virus-removal and prefiltration options for downstream bioprocessing.

A nominal 15–50 nm rating alone does not establish a validated virus-removal claim

Virus filtration and prefiltration product family
Scalable virus-filtration and prefilter portfolio Syringe · Pilot cassette · Production cassette
15–50 nm Nominal virus-filter range
3 purposes Virus removal and two prefilter families
3 scales Syringe, pilot and production
2.5 cm²–1.8 m² Portfolio filtration area

Progress from low-volume feasibility studies to qualified manufacturing-scale filtration.

The portfolio combines nanometer-scale virus-removal membranes with nylon and depth-prefilter options. Scalable formats support membrane screening, filterability evaluation, process sizing, validation studies and larger downstream batches.

Format 01 · Syringe

Low-volume screening and feasibility evaluation

Small-area syringe devices reduce sample consumption during early membrane screening, filterability checks and product-recovery assessment.

  • Virus-removal and prefilter formats
  • Areas from 2.5 to 4.5 cm²
  • Representative-feed feasibility work

Best fit Screening and feasibility

Format 02 · Pilot cassette

Process development, sizing and validation support

Multiple pilot-scale membrane areas support optimization, scale-down modeling, prefilter-ratio studies and preparation for virus-clearance validation.

  • Virus-removal and prefilter cassette families
  • Multiple areas for scalable development
  • Operating-window and recovery studies

Best fit Development and validation

Format 03 · Production cassette

Scalable filtration for larger downstream batches

Production-scale cassettes support virus removal and prefiltration after filterability, compatibility, scaling and validation work has established the qualified process design space.

  • Areas up to 1.8 m² across the portfolio
  • Dedicated virus-removal and prefilter families
  • Manufacturing-scale filtration trains

Best fit Pilot and manufacturing batches

Virus-removal and prefilter train selection

Protect the virus-retentive membrane with a representative, experimentally sized prefilter train.

PES, regenerated-cellulose and multilayer virus-filtration media are available alongside nylon and cellulose-based depth prefilters. Dedicated prefilters can reduce aggregates, colloids and other fouling species before the virus-retentive membrane.

15–50 nm Nominal virus-removal membrane range
Experimental ratio Set prefilter-to-virus-filter area with actual feed
01 Virus removal Nanometer-scale PES, regenerated-cellulose or multilayer membranes for validated size-exclusion-based virus retention Final retentive step
02 Nylon prefilter Hydrophilic membrane used to reduce selected particulates and membrane-fouling species Membrane protection
03 Depth prefilter Cellulose, diatomaceous-earth and nylon matrix for mechanical and adsorptive reduction of aggregates, colloids and foulants Higher foulant load

Downstream virus-clearance steps and prefilter protection for biological products.

Virus-filter performance is highly dependent on feed composition, protein concentration, aggregate level, viscosity, pressure, temperature and processing time. Representative filterability and recovery studies should precede scale-up.

01

Monoclonal antibodies and proteins

Virus-removal filtration in downstream purification of compatible antibody and recombinant-protein streams.

02

Plasma-derived and biological products

Virus-clearance steps for selected compatible plasma-derived and biological-product process streams.

03

Post-chromatography polishing

Virus filtration within post-chromatography and final downstream polishing sequences.

04

Process development and scale-down

Filterability evaluation, sizing and representative small-scale virus-clearance model development.

05

Aggregate and colloid reduction

Nylon or depth prefiltration to manage foulants before the virus-retentive membrane.

06

Vaccines, enzymes and other biologics

Development and scale-up of compatible downstream filtration trains for additional biological products.

Begin with representative-feed studies and scale within the qualified operating design space.

Confirm the prefilter-to-virus-filter area ratio experimentally. Virus-clearance validation should use a representative scale-down model, relevant model viruses, defined operating limits and a correlated integrity-test strategy.

01

Clearance objective and challenge model

Define the virus-clearance objective, regulatory strategy, target and model viruses, morphology and challenge design.

02

Feed composition and product interaction

Provide protein concentration, viscosity, product-interaction risk and required recovery.

03

Aggregate and foulant burden

Characterize aggregate, colloid and particulate loading and the need for nylon or depth prefiltration.

04

Throughput and operating limits

Confirm expected throughput, processing time, flux, differential pressure and temperature.

05

Scale-down and integrity strategy

Define the representative model, membrane-area scaling basis, and pre-use and post-use integrity-test criteria.

06

Recovery, flush and compatibility

Assess acceptable yield loss, flush volume, hold-up volume, extractables and material compatibility.

Configuration matrix

Review media families, scale formats and available filtration areas.

Virus-removal, nylon-prefilter and depth-prefilter configurations are distinct product families. Not every medium, area or format is interchangeable. Confirm product binding, recovery, extractables, chemical compatibility, flush requirements and downstream effects using the actual process fluid.

Media selection Format configuration

Media options

Media General characteristics Suggested applications
PES Hydrophilic polyethersulfone membrane offering high liquid flow and compatibility with many aqueous biological streams Small-scale virus-removal evaluation and compatible protein or biological-product solutions
Regenerated cellulose Hydrophilic membrane selected where low nonspecific interaction and product recovery are important Pilot-scale virus-removal studies and compatible protein-containing process fluids
Nylon Hydrophilic membrane used as a prefilter to reduce selected particulates and membrane-fouling species Prefiltration before virus-removal membranes
Cellulose / diatomaceous earth / nylon Depth-prefilter matrix combining mechanical capture through the media thickness with adsorptive retention Aggregate, colloid and foulant reduction before virus filtration

Product configurations

Purpose Format Media Pore Size Filtration area
Virus Removal Syringe filter PES 15~50 nm 2.5 cm²
Cassette-Pilot scale RC 0.015 / 0.08 / 0.3 / 0.5 m²
Cassette-Production scale Multilayer virus-filtration membrane 1.50 m²
Nylon Prefilter Syringe filter Nylon 3.4 cm²
Cassette-Pilot scale 0.025 / 0.12 / 0.3 m²
Cassette-Production scale 0.60 / 1.20 / 1.80 m²
Depth Prefilter Syringe filter Cellulose, Diatomite, Nylon 4.5 cm²
Cassette-Pilot scale 0.027 / 0.15 / 0.4 m²
Cassette-Production scale 0.92 / 1.1 m² 0.11 / 0.55 / 1.1 m²

Prepare the right virus-filtration train for your customer project.

Confirm the clearance objective, representative feed, model-virus strategy, virus-removal medium, prefilter need, area ratio, throughput, pressure, recovery, scale-down model and integrity-test approach before submitting the final RFQ for technical review.