I.Overview
Ultrafiltration (UF) assumes the core tasks of concentration, purification, buffer replacement and removal of impurities in the separation of biological products, and is especially suitable for the fine treatment of large molecules of biologically active substances (e.g. proteins, vaccines, nucleic acids). UF system is the gold standard of biologics separation, and its irreplaceable core value in biopharmaceuticals lies in: activity preservation, precise separation, and compliance guarantee.
II.Key technology flow
Typical route for downstream purification of monoclonal antibody:
cell culture solution → centrifugation/microfiltration → Protein A chromatography → virus inactivation → **UF/DF (ultrafiltration dialysis)** → purified chromatography → preparation
Plasmid DNA purification process:
bacteriophage lysis → alkaline extraction → ultrafiltration (100 kDa) → affinity chromatography → **tangential flow ultrafiltration (TFF)** → sterile filtration
III.Core Performance Parameters
Parameter | Standard Requirement | ||||
Molecular Weight Cut - off | 1/3 - 1/6 of the target molecular weight (e.g., 30 kDa for monoclonal antibodies) | ||||
Recovery Rate | > 95% (for monoclonal antibodies) | ||||
HCP Residue | < 100 ppm | ||||
Endotoxin Removal | < 0.001 EU/mg | ||||
Shear Force Control | Laminar shear force < 10 Pa·s |
IV.Key Points for Equipment Selection
Membrane Module Type | Applicable Scenarios | |||
Hollow Fiber | Large - volume Processing (>500L) | |||
Flat Sheet Membrane Pack | High - value - added Products (e.g., Gene Therapy) | |||
Ceramic Membrane | High - Viscosity/Particulate - containing Feed Liquid |
V.Core Application Scenarios
Monoclonal Antibodies
Recombinant Proteins
Viral Vectors
Nucleic Acid Drugs
Vaccines
VI.Here is a guideline for you to get a proper quotation
Tell us the raw water/source of water(tap water, well water, or sea water, etc)
Provide water analysis report(TDS , conductivity, or resistivity, etc)
Required production capacity( 5m³/H, 50m³/H,or 500m³/H, etc)
What's the pure water used for( industrial,Food and Beverage,or agriculture, etc )