Filtration & Separation Solutions

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Monoclonal Antibody Purification

Cell culture in the production of monoclonal antibodies commonly involves high-density cultivation of suspension cells. The cell culture supernatant obtained by culturing contains contaminants such as proteases, host cells, and cell fragments. These impurities can impact the stability and purity of the antibody. To ensure its suitability for subsequent antibody isolation and purification, the cell culture supernatant needs clarification through removal impurities.

 

Membrane filtration technology is an indispensable component of the antibody drug production process. It finds wide application in sterilizing culture media and buffers, rapidly separating cells and supernatant post-culture, and filtering gases during the fermentation process.

• Clarification (Deep Filtration): Removing cells and fragments

• Affinity Chromatography Capture: Isolating antibodies from cultured harvest

• Low pH Incubation: Virus inactivation

• Purification 1 (e.g., Anion Exchange): Removing impurities (DNA, HCP, viruses, endotoxins, etc.)

• Purification 2 (e.g., Cation Exchange): Removing impurities (aggregates, charge isoforms, etc.)

• Virus Removal Filtration: Virus clearance

• Ultrafiltration Permeation: Concentration and buffer exchange

 

To ensure an uninterrupted production process unaffected by external environmental factors, vent filter should be added to mixing and fermenting tanks. PTFE filter cartridges, with single-layer membranes, are suitable for this process.

 

In the pre-filtration stage for particle removal, larger pore size filter cartridges can be chosen to primarily remove large particles, protecting downstream smaller pore size filters. For removing small particle impurities and reducing microbial load, PES filter cartridges can be used, as they offer good filtration performance and ensure throughput and lifespan in terminal sterilization filtration.

 

Redundant and terminal sterilization filters should use the same type and precision of filter cartridges, typically employing double-layer PES pleated filter cartridges with a 0.22μm. While this choice provides guaranteed double-layer sterilization, it can affect throughput under conditions of high drug concentration or low filtration temperature. To ensure efficient terminal filtration, Multiple-stage filtration is recommended. It significantly enhances terminal sterilization efficiency, prolongs lifespan, and helps maintain cost control.

 

Feature-Tec Solution:

At Feature-Tec, we offer comprehensive pharmaceutical filtration solutions. Our experienced filtration experts will thoroughly understand your process requirements and recommend the appropriate filtration systems. From deep pre-filtration to terminal sterilization filters, Feature-Tec products are widely used in clarification, sterilization, and vent filtration processes, ensuring a more economically reliable pharmaceutical production process.

 

Benefits include:

• Effective reduction of bioburden

• Increased product yield

• Long service life

• Effective protection of downstream sterilization

• Filters chemically compatible with pharmaceutical liquids

 

 

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