Filtration & Separation Solutions
Embrace Ultimate Application Challenges of Filtration, Separation, and Purification Technology
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:
Feature-Tec is a global leader in advanced filtration solutions for the biopharmaceutical industry. Specializing in monoclonal antibody (mAb) production, vaccine purification, ADC drug processing, and fermentation purification, we provide cutting-edge technologies including depth filtration, filter integrity testing, sterile filtration, and sterilizing gas filtration. Our comprehensive services also include filter validation, bacterial challenge testing, and chemical compatibility testing, ensuring the highest quality standards.
Feature-Tec’s filtration and separation technologies empower clients to enhance compliance in testing and validation. we support critical stages in drug and vaccine production, including clarification and bioburden reduction. By adhering to stringent global standards such as GMP, USP, ICH, ISO 17025, EMA Annex 1 (EU GMP), and PIC/S, We help our clients meet the highest standards of quality, safety, and regulatory compliance with our solutions.
Benefits include:
• Effective reduction of bioburden
• Increased product yield
• Long service life
• Effective protection of downstream sterilization
• Filters chemically compatible with pharmaceutical liquids
For partnership inquiries or more information, please email us at marketing@feature-tec.com
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Hotline: (+86)400-820-6150
Email: marketing@feature-tec.com
Address: 8/F, Block A, Building 3, Tianhua Information Technology Park, 299 Longcao Road, Xuhui District, Shanghai
