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XperCell™ ATF Hollow Fiber Filter for Perfusion Cell Culture Process, 1/pk

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Part No. HFEF2M20R1060AP
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*Not for medical use

Cobetter XperCell™ ATF hollow fiber product is specially developed for perfusion cell culture process. The main body of the series is made of Cobetter's self-produced polyethersulfone (PES) hollow fiber membrane filament. The raw material has been tested and validated to have the features of low E&L profile and good biocompatibility. Cobetter ATF hollow fiber product is suitable for cell culture processes such as medium exchanging, continuous cell clarifying and harvesting from 1L to 2000L culture scale, which meets the requirements from R&D to commercialization. 

It is manufactured following strict quality control standards. The production process is carried out in accordance with the ISO9001-2015 quality management system, and is all done under ISO Class 7. Each hollow fiber products will passed the integrity test and water flux test before release. Quality documentation can be provided to help bio-pharmaceutical customers' safety production and audit requirements.

Features

  • 100% product integrity test;
  • Low bioburden, no cytotoxicity;
  • ADCF, good biocompatibility;
  • Portable, flexible connection to 1L-2000L single-use bioreactors
  • Single-use format available. Gamma irradiated and ready to use. Eliminating the need for complex on-site assembly and sterilization operations, improving manufacturing efficiency;
  • All series of hollow fiber membrane columns can withstand regular autoclaving sterilization procedures, reducing the investment of high-cost sterilization equipment;
  • Breakthrough the limitation of cell density in batch/ fedBatch process while maintaining high cell viability.

Applications

Pefusion cell culture process, including:

  • N-1 high cell density seed culturing
  • Medium exchanging and target product harvesting in dynamic/continuous perfusion cell culturing
  • Medium exchanging in concentrated fed-batch cell culturing
  • Cell lysis clarification and concentration

Multiple fields of cell/microbial culture including:

  • Bio-pharmaceuticals such as antibody, vaccine and CGT
  • Food industries such as culture meat and wine-making

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available
Physical Properties Filter Format XperCell™ ATF Hollow Fiber
Scale Large-scale Process Development
Commercial Manufacturing
Bioreactor Working Volume ATF 2: 1-10 L
ATF 6: 50-200 L
ATF 10: 200-1000 L
Filter Length 60 cm
MWCO 50 kDa, 0.2 μm
Recommended Flow Rate (perfusion) 5-15 mL/min/Fiber
or 3-8 L/min/m²
Applications Typical Application Pefusion cell culture process
Materials Membrane Material Polyethersulfone (PES)
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Non sterile
Pre-sterilized
Sterilization Method Non-sterile: Gamma compatible
Sterile: by gamma irradiation at 25–45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 

Operating Parameters

Models Bioreactor Working
Volume		 Number of
Fibers		 EFA Exchange Volume Flow Range
ATF 2 1 - 10 L 75 0.13 m² 0.1 L 0.3-1.5 LPM
ATF 6 50 - 200 L 1,440 2.5 m² 1.3 L 5-20 LPM
ATF 10 200 - 1000 L 6,720 11 m² 6 L 20-90 LPM

 
  • Cobetter_ATF_Hollow_Fiber_Ver01-b_202507 Download
What are the advantages of hollow fiber compared to cassette (flat-sheet) modules?

1. More open flow channels and relatively lower shear.
2. High packing density and large surface area per module enable a compact system footprint with minimal hold-up volume.
3. Robust handling of challenging feed streams, including high solids content or viscosity.
4. Suited for large-volume, high-flow continuous processing in drug manufacturing, such as for insulin and animal vaccines.

What are the applications of hollow fiber technology?
  • Concentration and buffer exchange of viral vaccines
  • Concentration and diafiltration of Cell and Gene Therapy (CGT) products
  • Purification, concentration, and buffer exchange of mRNA products
  • Biomass harvesting from bacterial fermentation, and clarification/removal of cell debris from cell culture lysates
  • Cell retention in perfusion culture (ATF system)