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KDBIO – Distributor for the FiberCell Systems hollow fiber bioreactor Logo KDBIO – Distributor for the FiberCell Systems hollow fiber bioreactor Logo KDBIO – Distributor for the FiberCell Systems hollow fiber bioreactor Logo
  • Hollow Fibre Culture
    • Hollow Fibre Culture
    • Media for Bioreactor
    • Cell types
    • Scale-Up
  • Applications
    • Monoclonal Antibodies
    • Recombinant Protein
    • Extracellular Vesicles / Exosomes
    • 3D Culture Secretome
    • Virus
    • Gut Model
    • Endothelial Cells w/Flow
    • In vitro PK/PD >
      • The Hollow Fibre Infection Model
      • Oncology
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    • Support for FiberCell® Products
Home>Support>Support for FiberCell Products
Support for FiberCell Productsadmin2021-02-04T08:35:12+00:00

Getting started with the FiberCell HF Bioreactor

•   VIDEO: Setting up a FiberCell Systems Hollow Fibre Bioreactor
•   FiberCell Systems Quick Start Guide

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Manuals

•   FiberCell Systems Duet Pump Operating Instructions
•   FiberCell Systems Quick Start Guide
•       Bioreactor monitoring chart (Excel)
•   FiberCell Systems CDM-HD Usage Instructions
•   FiberCell Systems Endothelial Cartridge Instructions
•   FiberCell Systems Sterile Sample Port
• FiberCell Systems User’s Manual (under revision)

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Customer Publications by Application

• Extracellular vesicles
• Monoclonal antibodies
• Recombinant mAbs, vaccines, cytokines & difficult to express proteins
• Cell secretome using 5 kD MWCO fibre
• Virus production
• Endothelial cells under shear stress in artificial capillaries
• In-vitro PK/PD (antimicrobial)

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Articles

•   Production of Exosomes in a Hollow Fiber Bioreactor (2017)
•   GEN Tutorial: Hollow Fibers Enhance Protein Expression
•   An HFBR Allows Any Lab to Efficiently Express Rec. Proteins in Mammalian Cells (2017)
•   Production of Monoclonal Antibodies from Hybridomas in an HF Bioreactor (2017)
•   3D Cell Culture in HF Bioreactors
•   Continuous Production of Exosomes (GEN, 2015)
•   Interest in Hollow Fiber Perfusion Bioreactors is Growing – (BioProcess International, 2009)

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Posters

• ISEV Poster – Amniotic stem cell EVs produced in a 3-D hollow fiber
• ISEV Poster – Clinical Scale Production and Wound Healing Activity of Human Adipose Derived MSC EV’s from a Hollow Fiber Bioreactor…
• ISEV 2016 Poster – Large Scale Production of EVs in a Hollow Fiber Bioreactor
•   FiberCell Systems Poster – Continuous Collection of Stem Cells from a Human Placenta Perfusion Co-Culture
•   ZenBio Poster – Scalable production of exosomes and their potential use as a therapeutic for tendinopathy

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Sales Brochures

• Hollow fibre infection model for antimicrobial PK/PD
• Fast and Efficient Production of Monoclonal Antibodies
• Produce Well-Folded and Glycosylated Recombinant Proteins
• Efficient Production of Extracellular Vesicles / Exosomes
• CDM-HD Chemically Defined Media for High Density Cultures
• FiberCell Systems Brochure

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Video manuals for new users

• VIDEO – Operating the FiberCell Systems Duet pump
• VIDEO – Setting up a FiberCell Systems bioreactor prior to inoculation of cells
• VIDEO – Inoculating cells into cartridge
• VIDEO – Preparing CDM-HD chemically defined serum replacement
• VIDEO – Standard harvesting procedure – “Low Glucose Rate”

• VIDEO – Reducing cell mass as required – “High Glucose Rate Harvest”
• FiberCell Systems YouTube Channel”

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Distributor for FiberCell Systems Inc. – easy scale-up of cell culture for secreted product harvesting, culture under flow conditions and systems for simulating drug PK/PD in vitro

Applications:

  • Monoclonal Antibodies
  • Recombinant Proteins
  • Exosomes
  • 3D Culture
  • Virus

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  • KDBIO S.A.S.
  • 6 R. IRIS, 67370, Berstett, France
  • Tel: +33 388 261 286
  • Fax: +33 970 061 387
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Text from EMA Qualification Opinion on In-vitro hollow fiber system model of tuberculosis (HSF-TB)
…
4.3 Proposed Use of HFS-TB in Drug Development
The HFS-TB can: (1) mimic the concentration-time profiles of antibiotics observed in TB patients, (2) mimic the metabolic and physiologic behavior of Mtb populations commonly encountered in infected patients with pulmonary TB and the intracellular Mtb characteristic of disseminated TB and (3) quantify the sensitivity and resistance of these Mtb populations to various doses and combinations of antibiotic agents over time. When these outcomes are correctly achieved, the results can then be used in Monte Carlo simulations to identify
(i) optimal doses of drugs,
(ii) drug combinations which are most likely to achieve desired microbial outcomes,
(iii) expected response rates from a drug or combination regimen,
(iv) expected rates of and time to resistance emergence in patients and
(v) susceptibility breakpoints based on a minimum inhibitory concentration (MIC) above which therapy by a specific drug will fail.

The HFS-TB is proposed for use in optimization of drug regimens and dose selection to maximize the bactericidal and sterilizing effect rates and minimize the emergence of resistance. When used early in the drug development cycle as a complementary and additional tool to existing methodologies, information regarding optimal dose selection, dosing schedules and potential combination therapies can be obtained. Additionally, the HFS-TB can be used in a post-approval setting to optimize currently used drug regimens (for both dose and dosing schedule) for drug-susceptible and drug-resistant TB. Therefore, the results obtained by the HFS-TB are expected to support trial design for Phase I, II, III and IV clinical trials.


“The HFS-TB tool has a validated predictive accuracy of 94% in forecasting optimal drug exposures, susceptibility breakpoints, rates and time to emergence of resistance and doses to be used in drug regimens to treat TB”
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