Cellab® Bioreactor System

Parallelization of the hollow fiber infection model for your PK/PD studies

The In-vitro Hollow fiber Model has already provided proven results for the preclinical development of anti-tuberculosis drugs and represents a qualified system model by the EMA (see CHMP Qualification Opinion [1]). It offers predictive accuracy higher than 90 % and offers significant advantages to animal models or static assays [2].

chmp

Application

  • Preclinical PK/PD during the development of antimicrobial medicinal products for infectious disease
  • Efficacy optimization of dosing regimens and drug combination therapies e.g. in tuberculosis
  • Simulation of the in-vivo activity and resistance of antibiotics
  • Replacement of animal studies during preclinical drug development

Why in-vitro hollow fiber model systems improve your PK/PD analysis

  • PK/PD indices are determined based on larger pool of infected organisms
  • A wider dosing range of the drug inocula as it is possible and justifiable in animal models
  • Continuous and reliable measurement of the AUC/MIC, Peak/MIC, half-lives and time-kill curves
  • Precisely monitoring of the absorption and elimination kinetics
  • Prevent bacterial elimination using semipermeable membranes

Benefits for your PK/PD studies working with the Cellab® DisposableSet with 5 small hollow fiber modules in parallel

The Cellab® Bioreactor System consists of a disposable set equipped with different single use bioreactor configurations including hollow fiber membrane modules and a reusable docking station containing all components to operate the disposable set and to communicate with the control computer. The Disposable Sets are delivered fully assembled and presterilized including up to 5 hollow fiber modules with 5 individual central media reservoirs plus additional sample ports, tubing and connectors. The whole system is designed to be operated in a standard CO2-incubator.

  • Quick equilibration of the antibiotic level in the ECS and ICS
  • Reduce the risk of contamination in closed semi-automated systems
  • Simultaneous evaluation of multiple dosing regimens in up to 5 HF-models in parallel
 ecs

Discover more about the Cellab® Bioreactor System and its different product solutions on our website or contact us directly. We will be happy to provide you all the info you need.

Ordering Information

Article numberCellab SystemMembraneECS-Surface AreaECS-VolumeMedium Reservoir
0510058 Disposable Set 5 HF/S (ECS) Polysulfone (20 kDa) 190 cm² 1.6 ml 5 x 100 ml
0510017 Docking Station DS-04        

Are you interested in Cellab hollow fiber system for PK/PD? Would you require an adaptation of the system to suit your needs?
Please contact us, we are looking for partners to develop the optimal hollow fiber infection model system for PK/PD studies.

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[1] In-vitro Hollow Fiber System model of tuberculosis (HSF-TB)
EMA/CHMP/SAWP/47290/2015 Corr.
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/02/WC500181899.pdf

[2] - Gumbo et. al.: Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes; Clinical Infectious Diseases® 2015;61(S1):S25–31
https://pdfs.semanticscholar.org/27a0/e28825919b55e51660f4c119e2555f86cdc5.pdf