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3. Overview
The iCELLis 500 bioreactor platform is a high-cell density culture system designed for animal cell
culture under large scale Good Manufacturing Practices (GMP) production. It consists of a single-use
fixed-bed bioreactor and a docking station including controlling system with integrated measuring,
agitation, temperature control and pumping elements to operate the bioreactor.
3.1 iCELLis 500+ Single-Use Fixed-Bed Bioreactor
The iCELLis 500+ bioreactor is fully sinle-use including its sensors. The bioreactor vessel contains a
pre-packed fixed-bed made of Pall’s proprietary iPack carriers designed for both suspension and
adherent cells which grow entrapped in the fixed-bed. This matrix is made of medical grade
polyethylene teraphalate (PET). microfibers.
The volume of the fixed-bed (number of carriers) varies depending on the bioreactor model but the
outer shell (body) of the bioreactor does not change with the fixed-bed volume and offers a maximum
working volume of ~74 L (Further media volume can be added through perfusion/ recirculation). Hence,
the same docking and controlling station is used with all iCELLis 500+ bioreactors.
The volume in the bioreactor which the fixed-bed occupies varies from 5 to 25 L offering a cell
adherence equivalent surface area between 66 to 500 m² respectively. A surface area of 500 m² is
equivalent to ~3,000 roller bottles (1700 cm² each).
The main elements of the iCELLis 500+ bioreactor are:
•
A body made of Polyethylene Terephthalate Glycol (PETG) parts, including a double-jacket for
temperature control;
•
A fixed-bed made of PET carriers;
•
Different tubing and accessories such as integrated single use pH, DO, pressure and optional
Biomass sensors (Figure 1).
The bioreactor is manufactured and assembled in accordance with ISO 14644-1 Class 8 cleanroom
guidelines. Unless specifically marked otherwise, the bioreactor is delivered gamma-irradiated at a
minimum of 25 kGy (range of 25 to 50 kGy). The product label includes a gamma exposure indicator
(color change gamma-exposure indicator).
