Integrity icellis. Single-Use Bioreactor for Process Intensification. The Source of Bioprocess Efficiency

Transcription

1 Integrity icellis Single-Use for Process Intensification ATMI LifeSciences The Source of Bioprocess Efficiency

2 Flexible, Fast, Effective Overview The icellis system, the world s first fully-integrated, high-cell density bioreactor, is designed to simplify your process by combining the advantages of single-use technologies with the benefits of a fixed-bed system. The compact system designed for quick implementation and ease-of-use represents a new generation of single-use bioreactors. Central to the icellis bioreactor technology is the use of a compact fixed-bed with pre-packed custom macrocarriers. This matrix contains medical-grade polyester microfibers and provides a large growth surface area in a compact bioreactor volume. Compared to a standard stirred-tank bioreactor using microcarriers, the icellis system avoids several delicate and time-consuming procedures, including manual operations, sterilization and hydration of microcarriers and bead-to-bead transfers from preculture to final process. With the biomass multiplication occurring in the fixed-bed, icellis bioreactors can be inoculated at very low density. The number and volumes of pre-culture steps are reduced considerably; two CF40 (.5 m ) or six Roller Bottles (750 cm ) are sufficient to inoculate an icellis 000 bioreactor. As a result of this process simplification, manual operations and associated costs are reduced dramatically. The icellis 000 device and skid. Evenly-distributed media circulation is achieved by a built-in magnetic drive impeller, ensuring low shear stress and high cell viability. The cell culture medium flows through the fixed-bed from the bottom to the top. At the top, the medium falls as a thin film down the outer wall where it takes up O to maintain high K L a the in the bioreactor. This unique waterfall oxygenation, together with a gentle agitation and biomass immobilization, enables the compact icellis system to achieve and maintain high cell densities, equaling the productivity of much larger stirred-tank units. Process simplification, from vial thawing to final product, is at the heart of the icellis platform. As cells are immobilized in the fixed-bed and the icellis system operates in perfusion mode, there is no need for centrifugation to harvest the cells, which further simplifies the downstream process. Microscopy view of MDCK cells immobilized on icellis carriers. Platform Highlights and Benefits oxygenation device, disposable probes that have been pre-installed and calibrated) volumetric productivity vs. traditional stirred tanks Media flow and average media in the icellis 000 (50-60L).

3 Efficient Solutions icellis s: Features and Configurations The icellis bioreactor is available in the following scales and configurations: Fixed-Bed Height (mm) Fixed Bed Surface Area (m) Compaction Compaction * (fully disposable) icellis icellis * Available in Q4, 0 icellis 000 Components Outer shell, top section with probes and ports: Media IN/OUT (), NaOH (3), Biomass probes (4), Gas IN/OUT (5), DO,pH & T probes (6), sampling (7) 8-0 Fixed-bed filled with macrocarriers (9), including a support part (0) and a retaining ring (8) - 3 Integrated mixing system magnetic impeller () inside a pump housing ( )and activated by a pump hosing ring (3) 4-5 Outer shell, bottom section

4 Process Efficiency From Process Control Systems Startup Requirements icellis 00 icellis 000 Power Requirement 500W 3500W 3500W () Power Supply Gas Requirements O CO bar bar Cross-section view of icellis 00. N Air bar System Specifications icellis 00 icellis 000 Dimensions (mm) 00 x 0 x x 50 x 650 Fully-integrated device Controller 60 x 300 x 0 60 x 300 x x 800 x 890 Weight Controller.5 kg 3.5 kg 0 kg 8 kg 300 kg Advance for feasibility studies and small-scale cell, protein and virus production. Instrumentation ph probes (single-use) * * Temperature probes Biomass probes (single-use) ** (option) (option) Pumps Control System for NaOH addition Perfusion module (option) NaOH addition, accessories NaOH Architecture PC-HMI PLC-HMI Compliance compliant (option) (0) compliant (option) compliant (back) and icellis 000 in operating mode. * Classic Probes available in single-use format ** Available on fully-disposable only

5 Single-Use Technology System s icellis 00 icellis 000 ph 6-8 ph units 6-8 ph units addition, addition DO 0-00% O addition Analog PI regulation 0-00% additions General overview from icellis 000 software. Temperature 5 to 40 C 30 to 40 C Peltier effect PI regulation Heating blanket regulation Speed 0-500rpm 0-400rpm Mixing System Magnetic drive impeller (integrated) Magnetic drive impeller (integrated) Perfusion Gas flow rates Perfusion system integrated (self-regulated pumping outflow - automatic and manual modes) Perfusion system integrated (self-regulated pumping outflow - automatic and manual modes) overview from icellis 000 software. O CO N Air Production Sequences Mode Available Data Recording/ Trending Available on external laptop (option) Available on external laptop (option) stored locally, SQL database (option) Alarm Management System Available Available Trend screen from icellis 000 software. * Except on the format - external device

6 Performance To demonstrate that the fixed-bed design of the icellis bioreactor achieves and maintains high-cell densities, cultures were performed with several cell lines. The following table highlights a summary of cell densities achieved in an icellis bioreactor at different scales and the com- requires limited adaptation protocols and enables easy scale-up for the majority of mammalian cell lines. icellis Validation Study Cell Line Bioproduct Achieved (*0 6 Equivalent for L icellis Reduction vs. Stirred Tank CHO Serum-Free MAb 00 to to 80x CEF Serum-Free MDBK lytic infection) 30 to CF0, 90 RB 80 CF0, 600 RB 0x VERO Serum-Free Influenza 8 75 CF0, 550 RB 30x VERO 75 to 50 (max) to 8x VERO Serum-Free 75 to 50 (max) 0x (feasibility) ATMI LifeSciences The Source of Bioprocess Efficiency Brochure BD007E 05rev ATMI, Rue de Ransbeek 30, 0 Brussels, Belgium, ATMI, 085 Louisiana Avenue South, Bloomington, MN USA, or info@atmi-lifesciences.com 0 ATMI, Inc. All rights reserved. ATMI, the ATMI logo, Integrity and icellis are trademarks or registered trademarks of Advanced Technology Materials, Inc. in the U.S., other countries, or both.