Thermo Scientific HyClone Single-Use Bioreactor Products and Capabilities. Discovery Development Production

Transcription

1 Thermo Scientific HyClone Single-Use Bioreactor Products and Capabilities Discovery Development Production

2 Introduction Leading the way in Single-Use Bioreactors Since its introduction, the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) has become the leading disposable system from L for animal cell bioprocessing. Our unique approach combines well-characterized elements used in stainless steel systems with components that offer all the benefits found in single-use bioreactors. Our customers range from small biotech companies to major biopharm manufacturers, and their feedback forms the basis for ongoing development to meet your needs for tomorrow. Unique Hybrid Design, Comparable Bioprocessing Results The S.U.B. is based on a conventional stirred tank approach rather than less characterized designs. The S.U.B. BioProcess Container (BPC ) is a fully functional bioreactor vessel including single-use contact surfaces for mixing, venting, sparging and temperature sensing. Ports are provided for monitoring, sampling and liquid transfers. The unique mixing system (patent pending) provides overhead mixing while maintaining sterility and integrity. A re-usable outer support container also provides a mixer motor, heating/cooling, control unit for integration with an external control system and a mobile skid. Data from multiple customers using industry standard cell platforms have been published and presented at conferences demonstrating the equivalence of bioprocessing results to conventional stainless steel systems. Open Architecture, Standard Components Help Meet Budgets and Timelines The S.U.B. is sold without a control system for ph and dissolved oxygen, allowing economical and rapid replacement of the vessel in an existing bioreactor system. This also provides customers with a choice of control units for a new system implementation. The S.U.B. design utilizes standard hardware and BPC products to get you into production within a few months rather than a year or more for other systems. Single-Use Processing Advantages The S.U.B. offers the advantages of single-use processing: No cleaning or sterilization (apart from the monitoring probes) Reduced turnaround and setup times Minimal validation Reduced investment and running costs Increased flexibility of manufacturing capacity Reduced time-to-market for your product Our economic modeling system can provide you with an indication of potential benefits based on your specific variables. The S.U.B. product range provides working volumes from L, allowing seamless scale up. BioProcessing Expertise We are a manufacturer of both single-use and cell culture products, giving us unique capabilities to support bioprocessing systems. With extensive experience operating the S.U.B. in our development laboratories, we are able to offer real set-up and applications support to users. The operating advantages of the S.U.B. have helped make it the system of choice.

3 Winning Design Gets You to the Finish Line Faster The Single-Use Bioreactor (S.U.B.) combines elements of stirred tank systems with the efficiencies in turnaround, cleanup and validation found in single-use processing. Utilizing standard hardware, our proven BioProcess Containers and a choice of control options, the S.U.B. can get you into production in months instead of years. Product Design Safety Cover Mixer Motor Drive Shaft Vent Filter Drive Shaft (integrates with seal/bearing assembly) Gas Overlay Port Ports Seal/Bearing Assembly (integrated into the BPC film) Tubing Forming Shaft Sheath Ports with Kleenpak Connectors Impeller Temperture RTD Port Sampling Port Drain Port Gas Sparges

4 Flexible, Proven Technology Your Choice of Control Systems For customers with existing systems, our retrofit approach allows you to use your current control system with the S.U.B., simplifying and lowering the cost of implementation. We have established a plug-and-play capability based on common connectors. Most control suppliers have experience with S.U.B. integration and support is also available through our Technical Service team. In new operations we realize the importance of individual control preference and the need for integration support. Our open architecture approach enables you to select both the preferred control system for use with the S.U.B. and your preferred method of integration. You can source the control system and S.U.B. direct and project manage the integration. Alternatively, you can source a complete turnkey system based on the S.U.B. from a bioreactor integrator. The growing list of control partners with extensive experience in turnkey implementations of S.U.B. systems includes ABEC, Applikon Biotechnology, Broadley-James Corporation, Das-Gip and Finesse Solutions, LLC. For further information on control system and turnkey implementation options contact your sales representative. The S.U.B. allows you to choose your preferred control system. Proven Technology in the Lab and the Field Extensive comparative testing of the S.U.B. has been conducted using most of the common animal cell platforms, both in our development laboratories and within our installed base of over 250 units in the biopharm industry. These tests show equivalent cell growth and protein production to conventional stainless steel and rocker-style systems, and characterization of the resulting protein is also comparable to conventional systems. For interested clients, our industry specific presentations include positive customer results with batch fed and perfusion modes of operation. In addition to functional equivalence, reports are available that demonstrate the economic benefits of the S.U.B. in terms of reduced investment and running costs. To access this information, or our growing library of new reports, contact your sales representative. The S.U.B. is currently scalable to a 1000 L working volume.

5 Support You Can Rely On Each S.U.B. hardware unit is supplied with the following support documentation to provide validation and setup information: Comprehensive User's Guide Equipment Turnover Package drawing, specification, qualification and user information for the hardware Validation Guide validation information for the S.U.B. BPC In addition, we have extensive applications expertise and documentation with the S.U.B. accessible through our global sales and technical support teams. A member of our global team of Technical Service experts can work with you on-site to set up, qualify, operate and troubleshoot the system. They also provide access to extensive engineering and cell culture laboratory capabilities for in-house application and validation services. For peace of mind, and to protect your process, service for S.U.B. hardware units is available worldwide. Service level options during and after the warranty period range from preventive plans to a premium level with unlimited emergency visits. Advancing the Technology We have ongoing development programs to further advance, expand and enhance S.U.B. technology and the product range. Among current projects are: Scalability We continually evaluate the market need and technology for larger and smaller volume systems for research and process development to meet the needs of clients. Alternative Sparging Systems New, optimized S.U.B. BPCs are now available with dual sparge systems including both open pipe and micro porous frit designs. These provide a greater range of k L a values, better ph control and lower foaming than the original disk sparger. Single-use Non-invasive Sensors Alternative systems are becoming accepted by bioprocessing customers so we have developed modified port structures to integrate them into the S.U.B. These are now available for PreSens and Finesse sensors as custom options. Microbial Fermentation This application presents additional challenges for a single-use system. We are developing a design to meet these challenges. Application Technology Our application engineers and cell culture scientists continue to expand the range of cell platforms used with the S.U.B. Worldwide Support, Advancing Technology Antibody production in a 250 L system 120% 10 Cell growth in a 250 L system 100% Average Daily Antibody Concentration (% of final) 100% 80% 60% 40% 20% 0% Day of Run Average Daily Viable Cell Concentration (millions cells/ml) % 80% 70% 30% 20% 10% 0% Day of Run 60% 50% 40% Viability (%) Single-Use Traditional Viable Cells, Single-Use Viable Cells, Traditional Viability, Single-Use Viability, Traditional In this experiment, a CHO line expressing humanized monoclonal antibody was cultivated in a protein-free chemically defined medium with a ph of 7.1. Oxygen was sparged at 0.2 L/min and agitation was 110 rpm. The graphs verify cell growth and antibody production in the S.U.B. were comparable with those in a conventional system. Error bars represent 95% confidence interval for the mean of five runs. Data provided by Baxter Healthcare Corp.

6 S.U.B. Hardware and BPC Ordering Information Hardware Electric Resistive Heater Product # Size Description SV L 120 VAC SV L 240 VAC SV L 120 VAC SV L 240 VAC SV L 120 VAC SV L 240 VAC SV L 240 VAC SV L Modbus Plus Load Cell Interface SV L Allen-Bradley Load Cell Interface SV L Analog Output Load Cell Interface SV L Profibus Load Cell Interface SV L DeviceNet Load Cell Interface Water Jacket Product # Size Description SV L 120 VAC SV L 240 VAC SV L 120 VAC SV L 240 VAC SV L 120 VAC SV L 240 VAC SV L 240 VAC SV L 240 VAC, Modbus Plus Load Cell Interface SV L 240 VAC, Allen-Bradley Load Cell Interface SV L 240 VAC, Analog Output Load Cell Interface SV L 240 VAC, Profibus Load Cell Interface SV L 240 VAC, DeviceNet Load Cell Interface BPC 20, 100, 250, 500 and 1000 L S.U.B. BPC Single-Use BPC (with MPC body) Product # Size Outer Container SH L SV SV SH L SV SV SH L SV SV SH L SV SV SH L SV SV Accessories A range of accessories is available for probe preparation, sampling and vent filter heating. In addition, we offer a variety of key spare parts. For further details, contact your sales representative for Thermo Scientific HyClone products. Sterile Sampling Manifold with Luer Locks Available to weld onto the sample line to take sample sets Product # Size SH Single Pack SH Pack

7 More Than Just a Bioreactor Supplier BioProcess Containers to Meet Your Requirements As the leading supplier of single-use BioProcess Containers (BPCs) we can provide product solutions for use with the S.U.B., all sharing the same contact surface. Standard products to cover most liquid handling applications are available for immediate delivery Our customization capabilities can provide you with a BPC solution to meet your special requirements Our BPC systems are scalable to match the volume of the S.U.B. range Ready-to-Use Media and Buffers We pioneered the supply of large volume ready-to-use sterile-filtered cell culture liquid media, supplements and buffers. Let us simplify your process, allowing you to concentrate on your core business. A range of optimized delivery systems for unit volumes up to 1000 L Expertise in GMP custom formulated media and buffers Media and Buffer Preparation Platforms The Thermo Scientific HyClone Single-Use Mixer (S.U.M.) platform shares the same mixing design principle and a greater volume range than the S.U.B. A variety of options up to 2000 L is available for both upstream and downstream applications. The S.U.M. integrates with Thermo Scientific HyClone Powdertainer II powder delivery system to form a closed powder-containment media and buffer preparation system Open-top system option is also available for applications where powder containment is not an issue We also supply simple tank liners up to 1500 L for those customers with a system based on a re-usable mixer Sampling or Supplementing Standard products are available with connection systems to suit your system of choice for sampling or supplement addition to the bioreactor. Thermo Scientific HyClone Labtainer BPCs range from 50 ml to 50 L Standard sampling manifolds are available for use with the S.U.B. We have supplied millions of liters of ready-to-use liquid media and buffers Our Single-Use Mixer gives you the option of either open-top or closed-system media and buffer preparation Single-Use Containers and Mixers, Media and Buffer Outsourcing Harvest and Storage Systems For harvest and storage of cell cultures we offer larger volume 3D BPC systems with a range of outer container options. Standard products suitable for harvest and storage applications up to 1500 L are available Custom options of up to 2000 L for use with the premier Thermo Scientific HyClone Smartainer II outer container system Our range of small volume Labtainer BPCs provide flexible functionality with our industry leading film Our Smartainer II outer container systems for critical environments

8 Cell Culture and BioProcessing In the Americas and Asia 925 West 1800 South Logan, Utah Tel: +1 (435) Toll-Free: +1 (800) HyClone Fax: +1 (435) In Europe Industriezone III, Industrielaan Erembodegem Belgium Fax Thermo Fisher Scientific Inc. All rights reserved. Allen-Bradley is a registered trademark of Rockwell Automation. DeviceNet is a registered trademark of ODVA. Kleenpak is a registered trademark of Pall Corporation. Modbus is a registered trademark of Modicon. Profibus is a trademark of Profibus International. All other trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. SM0497