Planova Virus Filtration Systems. Automated virus removal for clinical- to commercial-scale manufacturing

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1 Planova Virus Filtration Systems Automated virus removal for clinical- to commercial-scale manufacturing

2 Built For You. Asahi Kasei Bioprocess is dedicated to unlocking efficiencies and driving productivity within your biopharmaceutical and plasma derivative virus filtration processes. Viral safety is a fundamental regulatory requirement for the production of mammalian cell-based or plasma-based protein therapeutics. Our Planova Virus Filtration Systems combine extensive expertise in artisanal fluid management with the rich tradition of Planova filters to help you maintain the integrity of your biotherapeutic during clinical- through commercial-scale virus filtration. 2

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4 Innovative Engineering from a Virus Filtration Pioneer Following the protein capture and purification steps required for the production of biopharmaceuticals and plasma derivatives, nothing can be left to chance at the downstream stage of virus filtration. That s why, for the past decade, Asahi Kasei Bioprocess has leveraged knowledge of virus filtration, process development and automation to equip manufacturing facilities around the world with customized Planova Virus Filtration Systems. Scalability for Any Application Whether you re fractionating plasma, manufacturing monoclonal antibodies or producing recombinant proteins, Planova Virus Filtration Systems can manage up to ten Planova 15N, 20N, 35N or BioEX filters in parallel. Zero static valve manifolds minimize pressure loss and reduce hold-up volume within the multi-filter system. Flexibility for Your Process Planova Virus Filtration Systems can be designed for your unique requirements, balancing current production levels against anticipated future demand. Our ASME-BPE compliant stainless steel Planova Virus Filtration Systems accommodate singleuse bags and pressure tanks, allowing buffers and products to be stored in the format of your choice. Custom Single-Use Planova Virus Filtration Systems are also available if you wish to leverage disposable fluid management technology. Planova Virus Filtration System Options» Constant pressure or pump operation» Prefilter» Bubble traps» Positioning for visual leakage test (VLT)» Conductivity monitoring» Steam-in-place (SIP) configurations 4

5 Typical System Phases Software for Planova Virus Filtration Systems can be configured to operate the following steps:» System pressure test and SIP*» Pre-use VLT pressurization» Pre-use flush» Buffer equilibration (optional)» Product filtration» Product recovery flush (optional)» Post-use VLT pressurization» For Planova 15N, 20N and 35N filters only, gold particle test (GPT) pre-wash steps» System CIP** *Only for Planova BioEX filters and stainless steel Planova Virus Filtration Systems. **Only for stainless steel Planova Virus Filtration Systems. Select Your Automation Platform Order a Planova Virus Filtration System with an automation platform to match your site requirements. Three automation platforms are available: Allen-Bradley (Proficy ifix) Siemens DeltaV» Island of automation» Integrated batch engine Method Editor» Live and historical trending» Batch reports» OLE (Object linking and embedding) process control (OPC) complient» ANSI/ISA-88 compliant» Island of automation or integrated into plant-wide control system» Live and historical trending» Batch reports» OPC compliant» ANSI/ISA-88 compliant» Plant-wide control system» Integrated by our Emerson integration partners or your own Emerson integrator DeltaV is a trademark of Emerson Process Management. Automate your most important downstream processing step. 5

6 Understanding Your Process At Asahi Kasei Bioprocess, automation engineers work closely with Planova experts to incorporate process understanding with the highest level of efficiency and performance into each Planova Virus Filtration System. Filters set for the VLT This commitment to efficiency and understanding led to the incorporation of positioning for the VLT. Mount the Planova filter on a Planova Virus Filtration System, and you can perform the pre-use VLT, product filtration and post-use VLT without any additional handling. Planova Virus Filtration System Selection Guide Planova 20N Planova BioEX Available filter combinations* Planova Virus Filtration System Selection Available filter combinations** Planova Virus Filtration System Selection Product Pool Volume (L) x 1.0 m 2 2 x 1.0 m 2 1 x 4.0 m 2 2 x 4.0 m 2 3 x 4.0 m 2 4 x 4.0 m 2 7 x 4.0 m 2 VFC008 VFC008 VFC008 VFC008 VFS106 VFS106 VFS108 VFS106 VFS108 VFS110 1 x 1.0 m 2 2 x 1.0 m 2 3 x 1.0 m 2 5 x 1.0 m 2 3 x 4.0 m 2 4 x 4.0 m 2 7 x 4.0 m 2 VFC008 VFC008 VFS106 VFS108 VFS108 VFS110 VFS110 Customized *Based on theoretical concentration of 5-15 g/l and Planova 20N filter loading of 200 L/m 2. **Based on theoretical concentration of g/l and Planova BioEX filter loading of 200 L/m 2. Actual filter loading and system selection is product and process-dependent. Ordering Information Catalog No. VFC008 VFS106 VFS108 VFS110 Planova Filter Effective Surface Area Number of Planova 20N Filters 1.0 m m m m m m m m Number of Planova BioEX Filters Planova Virus Filtration System Type Standard Customized Customized Customized Note: Planova Virus Filtration Systems can be optimized for the Planova filter type of your choice. 6

7 Single-Use Virus Filtration Systems Demand for single-use technologies in downstream processing continues to grow, and at Asahi Kasei Bioprocess, we understand that this may mean the implementation of a singleuse system for your clinical- or commercial-scale Planova virus filtration unit operation. We manufacture custom Single-Use Virus Filtration Systems (SU-VFS) which offer many advantages over pump and tubing filtration set-ups. Choose from our ifix, Siemens and DeltaV software platforms for your SU-VFS to permit automated virus filtration. Overmolded single-use tubing assemblies can be gamma irradiated at your option and are available with aseptic connectors to mate with your feed and permeate single-use bags. The following tubing assemblies can be customized for your SU-VFS:» Feed tubing assembly with single-use flowmeter, single-use pressure sensor and single-use pump head» Permeate collection tubing assembly with single-use pressure sensor» Tubing assembly with drain connection» Tubing assembly with vent connection» Air inlet tubing assembly for VLT Single-use tubing assembly For closed system operation, tubing assemblies can be procedurally connected to the Planova filter. Please contact your local account manager for more information about closed system operation. Single-use equipment designed to respect your individual needs. 7

8 Contact Information North and South America Europe India and Southeast Asia East Asia and Oceania Glenview, IL, USA Tel: Fax: Cologne, Germany Tel: Fax: Mumbai, India Tel: Fax: Glenview, IL, USA Tel: Fax: Technical Support and Warranty Information A reliable technical support network is available throughout the United States, Europe and Asia. We offer an extendable 1-year warranty, service contracts and a personalized level of service for peace of mind and timely support when you need it. For more information, please visit: Planova is a registered trademark of Asahi Kasei Medical Co., Ltd Asahi Kasei Bioprocess America, Inc. All rights reserved. UME91V01-3.0