Automated virus removal for clinical- to commercial-scale manufacturing

Planova™ Virus Filtration Systems

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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.

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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 ProcessPlanova 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 single-use 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

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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.

Typical System PhasesSoftware 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**

Select Your Automation PlatformOrder a Planova Virus Filtration System with an automation platform to match your site requirements. Three automation platforms are available:

*Only for Planova BioEX filters and stainless steel Planova Virus Filtration Systems.**Only for stainless steel Planova Virus Filtration Systems.

Automate your most important downstream processing step.

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Understanding Your ProcessAt 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.

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 GuideProduct Pool Volume (L)

100 250 500 1000 2000 2500 5000

Planova 20N

Available filter combinations* 1 x 1.0 m2 2 x 1.0 m2 1 x 4.0 m2 2 x 4.0 m2 3 x 4.0 m2 4 x 4.0 m2 7 x 4.0 m2

Planova Virus Filtration System Selection VFC008 VFC008 VFC008 VFC008

VFS106VFS106VFS108

VFS106VFS108 VFS110

Planova BioEX

Available filter combinations** 1 x 1.0 m2 2 x 1.0 m2 3 x 1.0 m2 5 x 1.0 m2 3 x 4.0 m2 4 x 4.0 m2 7 x 4.0 m2

Planova Virus Filtration System Selection 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/m2. **Based on theoretical concentration of 15 - 15 g/L and Planova BioEX filter loading of 200 L/m2.Actual filter loading and system selection is product and process-dependent.

Ordering Information

Note: Planova Virus Filtration Systems can be optimized for the Planova filter type of your choice.

Catalog No. Planova Filter Effective Surface Area

Number of Planova 20N Filters

Number of Planova BioEX Filters

Planova Virus Filtration System Type

VFC0081.0 m2 1 – 2 1 – 2

Standard4.0 m2 1 – 2 1

VFS1061.0 m2 3 – 4 2 – 4

Customized4.0 m2 1 – 4 1 – 2

VFS1081.0 m2 4 – 6 2 – 6

Customized4.0 m2 1 – 6 1 – 3

VFS1101.0 m2 8 – 10 4 – 5

Customized4.0 m2 2 – 10 1 – 5

Filters set for the VLT

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Single-use tubing assembly

Single-Use Virus Filtration SystemsDemand 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 single- use 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

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.

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.

Technical Support and Warranty Information

Contact Information

For more information, please visit: www.ak-bio.com

Planova is a registered trademark of Asahi Kasei Medical Co., Ltd.

© 2016 Asahi Kasei Bioprocess America, Inc. All rights reserved.

India and Southeast Asia

Mumbai, IndiaTel: +91-22-6710-3962Fax: +91-22-6710-3979

Email: info.jp@ak-bio.com

East Asia and Oceania

Glenview, IL, USATel: +1-847-556-9700 Fax: +1-847-556-9701

Email: info.jp@ak-bio.com

Europe

Cologne, GermanyTel: +49-221-995007-59Fax: +49-221-9950077-59

Email: info.eu@ak-bio.com

North and South America

Glenview, IL, USATel: +1-847-556-9700 Fax: +1-847-556-9701

Email: info.us@ak-bio.com

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