USD 2329a

Ultipor VF UDV20 Virus Removal Filter Cartridges

Robust, Stable Flowrate Small-Virus Removal Filter with Consistent, High Capacity Performance
Features
Incorporates Ultipor VF DV20 virus filter membrane Proven, reliable virus safety technology High filtration area per filter cartridge Robust, stable flowrate

Benefits
Robust, high viral clearance for small viruses Approved for use in licensed processes Maximizes process productivity, reduces Cost of Goods Stable flux rates achievable in a wide range of process conditions. Consistent performance (suitable for platform technology) Minimized flux decay Provides assurance of consistent performance per specification Enables a sterile process where required Reduces labor costs, minimizes risk of handling errors Enables the highest level of process control and safety

Resistant to plugging Rigorous quality testing Autoclavable and Steamable In Place (SIP) Automatic in-line integrity test Fully automated systems available

Description
The risk of virus contamination is ever-present in biologic products. Potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the cell line or product during from culture medium or during the production process (adventitious viruses). Viruses could potentially be present in donations for plasma derivatives. Ultipor VF UDV20 Virus Removal Filter Cartridges are direct flow filters that provide an efficient and economical method for removing even the smallest viruses from biological solutions.

Ultipor VF UDV20 filters meet the acceptance criteria of the Parenteral Drug Associations virus filter task force for smallpore-size virus-retentive filters. Ultipor VF UDV20 filter cartridges are characterized by robust and stable high performance, over a wide range of process conditions. The innovative hydrophilic PVDF membrane provides stable pressure/flux capabilities also in more complex or concentrated feeds. The unique, patented laid-over pleating technology provides 2x increased effective filtration area. This allows economical virus filtration of high concentrated protein solutions, without product dilution. Flow decay due to membrane plugging and gel polarization is minimized for a wide range of different process conditions and over long process times, which qualifies Ultipor VF UDV20 filters as platform technology.

Table 1 Effective Parvovirus Reduction Typical Parvovirus Reduction by Ultipor VF UDV20 Filters
Product Type mAb 1 mAb 2 mAb 3 mAb 4 mAb 5 mAb 6 mAb 7 hIgG 1 hIgG 2 hIgG 3 LRV PPV 6.3 > 5.8 > 5.0 4.2 > 4.8 > 6.6 MMV 6.2 > 5.8 5.1 B19 > 5.0

Figure 1 Resistance to Plugging Fouling Fluids

Flux (Lh-1) per 10 in. Cartridge 80

40

0 0 80 160 240 Protein Throughput (g/m2) UDV20 High Initial Flow Filter A (High Fouling) High Initial Flow Filter B (High Fouling) 320

Table 2 Effective Reduction of Large Viruses by Ultipor VF UDV20 Filters

Product Type mAb 1 mAb 2 mAb 3 mAb 4 mAb 5 mAb 6 mAb 7 mAb 8 mAb 9 mAb 10 hIgG 1 hIgG 2 hIgG 3 hIgG 4 >5 > 6.2 >5 > 4.6 >5 > 5.4 > 4.6 > 6.1 LRV HIV BVDV X-MuLV > 5.6 > 5.3 > 5.1 > 5.7 > 5.4 > 4.9 > 5.4 > 4.6 A-MuLV > 6.0 > 5.7

NOTE: Ultipor VF DV20 membrane flux profiles during filtration of serum IgG compared to high initial flow filter which show rapid flow decay in complex and concentrated fluids.

Due to its robust, stable flow and resistance to plugging even at high virus spike concentrations, no dilution of virus spike or exceptional virus spike purification is required, which allows the highest titer reduction claims for MuLV and other viruses.

Figure 2 Resistance to Plugging under Different Virus Spike Preparations

5% 5% 2% 2% 1% 1%

Spike Spike Spike Spike Spike Spike

Pall offers fully-automated virus filtration systems that enable precise and consistent operation, together with improved process efficiency. The systems can be designed with steam sterilization (SIP), automated cleaning (CIP) and integrity test in place (ITIP). The Cluster-Filtration Technology assures maximum filter integrity sensitivity. Pall fullyautomated virus filtration systems ensures the highest level of manufacturing safety and process performance.

Flux

Throughput Ultipor VF DV20 membrane flux profiles during duplicate viral challenge tests at different virus spike levels. The data are duplicate results from three separate monoclonal antibody solutions that required a variety of virus spike specifications.

The Ultipor VF UDV20 filter is an extension to the Ultipor VF Grade DV20 virus filter line. The high-filter-area-per-filtercartridge (due to its unique, patented laid-over pleating construction and narrow core) maximizes process productivity, reduces process costs and reduces the required amount of filter elements per installation, which minimizes the hold up volume of the virus filter system.

Figure 3 Pleating Comparison

Rigorous Quality Testing

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100% Integrity tested tested correlated to PP7 bacteriophage removal PP7 bacteriophage* lot release test 100% water flow test Protein transmission test Visual inspection control Quality Control at Multiple Production Stages

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DV20 filter cartridge showing fan pleat and standard core

UDV20 filter cartridge showing laid-over pleats and narrow core

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High Quality Standards

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Meets USP Biological Reactivity Test, in vivo, for Class VI121 C Plastics Meets Cleanliness per USP Particulates in Injectables Non-Fiber-Releasing Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL) Meets Total Organic Carbon and Conductivity per USP Purified Water; pH per Sterile Purified Water

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www.pall.com/biopharm

Technical Specifications
Materials of Construction Membrane Support and Drainage Layers Core, Cage and Endcaps Code 7 adapter O-rings Operating Conditions Recommended Operating DP Maximum Differential Pressure Hydrophilic modified polyvinylidenedifluoride (PVDF) Polyester Polypropylene Polypropylene with encapsulated stainless steel reinforcing ring Silicone

Typical Aqueous Extractables (NVR) < 15 mg per 254 mm (10 in) element, process-ready (after integrity testing, water flush and autoclaving) Filter Area (nominal) 2 m2 (22 ft2) per 254 mm (10 in.) element Forward Flow Integrity Test5 Diffusional flow integrity test, carried out by standard upstream or downstream methods
5

Correlated to > 3 log TR for 25 nm PP7 phage and > 6 log TR for 53 nm PR772 phage

1 to 3.1 bard (14.5 to 45 psid) 3.1 bar (45 psi) for continuous service, 0.3 bar (5 psi) during steam sterilization, 6.2 bar (90 psi) during integrity testing

Table 3 Process Scale-up with Pall Ultipor VF Grade DV20 Virus Filters

Filter Format Minidisc Capsule 47mm Disc in FTK200 Holder Novasip Capsule 10 in. Fanpleat 10 in. Laid-over Pleat

Part Number 10MCFDV20 FTKDV20047 CLM05DV20P1G AB1DV207PH4 AB1UDV207PH4

Nominal Filtration Area 0.00096 m2 0.0011 m2 0.07 m2 1 m2 2 m2

Autoclave/steaming1 Autoclavable or steamable in-situ for up to 3 cycles Maximum Temperature 125 C

1

Contact Pall for recommended procedures to qualify filters under actual conditions of use.

Removal Rating Small viruses2 Large viruses

2 3

3 Log TR3 6 Log TR4

See also Pall publication USTR 2612: Scalability of Ultipor VF Grade DV20 and UDV20 Virus Removal Filter Cartridges

Claims based on challenge with parovirus model bacteriophage (bacterial virus) PP7 > 4 LRV for PP7 bacteriophage per Parenteral Drug Association (PDA) TR 41 rating method for small virus-retentive filters. > 4 LRV typically with mammalian parvoviruses. Claim based on challenge on retrovirus model bacteriophage PR772 6 LRV typically also with mammalian retroviruses

Ordering Information
Pall Part Number: AB Code 1 2 3 Nominal Length 254 mm (10 in.) 508 mm (20 in.) 762 mm (30 in.) UDV20 Removal Rating 3 Log TR for viruses > 20 nm 6 Log TR for viruses > 50 nm 7 Adapter Style Double 226 O-ring with bayonet lock and finned end P H4 Seal Material Silicone elastomer

Specifications and Availability: The information provided is a guide to the part number structure and possible options. Product availability may be subject to change without notice. All specifications are nominal. The literature was reviewed for accuracy at the time of publication. For additional information, consult your local Pall distributor.

Visit us on the Web at www.pall.com/biopharm e-mail us at biotech@pall.com

United States 800.717.7255 toll free (USA) 516.484.5400 phone 516.801.9548 fax biotech@pall.com e-mail Europe +44 (0)23 9230 3303 phone +44 (0)23 9230 2506 fax BioPharmUK@europe.pall.com e-mail
International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

2010, Pall Corporation. Pall, , Novasip, Ultipor and Ultipleat are trademarks of Pall Corporation. indicates a trademark registered in the USA. Filtration. Separation. Solution.SM is a service mark of Pall Corporation.

04/10, PDF, UK GN10.3609

USD 2329a