Viresolve® NFR Filters
Viresolve® NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources.
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Viresolve® NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources. 간단히
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개요
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Documentation
References
| Reference overview |
|---|
| Validation of Virus Filtration Carter, Jeff and Herb Lutz BioProcess International January 2003: 52-62 2003 |
| Performance of a novel viresolve NFR virus filter. Brough Helene; Antoniou Chris; Carter Jeffrey; Jakubik Jocelyn; Xu Yuan; Lutz Herbert Biotechnology Progress 18 (4):p782-795 July-August, 2002 2002 요약 표시 Many biological drugs are recombinant proteins produced from mammalian cells. The safe use of these drugs requires freedom from contamination, particularly by viruses. Mammalian cells, while necessary to pharmacological production, introduce safety risks because they also produce endogenous retrovirus-like particles or RVLPs. Since therapeutic proteins and their contaminants have the same cell-based sources, it is necessary to physically separate the proteins from the RVLPs. To meet this need, Millipore Corporation has developed the Viresolve NFR filter, which removes typical RVLP contaminants from mammalian therapeutic proteins without retaining the proteins. To quantitatively verify the capability of the Viresolve NFR filter for use in this pharmacological purification, scientists at Millipore Corporation and Genentech, Inc. performed studies that were published in the Journal of Biotechnology (August 2002). The authors selected two model viruses that are characteristic of RVLP’s in their diameters: f 6 bacteriophage (78 nm diameter) and xenotropic murine leukemia virus (X-MuLV, 80-110 nm diameter). Results consistently and robustly showed the retention of these viruses: their concentrations in the filtrate were reduced by a factor of greater than one million (over six logs). While retaining these viral contaminants, the Viresolve filter avoids retaining the proteins: the protein passage rate is consistently between 95 and 100 percent. These filters are shown to scale linearly with high process fluxes of 500 – 1,000 LMH. |
| Removal of prion challenge from an immune globulin preparation by use of a size-exclusion filter VAN HOLTEN Robert W; AUTENRIETH Stephen; BOOSE Jeri Ann; HSIEH W T; DOLAN Sherri Transfusion : (Philadelphia, PA), 2002, 42 (8) 999-1004 2002 |
| An overview of viral filtration in biopharmaceutical manufacturing Jeffrey Carter and Herbert Lutz, Millipore Corporation, Bedford, MA, USA; European Journal of Parenteral Sciences 2002; 7(3): 72–78 © 2002 Parenteral Society European Journal of Parenteral Sciences 2002; 7(3): 72–78 © 2002 Parenteral Society 2002 |
| Development and Qualification of a Novel Virus Removal Filter for Cell Culture Applications Shengjiang Liu, Mark Carroll, Raquel Iverson, Christine Valera, Joann Vennari, Kimberly Turco, Robert Piper, Robert Kiss, Herbert Lutz Biotechnology Progress 2000 |
| Filtration and the Removal of Viruses from Biopharmaceuticals Levy, Richard V., Michael W. Phillips, and Herbert Lutz Chapter 20 in Filtration in the Biopharmaceutical Industry. New York: Marcel Dekker, Inc., 1998. 1998 |
| A Validatible Porosimetric Technique for Verifying the Integrity of Virus-Retentive Membranes Michael W. Phillips and Anthony J. DiLeo Advanced Separations Research Department, Millipore Corporation, 80 Ashby Road, Bedford MA 0 1 730, U.S.A. Biologicals. 1996 Sep;24(3):243-53. 1996 |
| High Resolution Removal of Virus From Protein Solutions Using A Membrane of Unique Structure DiLeo, Anthony J., Anthony E. Allegrezza, and Stuart E. Builder Bio/Technology (February 1992): 182-188; RP002 1992 |
관련 제품 및 어플리케이션
제품 패밀리
OptiScale-25 Capsules with Viresolve NFR MembraneViresolve NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources.더 보기 >> |
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Opticap XL and XLT Disposable Capsule Filters with Viresolve NFR MembraneViresolve NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources.더 보기 >> |
관련 제품: Application Facete
| Antibody Purification |
| Protein Purification |
| Dialysis and Filtration |
관련 제품: Brand Facete
| Viresolve® |
카테고리
| Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve NFR |
Description
Viresolve NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources. Viresolve NFR filters are ideal for polishing monoclonal antibodies, and provide an easy-to-implement technology that eliminates retrovirus contaminants in essential media and protein feed streams. When placed downstream of a bioreactor, Viresolve NFR filters minimize infection risk caused by viruses common to mammalian cell expression systems.
≥ 6 log removal of retroviruses
> 98% recovery of protein
- Robust processing
- Fast alcohol-free integrity testing
- Multiple formats available for easy scaling
- Each lot is 100% integrity tested
Fast, Reliable Clearance
Cast from polyethersulfone, Retropore membrane exhibits a patented void-free pore structure characterized by superior clearance and high flow rates. Denser internally than on its surface, the asymmetrical matrix of the membrane effectively traps large viruses and efficiently passes smaller proteins.
By providing fast and highly reliable clearance, Viresolve NFR filters improve product safety and protect downstream processes.
High Yields and Product Quality
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide > 98% protein product yields, while low extractables ensure product quality. Retropore membrane technology passes proteins up to 700 kDa and consistently clears retroviruses at > 6 LRV (Log Reduction Value).
Regulatory Compliance
All Viresolve NFR filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to ISO® 9001. Viresolve NFR capsules and cartridge filters are integrity tested during manufacturing and are supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is shipped with a Certificate of Quality in a sealed bag clearly labeled with the product name and identifying characteristics. Code 7 cartridges come with SMART Technology. This SMART filter has an embedded RFID tag preloaded with Catalogue Number, Lot Number, Serial Number and cartridge specific diffusion value.
Millipore has submitted a Biological Master File to the FDA and will submit it to other worldwide regulatory agencies needed to support customer applications. Please contact Millipore to obtain a Letter of Authorization to reference in your application.
Virus Retention
Pleated filters and OptiScale-25 disposable devices have been extensively tested using the 78 nm diameter Φ6. This bacteriophage is readily grown to monodispersed, uniform size, high titer challenges. A consistent >6.5 LRV has been observed over the range of feedstock and processing conditions shown in Table 2.
Multiple Formats Available
Viresolve NFR with Retropore membrane is available in three formats and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Choose the format that’s right for your process requirements:
- OptiScale®-25 disposable capsule filters
- Opticap XL and XLT disposable capsule filters
- Cartridge filters
Cartridge Filters
Viresolve NFR 10-, 20- and 30-inch cartridge filters are ideally suited for processes that require maximum pressure differentials. Each cartridge is integrity tested during the manufacturing process. A range of filtration areas is available to suit medium and large volume requirements.
| Cartridge Filters (per 10-inch cartridge) | ||
| Materials of Construction | ||
| Filter | Polyethersulfone (PES) | |
| O-ring | Silicone (SI) | |
| Cage; Core; Support | Polypropylene | |
| Effective Filtration Area, m2 | 0.43 m² | |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 bar (80 psid) @ 25 °C. Reverse: 3.4 bar (50 psid) @ 25 °C | |
| Sterilization | After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C, using liquid cycle, slow exhaust. |
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| Wetting/Flushing | Water wet filter for 10 min at 2 bar (30 psi) or for 5 min at 3.4 bar (50 psi) to a volume of 75 L/m2. | |
| Non-volatile residue (NVR) | The extractables level was equal to or less than 35 mg per 10-inch cartridge after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature. | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L | |
| Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | |
| Air Diffusion at 23 °C | ≤16 mL/min @ 3.45 bar (50 psig) in water | |
| Thermal and Hydraulic Stress | Lot release testing on autoclaved samples at 25 °C exhibited integrity after a forward stress to 5.5 bar (80 psid) and a reverse stress to 3.4 bar (50 psid). | |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | |