Performance of a Novel Viresolve NFR Virus Filter
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- 作者：Helene Brough ; Chris Antoniou ; Jeffrey Carter ; Jocelyn Jakubik ; Yuan Xu ; and Herbert Lutz
- 刊名：Biotechnology Progress
- 出版年：2002
- 出版时间：August 2002
- 年：2002
- 卷：18
- 期：4
- 页码：782 - 795
- 全文大小：229K
- 年卷期：v.18,no.4(August 2002)
- ISSN：1520-6033
文摘
Mammalian cell-expressed therapeutic proteins are particularly vulnerable to contamination by endogenous retrovirus-like particles (RVLPs). The Viresolve NFR filterwas designed to meet the critical requirement of manufacturing a safe and virus-freetherapeutic by retaining RVLPs by a minimum of six log reduction value (LRV). TheNFR designation refers to retrovirus removal in a normal flow format. To qualify theproduct, we tested two model viruses: the 78 nm diameter 
6 bacteriophage and the80-110 nm diameter Xenotropic Murine Leukemia Virus (X-MuLV). Robust retentionwas demonstrated over a wide range of process parameters. Viresolve NFR filters alsoretain other model adventitious viruses including 70-85 nm diameter Reovirus 3(Reo3), 70-90 nm diameter Adenovirus 2 (Ad2), and 53 nm diameter PR772 by >6LRV. In addition to these model viruses, the filter retains >7 LRV of both themycoplasma Acholeplasma laidlawii and the bacterium Brevundimonas diminuta.Protein passage is shown to be consistently high (95-100%) for a variety of therapeuticprotein products, including monoclonal antibodies. Characterization of the filter inspecific applications is made simple by availability of ultralow surface area (5 cm2)disks, which are shown to scale linearly to the manufacturing scale pleated-filters.Viresolve NFR filters provide consistent water permeability performance (34-37 LMH/psi) and show very little plugging for all feedstocks evaluated. The Viresolve NFRfilter incorporates Retropore, a unique asymmetric polyethersulfone membrane, thesurface of which has been modified to minimize protein binding.
6 bacteriophage and the80-110 nm diameter Xenotropic Murine Leukemia Virus (X-MuLV). Robust retentionwas demonstrated over a wide range of process parameters. Viresolve NFR filters alsoretain other model adventitious viruses including 70-85 nm diameter Reovirus 3(Reo3), 70-90 nm diameter Adenovirus 2 (Ad2), and 53 nm diameter PR772 by >6LRV. In addition to these model viruses, the filter retains >7 LRV of both themycoplasma Acholeplasma laidlawii and the bacterium Brevundimonas diminuta.Protein passage is shown to be consistently high (95-100%) for a variety of therapeuticprotein products, including monoclonal antibodies. Characterization of the filter inspecific applications is made simple by availability of ultralow surface area (5 cm2)disks, which are shown to scale linearly to the manufacturing scale pleated-filters.Viresolve NFR filters provide consistent water permeability performance (34-37 LMH/psi) and show very little plugging for all feedstocks evaluated. The Viresolve NFRfilter incorporates Retropore, a unique asymmetric polyethersulfone membrane, thesurface of which has been modified to minimize protein binding.