Abstract
AbstractIn 1989, Asahi Kasei commercialized a porous hollow fiber membrane filter (Planova™) made of cuprammonium regenerated cellulose, making it possible for the first time in the world to “remove viruses from protein solutions by membrane filtration”. Planova has demonstrated its usefulness in separating proteins and viruses. Filters that remove viruses from protein solutions, i.e., virus removal filters (VFs), have become one of the critical modern technologies to assure viral safety of biological products. It has also become an indispensable technology for the future. The performance characteristics of VFs can be summarized in two points: 1) the virus removal performance increases as the virus diameter increases, and 2) the recovery rate of proteins with molecular weights greater than 10,000 exceeds the practical level. This paper outlines the emergence of VF and its essential roles in the purification process of biological products, requirements for VF, phase separation studies for cuprammonium cellulose solution, comparison between Planova and other regenerated cellulose flat membranes made from other cellulose solutions, and the development of Planova. The superior properties of Planova can be attributed to its highly interconnected three-dimensional network structure. Furthermore, future trends in the VF field, the subject of this review, are discussed.
Publisher
Springer Science and Business Media LLC
Reference64 articles.
1. Adams B, Bak H, Tustian AD (2020) Moving from the bench towards a large scale, industrial platform process for adeno-associated viral vector purification. Biotechnol Bioeng 117(10):3199–3211. https://doi.org/10.1002/bit.27472
2. Adan-Kubo J, Tsujikawa M, Takahashi K, Hongo-Hirasaki T, Sakai K (2019) Microscopic visualization of virus removal by dedicated filters used in biopharmaceutical processing: impact of membrane structure and localization of captured virus particles. Biotechnol Prog 35:e2875. https://doi.org/10.1002/btpr.2875
3. European Medicines Agency/CHMP/BWP P: Guideline on virus safety evaluation of biotechnological investigation medicinal products EMEA/CHMP/BWP/398498/2005, 2008.7.24
4. European Medicines Agency/CHMP: Guideline on plasma-derived medicinal products. CPMP/BWP/269/95 rev.4, 2009.2.19
5. Aranha H (2001a) Viral clearance strategies for biopharmaceutical safety, part 1: general considerations. Biopharm 14(1):28–35
Cited by
9 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献