Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes
Summary: Virus removal filtration during the manufacturing process plays an essential role in ensuring the virus safety of biologics. Following the revision of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q5A, the guidelines for the virus...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-02-01
|
| Series: | iScience |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589004224029286 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832590863622995968 |
|---|---|
| author | Tomoko Hongo-Hirasaki Hiroki Fukutomi |
| author_facet | Tomoko Hongo-Hirasaki Hiroki Fukutomi |
| author_sort | Tomoko Hongo-Hirasaki |
| collection | DOAJ |
| description | Summary: Virus removal filtration during the manufacturing process plays an essential role in ensuring the virus safety of biologics. Following the revision of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q5A, the guidelines for the virus safety of biopharmaceuticals now state that an effective viral clearance process should achieve a viral reduction of 4 log10 or greater. Technological advances in the development of new manufacturing technologies for continuous production and the development of next-generation antibody drugs have increased the need for virus removal filters suited to a variety of applications. The newly available virus removal filter, Planova S20N, incorporates a newly developed regenerated cellulose hollow fiber membrane. In addition to stable filtration of a variety of antibody solutions, this filter demonstrates robust parvovirus removal under a variety of filtration operating conditions, including low flow rate filtration for continuous process. |
| format | Article |
| id | doaj-art-1018182e85b041898049edc30f46988d |
| institution | Kabale University |
| issn | 2589-0042 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | iScience |
| spelling | doaj-art-1018182e85b041898049edc30f46988d2025-01-23T05:27:35ZengElsevieriScience2589-00422025-02-01282111701Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranesTomoko Hongo-Hirasaki0Hiroki Fukutomi1Scientific Affairs Group, Bioprocess Division, Asahi Kasei Medical Co., Ltd., Nobeoka, Miyazaki 882-0031, Japan; Corresponding authorScientific Affairs Group, Bioprocess Division, Asahi Kasei Medical Co., Ltd., Chiyoda-ku, Tokyo 100-0006, JapanSummary: Virus removal filtration during the manufacturing process plays an essential role in ensuring the virus safety of biologics. Following the revision of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q5A, the guidelines for the virus safety of biopharmaceuticals now state that an effective viral clearance process should achieve a viral reduction of 4 log10 or greater. Technological advances in the development of new manufacturing technologies for continuous production and the development of next-generation antibody drugs have increased the need for virus removal filters suited to a variety of applications. The newly available virus removal filter, Planova S20N, incorporates a newly developed regenerated cellulose hollow fiber membrane. In addition to stable filtration of a variety of antibody solutions, this filter demonstrates robust parvovirus removal under a variety of filtration operating conditions, including low flow rate filtration for continuous process.http://www.sciencedirect.com/science/article/pii/S2589004224029286Microbial biotechnologyBiomedical materialsBiosafety |
| spellingShingle | Tomoko Hongo-Hirasaki Hiroki Fukutomi Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes iScience Microbial biotechnology Biomedical materials Biosafety |
| title | Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| title_full | Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| title_fullStr | Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| title_full_unstemmed | Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| title_short | Performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| title_sort | performance features of virus removal filters with novel regenerated cellulose hollow fiber membranes |
| topic | Microbial biotechnology Biomedical materials Biosafety |
| url | http://www.sciencedirect.com/science/article/pii/S2589004224029286 |
| work_keys_str_mv | AT tomokohongohirasaki performancefeaturesofvirusremovalfilterswithnovelregeneratedcellulosehollowfibermembranes AT hirokifukutomi performancefeaturesofvirusremovalfilterswithnovelregeneratedcellulosehollowfibermembranes |