Particle‐based analysis elucidates the real retention capacities of virus filters and enables optimal virus clearance study design with evaluation systems of diverse virological characteristics

Author:

Kayukawa Taiki1ORCID,Yanagibashi Akiyo2,Hongo‐Hirasaki Tomoko3ORCID,Yanagida Koichiro3

Affiliation:

1. Medical Technology & Material Laboratory, Research and Business Development Division Asahi Kasei Medical Co., Ltd. Shizuoka Japan

2. Bioprocess Technical Development Division Asahi Kasei Medical MT CORP. Miyazaki Japan

3. Bioprocess Division Asahi Kasei Medical Co., Ltd. Miyazaki Japan

Publisher

Wiley

Subject

Biotechnology

Reference27 articles.

1. Viral contamination in biologic manufacture and implications for emerging therapies

2. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin;ICH Harmonized Tripartite Guideline Q5A (R1);US Fed Reg,1999

3. Guideline on virus safety evaluation of biotechnological investigational medicinal products;EMA,2008

4. Sterilizing filtration of liquids task force. sterilizing filtration of liquids. technical report no. 26 (revised 2008);PDA J Pharm Sci Technol,2008

5. Phage passage after extended processing in small-virus-retentive filters

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