PT  - JOURNAL ARTICLE
AU  - Blümel, Johannes
AU  - Ma, Junfen
TI  - Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
AID  - 10.5731/pdajpst.2018.009134
DP  - 2018 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 488--497
VI  - 72
IP  - 5
4099  - http://journal.pda.org/content/72/5/488.short
4100  - http://journal.pda.org/content/72/5/488.full
SO  - PDA J Pharm Sci Technol2018 Sep 01; 72
AB  - In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q5A(R1) outlines that “Over time and after repeated use, the ability of chromatography columns and other devices used in the purification scheme to clear virus may vary. Some estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns.” Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.LAY ABSTRACT: In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. An estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns. Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.